Head Office 4th Floor 135 West Street Sandown 2196 PO Box 55132 Northlands 2116 South Africa Tel +27 11 883 0205/6/7 Fax +27 11 784 2818 Email us here   Regulatory Process for Trials in South Africa Why Clinical Trials in South Africa? Thumbnail Sketch of South Africa Regulatory Process for Trials in South Africa Health Authority Medicines Control Council (MCC). Secretariat (MRA) based in Pretoria Clinical trials reviewed by external reviewers and MCC’s Clinical Trials Committee Bioavailability/bioequivalence studies processed faster by in-house review All reviewer recommendations must be ratified by Council (8 annual meetings) All trials with unregistered products and new ex-label indications require MCC approval Review Cycle: 8-12 weeks (7-14 days for bioequivalence studies) Application fees apply for full Clinical Trial Applications and Amendments Three-part CTF1 Application Form imposes detailed country-specific requirements influenced by current healthcare, ethical and political priorities over and above An application requires careful compilation of drug-specific and protocol-specific summaries, motivations and justifications, supported by numerous appendices (key study documents, CVs, declarations and certificates) CTA compilation requires scientific expertise and knowledge of local environment. Ideally, allow at least 3 weeks’ preparation time Applications that cut-and-paste wholesale from FDA/EC dossiers do not succeed Department of Health has published national GCP Guidelines, last updated in 2006 compatible with ICH GCP and emphasizing country-specific requirements for vulnerable populations Unlike a US IND, at least 80% of planned sites must be submitted in original CTA Review cycle ends with approval at Council meeting (6 meetings annually) National Research Register All clinical trials must be listed on SA National Research Register prior to Ethics Committee application Register is maintained by the National Health Research Ethics Council, which governs, inspects and accredits individual committees Ethics Review Academic institutions must apply their own committees Two IRB-constituted private Ethics Committees (EC) for non-academic affiliated sites Application fees are charged for review of full protocols and amendments Ethics and MCC submissions usually run in parallel Ethics Committee review normally takes 4-6 weeks Realistic Advice to Sponsors As there are only 6 MCC meetings annually, plan submissions well ahead We recommend minimum 3 weeks preparation time for CTF1 compilation (more for multi-site trials requiring site evaluations and document collection The MCC rejects sub-standard and incomplete applications Applicant recieves Review Queries approximately mid-cycle. Multiple queries can delay approval (and thus clinical start) by an entire review cycle Compilation by a CRO with local regulatory expertise and an understanding of the prevailing healthcare priorities, working closely with the sponsor’s experts, maximises the likelihood of a successful delay-free review HOME LEGAL NOTICES CONTACT US SITE MAP