1. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Challenges of Medicine Regulation in Africa Global Pharmaceutical Regulation MP Matsoso

2. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Evaluation & registration TECHNICAL ELEMENTS Standards Norms Specifications Guidelines Procedures Infrastructure Finance Human resources Policy, legislation, regulations STRUCTURES AND ADMINISTRATIVE ELEMENTS Licensing Manufacturing Import Wholesale Retail Dispensing Premises Practices Persons Generic drugs New drug molecules Clinical trial Inspection Manufacturing New drug molecules Clinical trial Quality control Physico-chemical Microbiological Pharmaceutical Information & Promotion control Safety & Efficacy surveillance District Drugs for human use Functions & Processes LEVEL Central State/province Community Dimensions of Drug Regulation

3. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Pre-marketing phase Post Marketing phase Market surveillance Market surveillance Inspections Market distribution Clinical trials Ethics, GLP;GMP,GCP) Clinical trials Ethics, GLP;GMP,GCP) Quality Safety Efficacy Product Evaluation Product Evaluation GMP compliance GMP compliance Licensing facility Licensing facility Laboratory testing Laboratory testing Dossier Licensing/Registration= evaluation process Applicants Dossier Marketing Authorization Complexity of Regulatory Processes Safety monitoring Safety monitoring Variations Approval

4. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Regulatory Gaps: A Global Picture Developed Developing a Developing c1 Developing b LDC/CPA - a LDC/CPA - b 1/6 Developed regulatory systems 1/2 Varying levels of development & operational capacity 1/3 limited or no capacity 193 Member States: Developing c2

5. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Regulatory Challenges Complexity of Regulatory Processes and requirements has increased Limited regulatory capacities in countries Regulatory delays and backlogs Lack of specific timelines by MRAs Lack of requirements that are publicly available (rapidly evolving technologies, new drug delivery and vaccine delivery technologies) Lack of access to appropriate technology

6. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Integration among regions: An approach Regional and subregional approaches and global initiatives are considered for: Pooling resources, to deal with capacity challenges, Reducing duplication of effort, redirecting resources Standardizing requirements Streamlining regulatory processes Legal mechanisms to jointly negotiate Promotion of good governance

7. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine The case for harmonisation Initiatives that are considered for pooling resources Global Initiatives : –WHO Prequalification (supports procurement, but has strong regulatory focus) –DCVRN (vaccine regulatory network of 9 countries established by WHO) –EU Article 58, Scientific Opinion for medicines exported from EU but not for sale in EU, partnership with WHO –FDA Tentative approval of PEPFAR linked products, confidentiality agreement with WHO –ICH GCG- Participation of some subregional blocs, SADC, ASEAN, PANDRA

8. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Technical Package: Registration Submission of Application Product X Authority A Authority B Product development Registration Process Decision Registration Process Decision Application Product X 1 2 Technical package

9. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Post Marketing: Redirecting resources –Scientific information after the authorization (variations) –Post marketing information on quality –Post marketing information on safety and efficacy –Continuous risk benefit assessment –Strengthened law enforcement capacity

10. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Opportunities: Harmonisation of Medicine regulation 1.Regulatory package based on WHO guidelines. Assess country and regional capacities and determine roles and functions. 2.Joint assessments, inspections, dossier evaluation and information exchange. 3.Twinning arrangements with more stringent authorities e.g. EMEA, FDA. Maximization of benefits of global initiatives, i.e. Prequalification 4.Harmonize standards and guidelines and medicines lists (paediatrics, reproductive health etc) 5.Strengthen management and administration of regional structures, promote good governance and practices 6.Regional Enforcement activities to fight counterfeits

11. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine SADC/WHO DRA 1 DRA 2 DRA 3 DRA 4 SADC/WHO DRA 1 DRA 3 DRA 2 Sharing basic information: a common data and file repository has been created for participating countries. Limited number of countries for registration package Adding scope and functionality: additional countries participate and make available selected national medicines registration data Shared information repository on regulatory and pharmaceutical activities and data Angola Botswana Democratic Republic of Congo Lesotho Malawi Madagascar Mauritius Mozambique Namibia South Africa Swaziland Tanzania Zambia Zimbabwe

12. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine CEMAC COMESA EAC ECOWAS SADC UEMOA Shared information repository & query system on national registration status of medicines. Connectivity between national registration systems Facilitating harmonization: countries participate in various subregional activities. Some have developed guidelines, subregional harmonisation plans. Subregional assessments give status of a country within a subregion

13. and Pharmaceuticals Health Technology Technical Cooperation for Essential Drugs and Traditional Medicine Integration among African countries Progress Some countries have removed barriers to trade (e.g. tariffs). May be good to advocate for removal of taxes and tariffs for essential medicines Interconnectivity in terms of transport links and telecommunication (ECOWAS, SADC,CEMAC, UEMOA) Common purpose and collective action Main support from WHO working with Partners Drawbacks Conflicts High disease burden Multiplicity of regional economic communities (duplication, overlaps, waste of scarce resources) Transport costs still too high Slow pace