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SADC HARMONISATION INITIATIVES

SADC HARMONISATION INITIATIVES. -. OUTLINE. INTRODUCTION BRIEF HISTORY OBJECTIVES GUIDELINES DEVELOPMENT FOR MEDICINES REGULATION PLAN OF ACTION TRAINING CHALLENGES. INTRODUCTION. Regulatory challenges and imperatives National Medicines Regulatory Authorities Legislative framework

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SADC HARMONISATION INITIATIVES

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  1. SADC HARMONISATION INITIATIVES -

  2. OUTLINE • INTRODUCTION • BRIEF HISTORY • OBJECTIVES • GUIDELINES DEVELOPMENT FOR MEDICINES REGULATION • PLAN OF ACTION • TRAINING • CHALLENGES

  3. INTRODUCTION • Regulatory challenges and imperatives • National Medicines Regulatory Authorities • Legislative framework • Technical guidelines and requirements • Human, physical and financial resources • Processes and systems

  4. ANGOLA BOTSWANA DEMOCRATIC REPUBLIC OF CONGO LESOTHO MALAWI MAURITIUS MADAGASCAR NAMIBIA SOUTH AFRICA SWAZILAND TANZANIA ZAMBIA ZIMBABWE SADC MEMBER COUNTRIES

  5. BACKGROUND • SADC Health Protocol for regional cooperation and integration • Protocol Implementation Plan • Priority areas: TB, Malaria and HIV and AIDS • Program on pharmaceuticals: regulation, availability and access

  6. OBJECTIVES • Promotion of access to essential medicines of quality, safety and efficacy by • Development of standards for the quality, safety and efficacy of medicines in the region • Establishment of a structure for harmonisation • Establishment of Centres of excellence

  7. GUIDELINES DEVELOPMENT • Discussion Forums • Representation • Allocation of responsibilities • Process and Progress

  8. LIST OF GUIDELINES APPROVED • Application Form • Guideline to Apply for Registration of Medicine • Stability Guideline • Biostudies Guideline • GMP Guideline • Clinical Trials for Human Participants • Licensing for Export/Import of Medicines • Validation (Analytical and Process)

  9. LIST OF GUIDELINES APPROVED CONT’D • Clinical Trials for HIV Vaccines • Advertising Code • Donation of Medicines • Destruction of Unwanted Medicines (For comment by member states) • Licensing of Pharmacies and Wholesalers • Marketing Surveillance • Nutritional Supplements • Recalls

  10. OUTSTANDING GUIDELINES • Complementary Medicines • African Traditional Medicines • Clinical Trials for Human Participants • Clinical Trials for HIV Vaccines • Registration of Vaccines • Terminology/Glossary

  11. SADC PROJECTS • Project on Pharmacovigilance • Project on Combating Counterfeit Medicines • Project on Pooled Procurement of Medicines

  12. PLAN OF ACTION • Two-year plan (2007 – 2009) • Implementation of regulatory guidelines • Assessment of NRAs • Strengthening capacity of NRAs • Regional training program • Strengthen QA/QC laboratories in the region • Identify and develop Centres of Excellence • Combat counterfeit medicines in the region (IMPACT) • Establish SADC Shared Network • Establish Prequalification system for Pooled Procurement of Medicines in the Region

  13. TRAINING PROGRAMME • Evaluation of application dossiers for medicines regulation and authorisation • Qualification and accreditation of QA/QC laboratories • Development and implementation of Quality Management Systems (QMS) • Market surveillance and monitoring

  14. REGULATORY CHALLENGES • Enabling legislation • Technical regulatory expertise • Availability of resources • Effective implementation of common guidelines • Availability of laboratory services • Communication and exchange of information • Availability of training facilities and resources

  15. THANK YOU • Acknowledgments: SADC Secretariat WHO • SADC websites: www.sadc.int www.ecs.sadc

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