Medicines Control Agency of The Gambia 5-Year Strategic Plan 2019-2023

1.1. NATIONAL DEVELOPMENT PLAN FOR THE GAMBIA ................................... 6

1.2. NATIONAL HEALTH SECTOR POLICY AND STRATEGIC PLAN ................... 6

1.3. NATIONAL DRUGS POLICY .................................................................................. 7

1.4. THE NATIONAL PHARMACEUTICAL SERVICES .............................................. 7

1.5. THE MEDICINES AND RELATED PRODUCTS ACT, 2014................................. 7

1.6. THE MEDICINES CONTROL AGENCY (MCA), THE GAMBIA ......................... 8 2. SITUATIONAL ANALYSIS ............................................................................................. 8 3. ENVIRONMENTAL ANA YLSIS ..................................................................................... 9

3.1. SWOT ANALYSIS ..................................................................................................... 9

3.2. PESTEL ANALYSIS ................................ ...................................................... .......... I I 4. MANDATE, VISION, MISSION .................................................................................... 12

4.1. MANDATE ......................... ............................................................................ .......... 12

4.2. VISION ..................................................................................................................... 12

4.3. MlSSION .................................................................................. ...................... .......... 12 5. STRATEGIC GOALS, OBJECTIVES AND ACTIVITIES ............................................ 13

5.1. STRATEGIC GOALS............................................................................................... 13

5.2. SPECIFIC OBJECTrYES AND ACTJVlTIES ... ...................................................... 13 6. GUIDING PRINCIPLES AND STRATEGY .................................................................. 18 6. 1. GOOD REGULATORY PRACTICES ..................................................................... 18

6.2. TECHNICAL ADVISORY COMMITTEES............................................................ 19

6.3. INTERNATIONAL HARMONIZATION ..................................................... .......... 19

6.4. DECENTRALIZATION .............................................................................. ... .......... 19

6.5. HUMAN RESOURCE MANAGEMENT ................................................................ 19

6.6. MONITORING AND EV ALU ATI ON .......................................................... .......... 20 7. ORGANIZATIONAL CULTURE AND ETHICS .......................................................... 20 8. GOVERNANCE STRUCTURE ...................................................................................... 21

8.1. GOVERNING BOARD ............................................................................................ 21

8.2. MANAGEMENT ......................................................................................... ............. 22 Page iv of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 EXECUTIVE SUMMARY The Medicines Control Agency (MCA) was established under the Medicines and Related Products Act, 2014 with the mandate to regulate and control the manufacture, importation, exportation, distribution, use and advertisements of medicines and related products with respect to ensuring their quality, safety, and efficacy in The Gambia. The law defines medicines to include a substances or mixture of substances prepared, sold or represented for use in the diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal physical state or the symptoms of it, in man or animal; restoring, correcting or modifying organic functions in man or animal; nutritional supplements, or herbal medicines. Related product has been defined by the Act to mean an article other than medicine which includes cosmetics, homeopathic medicines, medical device, instrument or apparatus including, components, parts and accessories of it, manufacnired, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abno1mal phys ical state, or the symptom of it in man or animal. Upon the settin g up of the Agency by the appointment and inauguration of the Board and the appointment of the Executive Director and some other critical staff, it has become imperative to have a guide that will provide a strategic direction for the Agency over the next five years. The F ive-Year Strategic Plan 2019-2023 is therefore deve loped based on the mandate given by the Act, experi ences and lessons learnt over the last three years of the existence of the Agency, international best practices and results of some internal and environmental assessments undertaken so far. The purpose of this first Strategic Plan is to: I. Design strategies for achieving the vision, mission and objectives of the Agency. 2. Provide a long-term perspective of what the Agency would look like in the future. 3. Deve lop performance indicators for monitoring and evaluation . . 4. Develop an Operational Plan and budget as a bas is to seek for both technical and financial assistance to facilitate the achievement of the set objectives. The process of developing this Strategic Plan involved assessment of the state of medicines and related products regulation by the World Health Organization in 2016 during w hic h Board members, professional bodies, partners and private sector players were engaged. Additionally, there was a self-assessment of the MCA on its regulatory functions us ing the World Health Organization (WHO) Global Benchmarking Tools, and a further assessment on Quality Management Systems situation by WAHO. A ll levels of management, staff and various stakeholders and professional groups were engaged for their inputs and buy-in. Upon perform ing a SWOT and PESTEL analysis, vision and mission statements were developed and strategic goals identified to be able to achieve the mission of the MCA. Page 5 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 Strategic Goals • Establish an effective and efficient medicines and re lated products regulatory system • Mobi]ize technical and financial resources for the implementation of Regulatory Functions • Set up a functioning Quality Control Laboratory to support regulatory activities • Set up a Quality Management System (QMS) and undertake Operational Research activities to support regulatory functions • Develop and Implement an effective Information Management System • Promote Partnership and Cooperation 1. BACKGROUND I.I. NATIONAL DEVELOPMENT PLAN FOR THE GAMBJA The National Development Plan for The Gambia (20 18 - 2021 ) among its strategic priorities seeks to strengthen the provision of logistics, infrastructure, equipment, trans port and supplies at all levels. T he NOP refers to the National Medicines Pol icy (NMP) which aims to contribute to the attainment of quality health services for the population by ensuring tlte continuous availability a nd accessibility of essential medicines and other health commodities of appropriate quality, safety, and efficacy and by promoting their rational use. It further states that Government will collaborate with other stakeholders to strengthen an effective and sustainable Supply Chain Management System for drugs, surgical and other commodities including bas ic equipment. Furthermore, Government will invest in laboratory and diagnostic equipment, supplies and reagents for improvement in clinical diagnos is and management. The plan identifies leadership and governance, which deals with ensuring strategic policy frameworks combined with effective oversight, coalition building, accountability, regulations, incenti ves, and attention to health systems design, as the weakest component of the health system in the Gambia. The Strategic Plan of the Medicines Control Agency wi ll be in line to address this gap as far as the regulation of medicines and related products are concerned.

1.2. NA'fIONAL HEALTH SECTOR POLICY AND STRATEGIC PLAN The National Health Policy 201 2- 2020 sets some key objectives that include: • To ensure available and affordable essential medicines that are safe, efficacious and of the required quality; • To ensure availability of consumption data on medicines and other medical supplies. Policy measures set out to achieve the above objectives include transforming the supply management system for essential medicines for the public sector into a semi-autonomous institution, advocating for increased government funding for pharmaceuticals, improvi ng the drug supply system and promoting the rational use of medicines and supp lies, s trengthening the National Medicines Regulatory Authority and enacting the necessary laws toward attaining quality products, encouraging greater private sector involvement in the provision of essential medicines especially for the rural communi ty, establishing qual ity control testing of pharmaceuticals and strengthening and maintaining the Logistics Management Information System (LMIS). A number of the policy measures including the review of tl1e law and setting Page 6 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 up of the Medicines Control Agency have already been achieved. The Strategic Plan therefore will give direction to the operationalization of the MCA to improve its performance. l.3. NATIONAL DRUGS POLICY The Gambia has a Natio nal Drugs Policy that was last reviewed in 2007 w hich makes provisions for local drug production, storage, distribution, disposal of unwanted drugs, quality assurance, drug legislation and contro l of advertising and promotion among others. The policy makes a commitment that any deficiencies in the then existing legislation, the Medicines Act (1984) and the Medicines Regulations (1986), and the Drug Control Act (2003), will be rectified by amendments to the legislation, and/or drafting of additional legislation or regulations, which w ill be carried out in consultation with all affected parties. This resulted in the need for ·the establishment of an autonomous Medicines Regulatory Authority to address the gaps in legislation and regulatory functions . Assessment of the then Medicines Board was done followed by the review and updating of the legislation and finally leading to the passing of the Medicines and Related Products Act, 20 14 and the Pharmacy Council Act, 2014 that set up the Medicines Control Agency and the Pharmacy Council, respectively.

1.4. THE NATIONAL PHARMACEUTICAL SERVICES Up to December 20 14, the National Pharmaceutical Services (NPS) under the Ministry of Health was in charge of matters of drug policy, government procurement, storage, distribution and use of medicines. It also had an arm, the Medicines Board, which was responsible for medicines regulation and pharmacy practice. Among the achievements made by t]1e Medicines Board in preparation for the current dispensation were: • Development of vari ous guidelines and forms to guide the implementation of regulatory activities; • Trained staff on inspectorate activities • Set up a functioning Mini lab and trained quality control laboratory staff; • Planned the preparation of a register of listed products in The Gambian market; • Conducted inspection activities; • Facilitated the drafting of the Medicines and Related Products Act, 20 14 and the Pharmacy Counci l Act, 20 14 which were enacted into law by the Gambian Legislature, signed by the President of The Gambia and printed into handbills leading to tllle establishment of the Medicines Control Agency and the Pharmacy Council.

1.5. THE MEDICINES AND RELATED PRODUCTS ACT, 2014 The Medicines and Related Products Act, 2014 ("Act") was passed and signed by the President on 2611, December 20 14 to regulate the quality, safety and efficacy of products regulated under this Act. The Act makes provisions for: • Governance and functions of the Agency • Finances of Agency • Types of licenses to be issued Page 7 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 • Control of sale, information and advertising • Manufacturing, import and export controls • Registration of Products and granting of marketing authorization • Scope of Products to be regulated • Clinical Trials and Medicines Safety Monitoring (Pharmacovigilance) • Market Controls and Anti-counterfeiting • Control of Narcotics and Psychotropic substances for medical use • Quality Control of medicines and related products • Power to make regulations Regu latory functions covered under this law are Product Registration and Marketing Authori zation, Licensing, Inspection, Quality Control, Clinical Trials, Post-Marketing Surveillance, Pharmacovigilance and Advertisement and Promotion.

1.6. THE MEDICINES CONTROL AGENCY (MCA), THE GAMBIA The Medicines and Related Products Act, 20 14 led to the establishment of the Medicines Control Agency ("Agency") in March 2015 as the regulatory body respon:sible for the regulation and control of the quality, safety and efficacy of products regulated under this Act. The Governing Board made up of a Chairperson; the Permanent Secretary of the Ministry of Health; a representative of the Medical and Dental Association; the Director General of the National Drug Enforcement Agency; the President of the Pharmaceutical Society of Gambia; the Registrar of the Pharmacy Council; the Director of National Pharmaceutical Services; a representative of the Veterinary Practitioners Association; a representative of the Consumer association; a representative of the Herbal Practitioners Association; a legal practitioner from the Attorney General Chambers not below the rank of a Senior State Counsel; and the Executive Di rector of the Agency, who is the secretary to the Board has been constituted and inaugurated. The Board is mandated to ensure the proper and effective performance of the functions of the Agency enshrined in Section 4 of the Medicines and Related Products Act, 2014. An Office and Operational Premises has been acquired as temporary offices r,ented for the MCA. 2. SITUATIONAL ANALYSIS A desk review of existing documentation was done, including a review of the National Development Plan for The Gambia, National Health Sector Policy and Strategic Plan, National Drug Policy, Medicines and Related Products Act, 2014 and The Pharmacy Council Act, 2014. This was fo llowed by internal and external stakeholder consultations. T he following stakeholders were involved in the process: • Medicines Control Agency Staff; • Medicines Control Agency Board Members; • Private sector stakeholders such as Importers and Wholesalers of medicines; • Public sector, NGOs and International Organizations; • Pharmacy Council Members. Page 8 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 As part of the process courtesy calls were paid to the following: • Minister of Health of The Gambia; • World Health Organization Representative for The Gambia; • Executive Director, Drug Law Enforcement Agency of The Gambia (DLEAG). The following key issues were identified based on the outcomes of the reviews, stakeholder consultations and field observations: a. Current systems in place for control of imports are not res ilient enough and most players in the industry expect this to be strengthened in order to improve tbe quality of medicines and related products in the country; b. Currently there are overlaps in some functions stipulated in the Medicines and Related Products Act and the Pharmacy Council Act with respect to the Inspection and Licensing of Pharmaceutical Premises. However, this issue was recognized and resolved through a Memorandum of Understanding (MOU) between the Medicines Control Agency and Pharmacy Council; c. Inadequate inspection and non-regulation of storage facilities in both tlue public a11d private sectors; d. Illegal sale of medicines in the open market; e. Inadequate Human Resources for the MCA; f. Inadequate office space, laboratory and other physical infrastructure; g. Inadequate public education on the safe use of medicines and related products; h. Insufficient decentr-dlization of the activities of the MCA. 3. ENVIRONMENTAL ANAYLS lS

3.1. SWOT ANALYSIS This analysis is aimed at categorizing the issues identified into internal and external factors affecting MCA which will be usefu l in planning a strategy to address them. a. The analysis of internal factors focused on the: • Internal abi lities which the MCA could use or build upon to achieve its goals (s trengths). • Internal abilities that are available on a reduced scale, unable to serve as the basis of support for the MCA and which may become internal obstacles to the achievement of its mandate (weaknesses). b. The analysis of the external factors focused on issues external to the MCA, they included: • Issues that could be beneficial to the MCA in achieving its mandate (opportu11ities). • Issues that could hinder the MCA from achieving its mandate (threats). Page 9 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 STRENGTHS WEAKNESSES The identified strengths of the MCA are as The following weaknesses were noted: follows: • Inadequate office infrastructure • Enactment of the Medicines and Related • No Quality Control Laboratory Products Act 20 I 4 and establishment of • Inadequate institutional capacity for MCA as an autonomous body medicines and related products • Listing and registration of medicines and regulation and quality control related products currently on The Gambian market • Inadequate technical expertise both in • Availability of Draft Regulations 2018 terms of sufficient numbers and mixed appropriate skills • Availability of regulatory guidelines, SOPs and relevant tools • Inadequate logistical suppo1t for running • Availabi lity and implementation of a MCA operations Quality Management System (QMS) • Inadequate financial resources plan; • inadequate public awareness on the • Inspections, Post-Marketing Surveillance workings of the MCA and Pharmacovigilance Activities • Inadequate education of the general • System in place for authorization of public on safe use of medicines and Clinical Trials related products. • Presence ofan organizational structure • Lack of Monitoring and Evaluation • Availabi lity of a Quality Assurance Plan framework for the MCA services 2017 for products regulated by the • Limited ICT infrastructure for the Agency institutional, effective admiJ1istration, • Self-benchmarking of MCA using the archiving and managerial efficiency WHO G lobal Benchmarking Tool • Adapted the WAHO Common Teclmical Document fo r registration of medicines. • Availabi lity of annual work plans • Availabi lity of MCA Procurement Manual 2018. OPPORTUNITIES THREATS • Political commitment to support • T he potential for other state agencies and medicines and related products professional bodies to consider some regulation - demonstrated by the aspects of the MCA functions as an enactment of the Medicines and Related overlap on the ir functions or ro les Products Act 2014 leading to conflict • Existence of development partners and • Inabi lity of government to adequately diseases control programs to support the fund the activities of the MCA development of the human and technical • T he tendency for some stakeholders or resources to the MCA business interests to view the MCA as an Page 10 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 • Collaboration with other Medicines additional bureaucratic bottleneck that Regu latory Authorities within the sub- may affect their usual way of doing region and globally in the areas of business inforrntion s haring, harmonization of • Presence of fake and substandard medicines regulation, capacity building, medicines in the market etc • Lack of functional QC Laboratory • Recognition on the part of key • 1nadequate financ·ial suppon fior stakeholders with regards to the sustainability of regulatory activ ities importance of medicines regulation in achieving national healthcare objectives • The absence of the requis ite technical base in country to support the operations • Potential for collaboration with state and of the MCA such as control of clinical security agencies such as Customs, trials, regulation of biologicals and new Gambia Ports Authority, Police, DLEAG health technologies. and National Environmental Agency and professional bodies e.g. Pharmacy, • Risk of public out cry if it is general Medical and Dental, Nurses and knowledge that medicines used in the Veterinary Councils to enhance the country are not subject to any quality Agency's regulatory activities. testing at country level.

3.2. PESTEL ANALYSIS POLITICAL The political dispensation in The Gambia hopes to provide a new focus and a new direction as far as health is concerned. National policies on health as well as Ministerial Health Policies and strategies are likely to gather a new momentum of implementation. Currently, the operational cost of the MCA (e.g. salaries, renting of office space, vehicle) is bei11g met by the Government of the Gambia (GoG) through the disbursement of its subvention by Ministry of Finance. However, the increase in its allocation is necessary for MCA to build its capacity and improve services and these will affect the strategic direction of the MCA. ECONOMJC The MCA is a government subventcd Agency and will definitely be affected by national budget and economic health. For that matter budgetary allocations to the Agency which is, the main income source of the Agency, the internally generated funds obtained from fees charged, is likely to be affected by overall economy and purchasing power of the country. SOCIAL Like any developing country south of the Sahara and within the ECOWAS region, there is a high disease burden that calls for multisectoral approach to health provision. Availability of a wide variety of medicines and related products are available through government or the private sector. Inadequate regulation of such products is likely to affect health outcomes. With the general literacy rate in the country, general attitude towards quality and safety of products calls for effective medicines and related products regulation. Page 11 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 TECH NOLOGICAL The depth of penetration of mobile technology within the country provides a very useful opportunity for information dissemination on product quality, safety and efficacy. It also provides an avenue for participation of the citizenry in regulation through a properly organized feedback system. Technology will be harnessed internally to improve on inter-departmental communication and thereby improve efficiency and effectiveness. Teclmology externally will improve inf01·mation dissemination to professionals, applicants and the general public. Mobi le phone technology could be used for authentication of registered products by the genernl public as a means of fighting the presence of substandard and falsified medicines and related products on the Gambian market. ENVJRONMENT AL Work culture and ethics of the general population including staff and clients of the MCA are likely to influence the workings of the Agency. The plurality of the press, both print and electronic, presents as a strength and opportunity for the operations of the MCA. The presence of other agencies in the regulatory space and the perceived overlap of functio n a lso pose a threat to the MCA. LEGAL The existence of an enabling law that provides the legal basis for the regulation of medicines and related products clearly sets the scope and extent of the working of the MCA. The Gambia is also a member of international health agencies like the WHO and UNICEF. Additionally, it is a signatory to various international conventions including the International Conventions on Narcotics and Psychotropic substances that provide addition legal basis and benchmarking. 4. MANDATE, VISION, MISSION

4.1. MANDATE The Medicines and Related Products Act, 2014 establ ished the Medicines Control Agency (MCA) with the mandate to regulate and control the manufacture, importation, exportation, distribution, use and advertisements of medicines and related products with respect to ensuring their quality, safety, and efficacy. Related products include homeopathic medicines, cosmetics, medical devices and household chemicals substances.

4.2. VIS ION A Medicines and Related Products Regu latory Agency of Excellence.

4.3. MISSION The Medicines Control Agency, The Gambia exists to achieve the highest possible standards of quality, safety and efficacy for medicines and related products by employing effective, efficient and transparent regulatory systems using competent and highly motivated human resource to safeguard public health. Page 12 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 5. STRATEGIC GOALS, OBJECTNES AND ACTIVITIES 5. 1. STRATEGIC GOALS From the SWOT and PESTEL analyses, as well as gaps identified in the WHO benchmarking and the QMS assessment reports, the following strategic goals or broad objectives are identified to be worked on the next five years to achieve mandate, vision and mission of the MCA. • Establish an effective and efficient medicines and related products regulatory system • Mobi lize technical and financial resources for the implementation of regulatory functions • Set up a functioning Quality Control Laboratory to support regulatory activities • Set up a Quality Management System (QMS) and undertake Operational Research activities to support regu latory functions • Develop and Implement an effective Information Management System • Promote Partnership and Cooperation.

5.2. SPECIFJC OBJECTIVES AND ACTIVITIES For each goal, specific objectives are set, which are measurable, and activities to achjeve the objectives indicated as below. Time lines are set for each of the activities and this is used to design an implementation framework.

5.2.1 GOAL 1 Establish an effective and efficient medicines and related products regulatory system. Specific objective 1 • Recruit, develop and maintain adequate Human Resource (HR) Capacity Activities o Identify the HR needs of the Agency and develop an HR plan o Recruit and retain key and relevant staff o [dentify training needs and develop training plan S pecific Obj ective 2 • Develop and provide appropriate regulatory tools for the efficient operations of MCA Activities o Identify and prepare initial drafts of required guidelines, forms, policies, manuals & SOPs based on best practices o Organize stakeholder retreats to validate the tools o Print and disseminate the tools o Monitor and evaluate use of the regulatory tools S pecific Obj ecti ve 3 • Acquire adequate office infrastructure and facilities Page 13 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 Activities o Follow up application for official allocation of land for the MCA complex o Design a concept for a new MCA building complex o Construction of office complex and laboratory facility Specific Objective 4 • Provide and maintain adequate logistics and 1T infrastructure Activities o Procure the necessary office infrastructure o Acqu·ire necessary operational vehicles o Procure server, computers and other hardware, appropriate software and accessories Specific Objective 5 • Ensure transparency in the performance of all regulatory functions. Activities o Develop a communication plan o Periodically publish bulletins and newsletters electronically and print o Maintain an up to date website o Develop and maintain internal and external communication systems Specific Objective 6 • Ensure that there is a results-based monitoring and evaluation system Activities o Develop M&E plan o Conduct regular monitoring and evaluation o Write and d issem inate reports

5.2.2 GOAL 2 Mobilize technical and financial resources for the implementation of Regulatory Functions Specific Objective l • Set up and implement a product registration & evaluation system Activities o Source, procure and install a medicines and related products registration software o Set up an archival and retrieval system for product dossiers. o Organize dossier evaluation retreats o Develop, publish and disseminate product registers o Organize training for manufacturers and importers on registration guidelines and dossier submission rules . o Train assessors on the new ECOWAS CTD format Page 14 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 Specific objective 2 • Set up and implement an Inspectorate System Activities o Conduct Post Marketing Surveillance (PMS) activities to clean market of illegal sale of medicines o Strengthen system for import and export control o Develop and sign MOU with C ustoms on import and expo11 control o Inspect premises including ware ho uses of Central Medical Stores, NGOs, and Importers Specific objective 3 • Strengthen the Pharmacovigilance (PY) systems Activities o Review and implement the existing PY plan o Review and update existing PY guidelines and tools o Set up and operationalize the Medicines Safety Expe11 Committee o Sensitize and train public and private health professionals on PY o Tra in and motivate PY contact persons to encourage reporting o Become full member of the WHO Collaborative Centre (Uppsala MonitoJing Centre) Specific objective 4 • Strengthen control and oversight of Clinical Trials (CT) Activities o Create a CT repository o Adapt A YAREF guidelines for control of clinical trials o Conduct Good Clinical Practice (GCP) Inspection o Train staff on Clinical Trial Application evaluation and GCP Specific objective 5 • License the appropriate facilities Activities 0 o License manufacturers, Impo11ers and warehouses/ storage facilities o Organize training for organizations involved in manufacture, importation, warehousing/ storage

5.2.3 GOAL 3 Set up a functioning Quality Control Laboratory to support regulatory activities Strategic Objective 1 • Acquire premises and logistics for the establishment of Medicines Quality Control Laboratory Page 15 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 Activities o Design a layout for QC Laboratory o Construct QC Laboratory complex o Identify and list equipment consumables needs o Procure, install and qualify the equipment Strategic objective 2 • Build Laboratory HR capacity Activity o Identi fy lab HR needs, recruit, train and retain Strategic objective 3 • Deve lop a Laboratory Information Management System Activities o Deve lop and implement Lab Quality Manual, SOPs, validation processes and Recording systems o Procure an appropriate Laboratory Information Management System

5.2.4 GOAL 4 Set up a Quality Management System (QMS) and undertake Operational Research activities to s upport regulatory functions Specific Obj ectives 1 • Develop a QMS plan towards ISO 900l:2015 Activities o Develop relevant SOPs for implementation of QMS o Train staff Oil QMS implementation o Implement the QMS in all departments o Develop a roadmap towards implementation and maintaining of QMS Specific Obj ective 2 • Establish a QMS for ISO 9001:2015 Activities o Implement roadmap and seek certification for ISO 9001:2015 o Conduct internal audits of the state of implementation of the QMS o External audit of the system fo r purposes of accreditation/ certifications o Recmit a consultant to support tbe MCA to establish a Quality Management System Specific Objective 3 • Deve lop and Implement appropriate systems for information and documentation management Activities Page 16 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 o Identify and procure appropriate software o Train staff and end users on the software o Develop a data protection policy, SOP and systems for QMS Specific objective 4 • Conduct research into medicines importation, d istribution and usage patterns Activities o Conduct research on antibiotic and controlled medicines use patterns o Study the types and forms of medicines imported o Conduct a survey on substandard and falsified medicines on the Gambian market 5.2.S GOAL 5 Develop andl Implement an effective Information Management System Specific Objecti ve l • Develop and maintain a management information systems Activities o Recruit consultant to develop computerized Information Management System and train staff on its use o Set up an intranet for internal communications o Review and constantly update information on the website o Set up software application for interaction with stakeholders Specific Objective 2 • Keep healthcare professionals and other stakeholders informed about product quality, safety and efficacy issues Activities o Issue "Dear Healthcare Professional Letters" to disseminate information o [ssue advertisers' announcements, disclaimers and drug alerts to educate the public o Conduct orientation session for stakeholders (NAMs, policy makers) S pecific Objective 3 • Educate the general public on the safe use of medicines and related products Activities o Organize orientation session for Senior journalist and Association of Health Journalists (AOHJ) members o Participate in TV and Radio talk shows and programmes and publish articles S pecific Objective 4 • Create Public Awareness on the existence & functions of the MCA Activities o Launch the MCA with adequate publicity Page 17 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 o Develop and implement an advocacy plan o Orientation/ Sensitization visits to Governors/ Chiefs in the Regions Specific Objective 5 • Develop SBCC strategy Activities o Conduct rapid assessment ofSBCC approaches for medicines regu lation o Develop messages based on the outcome of the assessment o Pre-test the messages o Validate the messages o Produce posters, fliers, hand-outs, billboards, leaflets and stickers, TV and radio spots, SBCC manuals and flip charts o Dissemination through TV, radio, print, website, community engagement (district authorities, MDTFs and IPC networks) and a hotline S.2.6GOAL 6 International collaboration and harmonization Specific Objective 1 • Participate in the ECOWAS and African Medicines Harmonization initiatives Activities o U ndertake a study tour at Ghana FDA and lead auditors training at SGS Ghana o Attend ECOWAS heads ofNMRAs meetings Specific Objective 2 • Participate in international conferences and exchanges on medicines and related products regulatiOIJJ Activities o Attend International Conference of Drug Regulatory Authorities and International Federation of Pharmacists o Attend AU NEPAD regional regulatory meetings o Attend World Health Assembly and other WHO facilitated meetings 6. GUIDING PRINCIPLES AND STRATEGY 6.l. GOOD REGULATORY PRACTICES In performing its functions, the Agency shall apply principles of Good Regulatory Practices, which include but are not limited to: • Ensuring transparency and accountability; • Promoting stakeholders' participation and building consensus; and • Observing a code of conduct and managing any potential conflict of interests. Page 18 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023

6.2. TECHN ICAL ADVISORY COMMJTTEES The MCA s hall perform its scientific functions through the use of Scientific and Technical Advisory Committees. This is premised on the fact that products regulated under the Medicines and Related Products Act 2014 are used for practice in various scientific and health professional areas. Disciplines like Clinical Trials, Pharmacovigilance, Veterinary medicines and related products call for such an approach.

6.3. INTERNATIONAL HARMONIZATION The Agency shall fully participate in international medicines and related products regulatory harmonization efforts at the WHO, AU NEPAD and WAHO levels. It will enter into MOUs with other regu latory agencies where necessary and participate in various cooperating arrangements within the world health environment. The MCA will consider l he scientific opinions expressed by other stringent NMRAs and international bodies such as ICH, WHO and OIE in its decis ions on medicines and related products quality, safety and efficacy.

6.4. DECENTRALIZATION Taking note of the fact that the functions of the Agency cannot all be perform,ed in Banjul, MCA will deploy staff at strategic locations and other Health regions over the next five years. In the meantime, MOU will be established with regional health administrations and also with Customs for the control of the ports of entry. Training will be provided for s taff of other agencies approved to perform some of the functions of the MCA on its behalf.

6.5. HUMAN RESOURCE MANAGEMENT Staff recruitment will be through advertisements and interviews. The existing staff shall be given first preference and offered permanent placement in accordance with their levels of competence. In terms of staff capacity buildings, short, medium- and long-term strategies will be employed. In the short tenn, the MCA w ill: o Engage consultants to conduct training workshops for staff 011 Dossier Evaluation, Inspection and the relevant WHO Good Practices such as Good Storage and Distribution Practices, etc. o Contact WHO, Global Fund and other bilateral or multilateral partners to assist in the establishment of a Level I Quality Control Laboratory to start with. o Contact international agencies such as WHO and WAHO for their schedule for training workshops and apply for staff to participate in programmes re levant to the MCA. In the medium te1m, the MCA will: o Collaborate w ith Medicines Regulatory Authorities (e.g. Ghana's FOB and Nigeria's NAFDAC) with regards to attachment of Staff to their agencies for training. o Identify opportunities for training attachments at the SWISSMEDTC, Health Canada, Indones ian and Malaysian Medicines Regulatory Agency amongst others. Page 19 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 In the long tenn, the MCA w ill identify potential staff to be developed through appropriate post-graduate academic and professional training for senior positions within the MCA. These potential staff may pursue a Master's Degree or Membership and Fellowship in the following areas: o Pharmaceutical Analysis & Quality Control o Pharmaceutical Quality Assurance & GMP o Pharmaceutical Science & Management Studies o Pharmaceutical Services & Medicines Control o Pharmaceutical Microbiology o Financial Management o Medical Products Regulatory Affairs These courses are offered but not limited to Universities in Ghana, Nigeria, UK, Ireland and other professional academic institutions such as the West Africa Post Graduate College of Pharmacists

6.6. MONITORING AND EVALUATION The Strategic Plan shall be monitored through a results-oriented monitoring and evaluation scheme annually. This w ill fonn the bas is for operational plam1ing and for annual or midtenn review of objectives and strategies, activities and key performance indicators to achieve the overall goals of the MCA. 7. ORGANIZATIONAL CULTURE AND ETHICS In order to discharge its duties effectively, the MCA shall function within a corporate cultural environment that safeguards its independence of action, integrity, effectiveness and impartiality. Procedures would be laid down giving the mechanism by wl1ich employees of the Agency are appointed an.d the security of their tenure of service guaranteed. The conditions of service, remuneration and working arrangements will be such that vested interests cannot exert any undue influence over staff or others working for the Agency. By the nature and operations of the MCA staff are supposed to abide by the followi ng: • Dressing appropriately when on duty • Not divulging information (Need-To-Know Principle) • Ensure the confidentiality of sensitive data • To observe the oath of secrecy • Key technical staff must be well infonned on issues relating to medicines and related products • Staff must be courteous • Staff must be faithful , sincere and of high integrity • Staff should not be involved in any activity that is liable to create a conflict of interest. • Ready to work outside the normal working hours • Staff should not overly expose themselves to the public Page 20 of 24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 • All categories of staff should not grant interviews without authorisation 8. GOVERNANCE STRUCTURE The MCA shall be made up of the following Departments: • Office of the Executive Director; • Finance and Administration; • Quality Control Laborato1y; • Inspection, Post-marketing Surveillance and Enforcement; • Medicines Safety Monitoring (Pharmacovigi lance) and Clinical Trials; • Medicines and Related Products Evaluation and Registration; The functions performed by the Departments may be organized under various Units for the efficient administration of the organisation. The Organogram of the MCA is attached as Annex I.

8.1. GOVERNING BOARD The Governing Board shall have twelve (12) members to be appointed by the President of the Republic of The Gambia. The Agency s hall be governed by a Board consisting of:- (a) A Chairperson; (b) The Permanent Secretary of the Ministry; (c) A representative of the Medical and Dental Association; (d) The Director General of the National Drug Enforcement Agency; (e) The President of the Pharmaceutical Society of Gambia; (t) The Registrar of the Pharmacist Counci l; (g) The Director of National Pharmaceutical Services; (h) A representative of the Veterinary Practitioners Association; (i) A representative of the Consumer association; (j) A representative of the Herbal Practitioners Association; (k) A legal practitioner from the Attorney General Chambers not below the rank of a Senior State Counsel; and (I) The Executive Director of the Agency, who shall be the Secretary to the Board. The members of the Board other than the ex officio members shall be appointed by the President after consultation with the Public Service Commission. The members of the Board other than an ex-officio member shal I hold office for a period of three years renewable once. A member of the Board may at any time resign from office in writing addressed to the Minister of Health. The Board shall ensure the proper and effective performance of the functions of the Agency. The Governing Board shall have the powers and duties to: Page 21 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 • Approve regulations for implementation of the Act; • Approve the Strategic Plan of the Agency; • Approve the annual work plan and budget of the Agency; • Review the quarterly reports presented by the Executive Director; • Monitor and evaluate implementation of the Act; • Approve the individuals recommended to be Directors by the Executive Director; • Establ ish committees whenever it deems necessary. 8,2, MANAGEMENT The Executive Director, Deputy Executive Director and the Directors of Departments shall constitute the strategic or top management team of the MCA. The general management staff of the MCA shall be made up of the Executive Director, Deputy Executive Director and the Directors of the various Departments and Heads of U nits. The functions for the vari ous officers and departments are as described below

8.2.1 EXECUTIVE DI RECTOR The Office ,o f the Executive Director shall house the Legal Officer, Internal Auditor, Procurement Officer, Quality Systems Manager, and Communication and IT Officer. There will be an administrative Assistance to assist in the day to day management of the office. Functions of the Executive Director shall be as follows among others: o The Executive Director shall be the administrative and teclmical head of the Agency andl shall direct and administer the day to day activities of the Agency. o Recommend senior staff for appointment by the Governing Board o Oversee the preparation and implementation of the Strategic and Operational Plan of the Agency. o Develop and establish a Quality Management System for the efficient and effective management of the organization. o Exercise the functions and duties of the Agency. o Administer personnel of the Agency following the basic principles of The Gambia Labour legislation. o Prepare and submit to the Governing Board an annual Operational Plan and budget of the Agency and implement same upon approval. o Submit quarterly reports to the Governing Board. o Establish technical committees with the approval of the Governing Board. o Approve registrations for medicines and related products upon recommendation from the medicines evaluation committee. o Approve and issue appropriate licenses. o The Executive Director may delegate part of his/her functions to other employees of the Agency to the extent necessary for the efficient performance of its activities.

8.2.2 DEPUTY EXECUTIVE DIRECTOR The Deputy Executive Director shall among others; Page 22 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 o Act in the absence of the Executive Director o Report to the Executive Director and provide technical direction to the MCA to ensure its efficient operation. o Be required to provide basic training where necessary and on the job mentoring to staff in all the technical departments. o Facilitate and coordinate capacity building of personnel of organizations dealing w ith products regulated by the Agency o Support the Executive Director in identifying technical areas that need external consultancy services, develop TORs and assist in the processes leading to the procurement of such services.

8.2.3 DIRECTOR FINANCE AND ADMlNISTRA TION The Director of the Department of Finance and Administration shall report to the Executive Director and shall carry out the following functions to support the core regulatory activities of the Agency: o Coordinate the preparation of the annual operational budget of the Agency; o Ensure accountabi Iity of the resources of the Agency o PreiPare quarterly statement of Accounts for the attention of the Executi ve Director o Lead in the resource mobilization efforts of the Agency o Be in charge of the Human Resource management activities with the Agency o Be in charge of general administration duties including transport, maintenance, security and estates

8.2.4 DIRECTOR QUALITY CONTROL AND ANALYSIS The Director of the Quality Control Laboratory shall report to the Executive Director and be responsible for the following functions: o Laboratory management; o Pre- and post-registration analysis of products regulated by the Agency; o Issue certificate of analysis for all products tested; o Development, review and validation of analytical methods; o Research into product quality trends.

8.2.5 DIRECTOR LICENSING, POST-MARKETING SURVEILLANCE, INSPECTION AND ENFORCEMENT The Director of the Department of Licensing, Inspection, Post-marketing Surveillance and Enforcement shall report to the Executive Director through the Deputy Executive Director and shall be responsible for the following functions: o Pre-licensing and post-licensing inspections of premises and organisati ons involved in manufacturing, import, export, distribution, sale or supply of products regulated by the Agency; o Routine inspection of medical stores, warehouses and other storage facilities; o Post-marketing surveillance activities; Page 23 of24 MCA 5-YEAR STRATEGIC PLAN 2019-2023 o Port of Entry inspections and sampling of products for import and export regulated by the Agency; o Enforcement of quality assurance systems in organisations dealing with products regulated by the Agency; o Collection of data on imports and exports of products regu lated by the Agency; o Coordinate research activities of the Agency o Liaise with the Drug Law Enforcement Agency on issues relating to Narcotics and Psychotropic medicines; o Supervise safe disposal of products regulated by the Agency; o Liaise with the National Environmental Agency on issues relating to manufacturing andl disposal of products regu lated by the MCA.

8.2.6 DIRECTOR CLINICAL TRIALS AND PHARMACOVIGILANCE The Director of the Department of Medicines Safety Monitoring (Pharmacovigilance) and Clinical Tria]s shall report to the Executive Director through the Deputy Executive Director and shall be responsible for the following functions: o Conduct Pharmacovigilance (safety monitoring) of medicines reguJated by the Agency; o Coordinate with other Agencies on the monitoring of Adverse Events after Immunization; o Be responsible for Vaccines control and regu lation of Blood and blood products; o Be respons ible for Lot Release of Biological products o Receive and evaluate applications for Clinical Trials; o Follow up on Clinical Trials to ensure compliance with Good Clinical Practice including Good Clinical Laboratory Practice.

8.2.7 DIRECTOR EVALUATION AND REGISTRATION The Director of the Department of Medicines and Related Products Evaluation and Registration shall report to the Executive Director through the Deputy Executive Director and shall be respons ible for the following functions: o Receiving of applications for registration of products regulated by the Agency including dossiers and samples; o Evaluation of dossiers and submission of samples for QC analysis; o Liaise with stakeholders in the C lassification of medicines and related products; o Creation and maintenance of product registers; o Review of labelling and promotional information; o Receipt and processing of applications for advertisements of products regulated by the Agency; o Dissemination of current product information and alerts; o Review of standards and specifications; o Receive and evaluate applications for import and export permits for products regulated by the Agency. Page 24 of24