Challenges of Medicine Regulation in Africa

1. Challenges of Medicine Regulation in Africa Global Pharmaceutical Regulation MP Matsoso

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

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

4. Regulatory Gaps: A Global Picture 193 Member States: Developed 1/6 Developed regulatory systems 1/2 Varying levels of development & operational capacity 1/3 limited or no capacity Developing a Developing b Developing c1 LDC/CPA - a Developing c2 LDC/CPA - b

5. 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. 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. 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. Technical Package: Registration Submission of Application Product X Product development 1 2 Application Product X Authority A Authority B Registration Process Registration Process Technical package Decision Decision

9. 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. Opportunities: Harmonisation of Medicine regulation • Regulatory package based on WHO guidelines. Assess country and regional capacities and determine roles and functions. • Joint assessments, inspections, dossier evaluation and information exchange. • Twinning arrangements with more stringent authorities e.g. EMEA, FDA. Maximization of benefits of global initiatives, i.e. Prequalification • Harmonize standards and guidelines and medicines lists (paediatrics, reproductive health etc) • Strengthen management and administration of regional structures, promote good governance and practices • Regional Enforcement activities to fight counterfeits

11. Shared information repository on regulatory and pharmaceutical activities and data 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

12. 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. 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