The Rapidly Evolving Regulatory Landscape in Africa

Transcription

1 The Rapidly Evolving Regulatory Landscape in Africa B. Dicky Akanmori Regional Advisor, Vaccine Regulation Immunization, Vaccines & Emergencies Cluster

2 What has changed? Prime targets for vaccine development Malaria, TB and HIV as remaining challenges for vaccine development. 14 million in need of immediate antiretroviral therapy Average treatment coverage inadequate (47% based on WHO 2010 eligibility criteria) Malaria is prime target for vaccine development Annually, 225 million cases occur globally with 781,000 Deaths. BCG has low and variable protective efficacy especially against pulmonary tuberculosis in adolescents and adults. 2

3 Outbreak Pathogens with no vaccines! Rift Valley Fever virus Ebola virus Chikungunya virus Marburg virus MERS coronavirus Pandemic influenza Venezuelian equine virus Crimean-Congo haemorrhagic fiver virus Enterovirus 71 Henda virus Monkeypox virus Nipah virus SARS coronavirus West Nile virus Some products in phase 1, others preclinical 3

4 Complexity of products, platforms and designs live sporozoites of Plasmodium falciparum (PfSPZ), harvested from facility-reared mosquitoes and used as vaccine Viral vectors Non-traditional designs (adaptive designs) Focus on adolescents Overlap of trials phases 1 and 2 complex adjuvants and immune-stimulants Human challenge studies - malaria 4

5 Other issues Lack of reliable correlates of protection Combination of complex and non-validated assays to measure protection (regulators often confused) Demand for shorter review and approval times Limited resources for NRAs as resources are diverted to network. National commitment 5

6 The response Networks of regulatory authorities AVAREF, AMRH, others Training Information sharing between African regulators and regulators of developers (Health Canada, USFDA, EMA) Innovations - Joint reviews of CTAs, joint GCP inspections and joint licensure (monovalent IPV) Early interaction between manufacturers and regulators Improved quality management systems of African NRAs Reliance on external experts for reviews 6

7 African Vaccine Regulatory Forum (AVAREF) INNOVATIVEW WAYS OF PROVIDING OVERSIGHT FOR CLINICAL TRIALS IN SUB- SAHARAN AFRICA National Regulatory Authority AND Ethics Committees Scope Regulation of Clinical Trials Support from USFDA, Health Canada, European Medicines Agency Vaccine Regulation of Medicines Common strategy PACTA Annual meetings Exchange of information on CTA approvals Guidelines and tools Information sharing and collaboration AVAREF Members: Botswana Niger Burkina Faso Nigeria Cameroon Rwanda Central African Rep Senegal DRC Sierra Leone Eq. Guinea South Africa Ghana Tanzaania Gabon Uganda Kenya Zambia Malawi Zimbabwe Mali The Gambia Mozambique

8 Regional Harmonization Initiatives African Medicines Regional Harmonization Based on economic blocs (East African Economic Community, Southern African Development C, Economic Community of West African States, UEMOA, CEMAC) African Medicines Agency Endorsed by African Ministers of Health.

9 Expectations of regional initiatives Platforms for capacity building Harmonization of procedures Improvement in efficiency Information sharing Sharing of expertise

10 Limitations of networks Regional harmonization not replacement for strong functional NRAs How to network the networks EAC (5 countries), ECOWAS (15 countries), SADC (<10 countries) How to ensure sustainability Slow implementation of agreed activities Duplication and non-optimal use of resources for capacity building Depletion of staff of NRAs to staff networks 10

11 Some Countries whose NRAs are undergoing changes Kenya Uganda Rwanda Tanzania South Africa Botswana Zambia 11

12 Some Changes at African NRAs Electronic submissions Timelines for reviews 2 to 6 months Mali approved Ebola Vaccine CTA in a week. Designation of staff to reviews Expert committees advising NRAs 12

13 13 Future perspectives Complex products will be required in the R&D of vaccines, especially against malaria, TB and HIV/AIDS. There will also new vaccine developers and products for clinical evaluation in resource-limited settings. Prioritization of products required to ensure that resources are applied to provision of regulatory support for products of high public health priority. Innovative designs to minimize costs through smaller sized clinical trials will become more common. Designs will also target more adolescents. Better facilities are required, especially for early phases of clinical trials to ensure participant safety..

14 Future perspectives Appropriate platforms for ethics and regulatory reviews and oversight in order to protect the study participants. Communication, collaboration and support for African regulators by those of countries where products are manufactured Revision of legal framework for regulatory authorities. Support of WHO and other partners in providing guidance and ensuring that international standards are upheld for the safety of participants. Use of clinical trials registries will ensure that trials are publicly available, thus promoting transparency Mounting public pressure for vaccines against outbreak diseases - Ebola 14

15 15 Thank you!