Regulatory Preparedness and Mitigation Strategy for Emergency Health Threats

1. Introduction ...................................................................................................................................... 1

2. Scope................................................................................................................................................. 2

3. Objectives ......................................................................................................................................... 2 3.1. General objective ....................................................................................................................... 2 3.2. Specific objectives ..................................................................................................................... 2

4. Situational analysis .......................................................................................................................... 4

5. Stakeholders analysis ....................................................................................................................... 5

6. Preparedness prior to emergency health threat .............................................................................. 8

7. Triggers and response to health threat ............................................................................................ 9

8. Operational interventions .............................................................................................................. 11 8.1. Strengthen assessment on shortage of medical products and mitigate shortages ................ 11 8.2. Protect patients from substandard and falsified medical products ....................................... 12 8.3. Facilitate to accelerate priority research and innovation ....................................................... 13 8.4. Pharmacovigilance aspects...................................................................................................... 14 8.5. Develop legal and guidance documents ................................................................................. 14 8.6. Communication and information sharing ............................................................................... 15

9. Roles and Responsibilities ............................................................................................................. 16

10. Post health threat/crisis assessment ............................................................................................. 17

11. Financial and logistics arrangements........................................................................................... 18

12. Monitoring and Evaluation .......................................................................................................... 19 References ........................................................................................................................................... 21 i Acronyms AMA Africa Medicine Agency ACDC African Centre for Disease Control and Prevention EFDA Ethiopian Food and Drug Authority EMA European Medicine Agency EPHI Ethiopian Public Health Institute ESC Emergency Steering Committee ETF Enforcement Task Force EUA Emergency Use Authorization ICH International Council for Harmonization IGAD Intergovernmental Authority on Development MAH Market Authorization Holders MHRA Medicines & Healthcare products Regulatory Agency MOH Ministry of Health NMRAs National Medicine Regulatory Authorities PSUR Product Safety Update Re port SEC Standing Emergency Committee TA Technical assistance TGA Therapeutics and Goods Administration USFDA, U.S. Food and Drug Administration WHO World Health Organization ii

1. Introduction From the past and current experiences, emergency public health threats including coronavirus (COVID-19) are spreading with alarming rate which affects the stability of the global medical products supply chains. For the purposes of this document, the term “emergency health threat” refers to cross border health threats and national health threats in which the government believed and announced to be an emergency threat for the country and means a hazard of biological, chemical, environmental or unknown origin which is likely to spread across the nation and may cause a potential severe risk to public health necessitating a coordinated action at national level. Public health threat is a true test of the global medical products supply chain, and it is urgent that all players including national health regulatory authorities take appropriate steps to improve access to quality assured medical products and protect the safety of patients and the public. Today, domestic and global public health preparedness and response benefit from improved products, innovation, responsive manufacturing, and broader surveillance. However, much remains to be done as these critical efforts must be sustained. Scientific progresses in the last decades compel not only to articulate what is possible but also to identify what is needed to truly transform our pandemic preparedness. Research, innovation and new approaches should be considered to augment planning and responses. During pandemic/epidemic situation, illegal manufacturing, importation and distribution of medical products is a challenge. Various actors might take the opportunity of gaps in product availability and repeated shortages to proliferate illegal practices that could endanger public safety. The public health emergencies might also exacerbate the ongoing problems of substandard and falsified medical products. Moreover, lack of medical products including medical supplies and personal protective equipment might lead to an increased rate of infections and poor control of the pandemics/epidemics. Under the leadership of Ministry of Health (MoH), the Ethiopian Public Health Institute (EPHI) is responsible for the overall management and coordination of public health emergencies. The Ethiopian Food and Drug Authority (EFDA) is mandated to lead regulatory services which contribute for the success of critical public health decisions taken by the government. In addition, 1 EFDA plays an important role in streamlining coordination of scientific regulatory matters across the country including expedited approval of research and innovation related to product development, clinical trials, manufacturing and marketing authorization of medical products. Apart from taking measures to facilitate innovation and research, EFDA will also have unique role in mitigating the challenges of shortage of medical products, ensuring safety of patients and protecting public health from falsified and substandard medical products. In addition, creating proper channel for information exchange during emergency situation is important. Despite uncertainty in future epidemic/pandemic emergency health threats, developing and implementing concerted set of strategies will be critical to ensure prompt and flexible responses. Therefore, this strategy is developed to guide the roles and actions of the authority as part of the overall government efforts in dealing with emergency public health threats.

2. Scope This strategy focuses on dealing with emerging health threats such as coronavirus, ebola and others that could be caused by biological, chemical, environmental and other unknown triggers. The strategy is meant to provide guidance on regulatory interventions during public health emergencies. This strategy is not intended to health threats triggered by product related defects, which should be handled by product risk management plan that could deal with product specific incidents.

3. Objectives 3.1. General objective The strategy aims to ensure sustained access to innovative, safe, quality assured and effective medical products through mitigating medical products shortage during public health emergency situations. 3.2. Specific objectives  Initiate and coordinate scientific research and regulatory innovations involving relevant parties within and outside of Ethiopia during emergency situations. 2  Strengthen and coordinate authorization, surveillance and post-authorization follow-up of medicinal products relevant to emergency health response (e.g. vaccines and antivirals), medical devices (e.g. medical masks, shield, mechanical ventilators) and sanitizers (e.g. alcohol based, iodine based).  Provide special attention towards monitoring and authorization of clinical trials involving conventional and herbal products intended for the emergency situations.  Expedite the regulatory processes and introduce regulatory flexibilities during public health emergency for Emergency Use Authorization (EUA) so as to alleviate product shortages.  Detect, prevent and respond to substandard and falsified medical products circulating in the market taking advantage of shortages during public health emergencies.  Effectively communicate relevant information on timely basis to healthcare professionals, patients, general public and other relevant stakeholders.  As required, communicate, harmonize and coordinate with international and regional organizations such as WHO, EMA, ICH, AMA, etc and National Medicine Regulatory Agencies (NMRAs) including USFDA, TGA, MHRA, etc. to benefit from and contribute to global and regional efforts in response to public health emergencies; to expedite authorization of new and/or innovative products as part of efforts to improve access to available treatment options to the Ethiopian people during public health emergencies.  Ensure that EFDA have the appropriate tools and institutional framework for co- coordinated action for management of crises due to emergency public health threat 3

4. Situational analysis For the preparation of the emergency public health threat strategy, SWOT analysis was done to properly identify and determine factors that influence the working condition of the authority during public health emergency situation. The SWOT analysis are broadly divided into internal factors (Strengths & Weaknesses) and external factors (Opportunities & Threats) (Table 1). Table 1: SWOT Analysis Strengths Weaknesses • Commitment of EFDA top management • Absence of strategic roadmap for preparedness, • Political commitment of the government mitigation and response of public health • Improved flexibility of regulatory requirements emergency threat and timely responses • Inadequate approach on EUA processes of • Better and improved reporting and data medical products availability • Limited preparedness to tackle public health • Aavailability of directives and guidelines for emergency Emergency Use Authorization (EUA) • Poor coordination with some government • Establishment of national task forces organizations • Integrated inspection and surveillances • Lack of robust regulatory system that addresses • Availability of international partners to support public health emergency threat the Authority • Weak data storage, access to and use of quality information for decision making • Absence of early warning system of shortage of medical products • Lack of technology to detect, prevent and respond adulterated products, substandard and falsified health products Opportunities Threats • Presence of scientifically proven and globally • Emergence and re-emergence of disease accepted health products and technologies epidemics/pandemics • Advancements in technology both globally and • Proliferation of and/or weakly controlled illegal locally activities • Availability of information exchange platforms • Existence of porous borders in the country • High political commitment during health • Weak regulatory infrastructures both at regions emergencies and branch offices such as laboratories and ICT • Political instability hindering regulatory oversight • Limited resources 4

5. Stakeholders analysis Stakeholders are key players in the regulatory activities and their analysis is crucial to the success of the implementation of this strategy. Depending on the nature of the public health threat, different organization will be involved in the interventions. It is important to take into account the needs and interests of those who have a ‘stake’ in the regulatory sector. The stakeholder analysis done for this strategy is presented in Table 2 below. Table 2: The stakeholders’ analysis Stakeholders Behaviours we desire Their needs Resistance issues Institutional response  Community  Participation,  Access to up-to-date  Dissatisfaction  Community mobilization, engagement, Ownership and reliable  Opting for ensure participation and information, unsafe  Ensure sustained access  Healthy life style empowerment, alternatives to quality and safe  quality and safe  Mistrust medical products medical products  Underutilizatio  provide up-to-date, n reliable and proper information  Parliaments,  Approval of Policies  Proper implementation  Administrative  Put in place strong M&E Prime proclamations of laws, policies etc. measures system and Minister’s regulations etc.,  Information exchange  Organizational comprehensive capacity Office,  Resource allocation  Sustained access to restructuring building mechanisms Council of  Implementation follow- quality and safe  Influence on  Proper execution of Ministers, ups and feedbacks products to the public budget authority and Regional  Leadership support  Quick response to allocation responsibility Governments  Political commitment emergencies  Lack of  Corrective actions based  Plans & reports political on feedbacks commitment  Provide proper information  Ministry of  Leadership support  Proper plans and  Fragmentation  In place regulatory Health and its  Integrated regulatory reports  Dissatisfaction flexibility and efficient specialized activities  Transparency and approvals agencies,  Technical and financial flexibility of regulatory  Information exchange Regional support activities  Strong monitoring and Health  Support in enforcement  Efficient approval of evaluation of Bureaus activities import permit and port performance system  Provide proper clearance of medical  Develop regulatory information and comply products capacity for emergency 5 Stakeholders Behaviours we desire Their needs Resistance issues Institutional response with requirements for  Information exchange response importation of products  Information exchange  Line  Collaboration and  Technical support  Fragmentation  Integrated collaboration Ministries participation  Up-to-date and reliable  Dissatisfaction  Transparency and (Trade and  Consider health in all information exchange  Considering provision of up-to-date industry, policies and strategies  Collaboration medical information on Custom, etc.)  Information exchange  Integrated operational products regulatory measures  Enforcement of laws plan regulation as  Joint operational work  Control illegal medical  Access to standards low priority plan on illegal control products  Evidences activities  Advocacy and joint meetings  Use of standards and evidences  Law  Support and  Legal framework  Fragmentation  Integrated collaboration enforcement collaboration in  Awareness on medical  Dissatisfaction  Provision of up-to-date bodies enforcing laws products laws  Considering information on (Justice,  Technical support  Technical support medical regulatory activities Court, Police  Integrated work on  Clear and concrete products  Joint operational work etc) illegal trade evidences regulation as plan on illegal control  Support in preparing  Current and reliable low priority activities legal frameworks and information exchange  Advocacy and joint legal advices  Joint operational work meetings plan  Providing clear and  Trust concrete evidences  Academia  Technical assistances  Collaboration  Mistrust  Create transparence and  Evidence generation  Engagement and  Fragmentation collaboration modalities participation  Dissatisfaction  Create conducive  Information exchange environment for engagement and participation  Use of evidences generated  Properly utilize their TAs  Provide and take up-to- date information  Manufactures  Abide with available  Collaboration  Breaching laws  Ensuring good , Importer laws  Efficient and timely  Mistrust governance and efficient and  Participation regulatory services  Dissatisfaction service delivery 6 Stakeholders Behaviours we desire Their needs Resistance issues Institutional response wholesaler  avail quality products  Transparency  Continuous provision of and services  Fast response awareness on laws  Information exchange  Awareness on legal  Provision of feedback frameworks and support  Enabling environment  Create transparence and for their engagement collaboration modalities  Technical support  Dialogue  Information exchange  International  Technical assistances  Collaboration  Fragmentation  Create transparence and organizations  Evidence generation  Engagement and  Dissatisfaction collaboration modalities (WHO,  Information exchange participation  Properly utilize their TAs Interpol,  Alert system  Information exchange  Provide and take up-to- AMA, EMA, date information AMA, etc)  Development  Harmonized and aligned  Financial system  Fragmentation  Government leadership Partners  Participation accountable and  Inefficiencies  Transparency  More financing transparent  Efficient resource use  Technical support  Involved in planning,  Build financial and M&E management capacity  Collaboration and  Collaboration and engagement engagement  Provide and take up-to- date information  NGOs, CSOs,  Harmonization &  Involvement and  Dissatisfaction  Collaboration, and alignment participation  Fragmentation Transparency, Advocacy professional  Participation, resource &  Technical support  Scale down  Capacity building associations TA  Mistrust  Information exchange  Promote code of  Use of technical support conducts  Aware the public and member of the societies  Media  Collaborate on provision  Up-to-date and reliable  Dissatisfaction  Provide up-to-date and of right information to information  Fragmentation reliable information the public about the  Transparency and  Mistrust  Strengthen collaboration emergency health threat participation  Dissemination and integrated works mitigation and response of untruth  Create transparent and related activities information participatory platform for medias 7

6. Preparedness prior to emergency health threat The Authority will undertake the following actions as part of the routine preparedness to ensure adequate readiness to deal with an emergency public health threat.  Regular interactions with vaccine/antimicrobials/antivirals experts and regulatory network with academia, research institutes and relevant stakeholders and partners;  Regular discussions with local manufacturers and suppliers of medical products.  Regular interaction with EPHI through early warning and response system set up by EPHI. There should be notification and information sharing of health measures planned or undertaken against serious cross border health threats;  Regular interactions and information sharing with international organizations such as WHO, EMA, AMA and other national regulatory agencies.  Regular interactions and information sharing with the African union, African Centre for Disease Control and Prevention (ACDC) & Intergovernmental Authority on Development (IGAD).  Conduct regular analysis to compare recently imported and locally manufactured products by utilizing trends to forecast imminent shortages and identify alternative solutions.  Create regulatory flexibility that suits public health emergency mitigation and response  Prepare and make ready necessary legislative documents that facilitate decisions for emergency use authorization of medical products during emergency situations  Arrange logistic and supply arrangements including financial and other resources.  Establish structure within the Authority that deal with emergency and crisis management.  Harmonize important regulatory requirements with other NMRAs to facilitate speedy access to existing, new and innovative products 8

7. Triggers and response to health threat When the Ethiopian government declares an emergency public health threat and needs serious response, the Authority will commence different level of response mechanisms and level of activation of the emergency. In addition, EFDA will establish different task forces in response to the health threat (Table 3), which will be translated into coordination of rapid-response teams in the emergency. Those rapid-response teams with members from research institutions, academia, regions, police and professional association should be trained and equipped with appropriate skills and resources. The task forces will be involved in preparations and dissemination of facilitated legislative tools, establishment of systems to mitigate shortages of medical products, combat substandard and falsified medical products, surveillance of market, facilitation and support for innovation and research, and implementation of clear communication mechanisms. Furthermore, the EFDA technical and administrative directorates will integrate preparedness and response issues in their day-to-day activities as per the recommendations from the emergency taskforces. 9 Table 3: Level of emergency and teams established during the emergency health threat Level of SN Teams to be Established Experts to be Involved Activities Emergency

1. Level 1 Emergency Steering Director General (DG), deputy Detail roles (outbreaks Committee (ESC) director General (DDG), Directors of of reported) technical directorates, Regional committees Health regulatory bodies, Legal are department and communication explained in Standing Emergency Directors of technical directorates, section (9) Committee (SEC) EFDA advisors, representative of of this academia, association, and research strategy institutions Enforcement Task Force Inspection Directorate, Surveillance (ETF) Directorate, Inspection department of Regions, Police

2. Level 2 Emergency Steering As stated in level one emergency (epidemic/ Committee (ESC) PHEIC Standing Emergency As stated in level one emergency declared) Committee (SEC) Enforcement Task Force(ETF) As stated in level one emergency

3. Level 3 Emergency Steering As stated in level one emergency (Pandemic Committee (ESC) declared) Standing Emergency As stated in level one emergency Committee (SEC) Enforcement Task Force As stated in level one emergency (ETF) 10

8. Operational interventions To mitigate shortages of medical products, contain substandard and falsified medical products, facilitate innovation and research, create flexible regulatory procedures, prompt information exchange and other related regulatory activities during the emergency situation, EFDA will first identify potential problems, develop mitigation strategies and contingency plans to address them. The following sets of interventions will be done by the Authority to respond to public health emergencies. 8.1. Strengthen assessment on shortage of medical products and mitigate shortages The continued availability of essential medical products, during public health threat such as COVID-19, is of critical concern for the Authority. To help mitigate supply disruptions, EFDA shall setup system that enables the availability of the products. To mitigate this drastic problem, the authority shall consider the following activities. a. Use data to forecast shortages: EFDA will conduct immediate analysis to compare recently imported and locally manufactured products with historical utilization trends to predict imminent shortages and establish early warning systems to identify imminent shortages. In Addition, it will identify alternative sources for medical products and consumables on shortage or most prone to shortages; and develop guidance for detection and notification of shortages of medical products, and require manufacturers to disclose supply disruptions. b. Review the risks for supply chain disruption for critically-needed medical products: Consider developing a supply chain vulnerability risk assessment that will model hypothetical situations for future disruptions. This should also be visible to all manufacturers, partners and suppliers in the government. c. Implement facilitated approach for medical products approval: The Authority will rely on stringent regulatory authorities approved products, and utilize waivers and related instruments to facilitate the availability of critically needed products not yet approved in Ethiopia. In addition, remove non-critical administrative requirements during the emergency situation. d. Engage compounding pharmacies and small-scale manufacturing institutions: to fill the gaps on the identified products, the Authority will encourage and support the existing compounding pharmacies, hospitals and those who have the potential to compound products 11 such as sanitizers, alcohols and other necessary products. In addition, small scale manufacturing institutions should come onboard. The Authority will support them to produce the most critical items needed. e. Lean on local medical equipment manufacturers: EFDA will link hospitals with local manufacturers of personal protective equipment such as gloves, masks and other medical devices such as respirators. In addition, EFDA will design strategies for special support packages to local manufacturers including fast track approval, support in repurposing of manufacturing activities, expediting testing and approval of their products etc. f. Establish systems and legislations to mitigate future shortages: EFDA will issue temporary directives and guidelines that create flexibility on the existing regulatory requirements. In addition, require manufacturers to submit information on manufacturer location, product details, batch size, current capacity, etc; establish mandatory reporting of shortages by industry, controlled importation of foreign-approved products, and fast-track review for shortage-prone products and develop a categorization system for shortage-prone products. In addition, incentivize manufacturing of shortage-prone medical products. g. Aware the public and health professionals to conserve the limited medical products and use maximally. 8.2. Protect patients from substandard and falsified medical products During public health emergencies, illegal manufacturing, importation and distribution of medical products is a challenge. Various actors might take the opportunity of gaps in product availability and repeated shortages to proliferate illegal practices that could endanger public safety. This is double burden to the society and the government as well. Hence, the Authority shall in place special consideration to tackle substandard and falsified medical products circulation. To achieve this, EFDA will perform the following activities or interventions: a. Share product quality surveillance information: Develop systems to share registered products, inspection reports, product quality test results, and other data relevant to medical product quality with other regulatory agencies. b. Implement risk-based quality surveillance: Potential therapeutic options for emerging public health threat e.g. COVID-19 may become a new focus for falsified medicines and substandard manufacturing and should be prioritized for quality surveillance. For 12 instance, with respect to COVI-19, chloroquine, hydroxychloroquine, azithromycin, lopinavir/ritonavir, ribavirin, and corticosteroids can be considered. In addition, EFDA will monitor the active pharmaceutical ingredients (APIs) and inactive ingredients (excipients) during the situation. c. Leverage technology to remotely monitor medical product quality: EFDA will use strategies including monitoring and analyzing multiple data points such as social media, announcements though main stream media to report any suspicious activities regarding manufacturing, importation, distribution, usage of health products and technologies claimed for public health emergencies, patient reporting, professional reporting, citizen reporting, WHO data, and imported data. During pandemics, since inspectors may unable to travel, and quality testing may not be conducted on timely manner, remote surveillance capabilities will help protect the public from poor-quality medical products. 8.3. Facilitate to accelerate priority research and innovation At times of emergency situations, urgent questions and uncertainties may come into front. Every one affected by the incidence seeks countermeasures including diagnostics, vaccines, and therapeutics that could be developed to detect, mitigate and provide appropriate response to the health threat. For example, to stop spreading of COVID-19, improve treatment outcomes; strengthen the ability to detect the virus, increase access to health commodities and control illegal traders and abusers etc are important. From a regulatory perspective, the Authority needs to facilitate clinical trials approvals and other innovations in the context of an emerging health threats considering the clinical trial and innovation principles. Clinical trial design and innovation may differ substantially depending on the health threat and type of products. EFDA will develop and formalize through relevant administrative approval processes, an expedited ethical review pathway and expedited regulatory review pathways for clinical trials. The Authority should also create and facilitate clear interaction/consultation with Ministry of Health, Ministry of Innovation and Technology, academia and other relevant stakeholders. Without unnecessarily compromising patient safety and public benefit, maximum shortest realistic priority shall be made to encourage research and innovations. EFDA will support and 13 accelerate health research, innovation, and knowledge sharing on all matters mandated to regulate including medicines, medical devices and other related procedures and practices. Efficient strategies to expedite review and approval pathways include parallel/simultaneous ethical and regulatory review, close communication between ethical and regulatory groups and non-hesitant decision making. In addition, develop guidance on regulatory preparedness for EUA and ethical principles during emergency health threats. The Authority shall have the regulatory tools to use new health products and technologies during health emergencies. 8.4. Pharmacovigilance aspects Pharmacovigilance activities in the situation of an emergency health threat should be enhanced, and tools and processes which could be used in these situations shall be in place. There should be proper benefit-risk communication to public and healthcare facilities/personnel of new or existing products used for emergency public health threat. The main elements to be considered during emergency situation are indicated below: • Activities related to signal detection and management should be enhanced and/or accelerated during emergency or mass use of new products or during mass use of previously authorised products such as campaign vaccinations and mass drug administrations. At this time, Incident Management task force has to be formed and work closely with appropriate emergency public health threat management institutions. • When the Marketing Authorisation Holder (MAH) becomes aware of an Emerging Safety Issues (ESI) from any source, they should notify it in writing to the authority. Emerging Safety Issues (ESIs) are safety issues considered by a MAH to require urgent attention by the authority because of the potential major impact on the risk-benefit balance of the medicinal product and/or on patients’ or public health, and the potential need for prompt regulatory action and communication to patients and healthcare professionals. • The rapid exchange of information on safety issues between the authority, professionals and relevant stakeholders should take place. 8.5. Develop legal and guidance documents The Authority should work closely with MoH, other healthcare partners and stakeholders to rapidly identify where flexibilities in the regulation of medical products may be possible. In 14 response to this, EFDA shall issue legal and guiding documents for EUA that support industries, distributors, researchers and innovators, and other actors engaged in the healthcare products supply chain to provide a wider response to the health threats in Ethiopia. 8.6. Communication and information sharing EFDA should establish consistent and sustainable communication to the general public (e.g. press releases, interviews, social media, and printing media) in the event of any crisis, and coordination of such communication with partners and stakeholders to ensure coherent and consistent messages to the public. This communication includes elements specific to emergency health threats. In addition, there should be interactions and information exchange with international regulators and international organizations, e.g. USFDA, EMA, WHO. The Authority shall perform the following activities during emergency public health threats. • Communicate medical product shortages: EFDA should provide periodic communication to citizens on the shortages that have been identified and how they are being mitigated. • Provide information and alerts to the public, patient, health professionals and other relevant stakeholders on safety and quality of medical products related matters and measures taken. • Share updates on prevention and treatment options for public health threat like COVID-

19. The authority shall communicate to the public the current lack of effective prevention and treatment options for COVID-19, while at the same time informing the public about ongoing vaccine trials, provider/patient agreements to use experimental therapeutic options, and compassionate use of products currently undergoing regulatory review. • Capture treatment outcomes of any treatment: The Authority will encourage physicians, nurses, and pharmacists and other health professionals to report outcomes on use of any therapeutic products in COVID-19 patients and other future threats. Platform shall be established for health professionals to report to EFDA when encountered such cases. • Collaborate with existing regulatory networks and regional harmonization initiatives to share both confidential and public information expeditiously for timely decision making. • Collect, analyze, disseminate and monitor information. 15 Any form of information including press releases, media brief, interviews, social media, and printing media dissemination to public should be through Public Relation and Communication (PRC) department of the Authority. When higher officials and/or technical persons are needed, the PRC will facilitate the arrangement for its effective implementation of the event.

9. Roles and Responsibilities The following committees and expert groups will be designated at the time of public health emergency to deal with the health threats/crisis. The committees will have their own rules and regulation, and will also have detail plans. In addition to the roles and responsibilities provided, all actors involved in the implementation of this strategy will be accountable to the activities assigned to them. 9.1. Emergency Steering Committee (ESC) The Emergency Steering Committee is the highest strategic team for the threat which provides and follows high level consideration to the major scientific, regulatory and communication activities. The following activities will be done by ESC. • Lead the whole preparedness, mitigation and response to the threat and provide directions • Assign resources at the beginning of the health threat • Review and approve the detail plans of SEC and ETF • Take executive decisions in the interest of the public health • Coordinate the situation with other stakeholders • Upon delegation given by the management committee of the Authority, approve legal documents in response to the threat • Work in close liaison with available committees of the MoH and EPHI • Keep informed all other teams about high level status reports of the emergency threat • Ensure that the health threat plan is followed and that the operational activities during the health threat are conducted • Monitor weekly or daily performances of other committees • Reports to EFDA management and other committees at MoH and EPHI, when it is required 16 9.2. Standing Emergency Committee (SEC) • At the early phase (before formal declaration), act as an initial point of contact for interaction with external stakeholders and coordination within the network for the emergency threat • Regularly involved in the management of the activities related to the health threat • Synthesis scientific evidences and provide recommendations to ESC • Prepare position statements and, Q&A in response to the emergency health threat • Prepare legal and guidance documents • Provide advice to domestic manufacturers and innovators on developing medical products against the emergency health threat, e.g. vaccines, sanitizers, therapeutic products, ventilators and other health commodities • Reports to the emergency steering committee 9.3. Enforcement Task Force (ETF) • Coordinate with law enforcement bodies • Survey the market and issue regular enforcement activities • Monitor internet market and illegal traders • Perform activities based on the recommendation of the ESC and SEC • Contribute to product-related assessment and post-authorisation surveillance activities; • Will deliver assignments given by the higher committees • Reports to the Standing Emergency Committee

10. Post health threat/crisis assessment Following closure of the emergency health threat, it is important to take the opportunity to learn from the experience, i.e. to conduct “lessons learned” exercise. This should cover aspects of the health threat or crisis that were not handled well and may need to be changed, but should also describe what was done well and does not need to be changed. A forum to discuss these matters and identify ways of improving the Emergency Health Threat Strategy is to be established. As mentioned, in addition to the revision of the strategy, different improvements to different areas and procedures in particular legislations and internal infrastructures will be addresses. 17

11. Financial and logistics arrangements Inventory should be done initially to identify the available logistics and supplies, and financial requirements that help facilitate the preparedness and mitigation activities of the public health threats and available gaps. Mobilization activities should be done to fill identified gaps regarding logistics and supplies, and finance. This should be prepared as early as possible based on the expected number of cases, suspected patients and contacts; and demands for health products and technologies used for the public health emergency. The source of budget could be from the government budget allocated to normal activities and partners support. To do budget shift from the government allocated budget, procedures provided by the government should be followed. In addition, unless special condition and approval procedure is set, any procurement will be done in accordance with government procurement procedures. However, resource mobilization including financial and technical assistance from partners for such purposes will be sought. Furthermore, detailed operational plans with budget having detail costing will be developed with global, regional, and country level implementation partners consistent with the overall strategic framework and based on actual needs, gaps, and implementation capacity. 18

12. Monitoring and Evaluation Monitoring and evaluation is the key pillar of the preparedness, mitigation and response of Emergency Health Threat Strategy and will be used as a guide to monitor and evaluate the performance of the implementation. The monitoring and evaluation system includes techniques and processes that continuously collect, analyze and interpret data to know the appropriateness of the activities under process, achievements, performance gaps and provide up to date information for responsible body to take necessary corrective actions. Key performance indicators that monitor the performance of the implementation of the strategic preparedness, mitigation and response will be determined when such health threat has happened. 12.1. Report Plan Depending on the situation, the committees established will meet on regular basis and report to their respective upper level as per the report template provided by the authority. In addition to the higher management of the authority, the Standing Emergency Committee (SEC) will work in close contact with the committees of the MoH and EPHI. Though could be modified as the situation may be, the following reporting modalities and timelines will be followed (Table 4). Table 4: Reporting modality and timelines SN Established committee Reports to Timeframe

1. Emergency Steering Committee (ESC) EFDA management 15 days

2. Standing Emergency Committee (SEC) ESC Weekly

3. Enforcement Task Force (ETF) SEC Dailya and Weeklyb

4. Technical Directorates of EFDA ETF Dailya and Weeklyb Note: EFDA will report to MoH on timelines decided by the ministry a Main progress reports of the day and issues that need quick reposes b Summarized reports of activities performed during the week and issues to be resolved, if any 19 12.2. Data Sources At a minimum, the following source of data for M&E will be used:  Routine reports of Emergency Steering Committee (ESC), Standing Emergency Committee (SEC), Enforcement Task Force (ETF),  Routine reports of relevant directorates such as port of entry & exit, inspection, registration, surveillance and legal directorates.  Rapid assessments and research related to the emergency  Data generated from the government, international organizations and other countries 20 References

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