E-DRUG: South African Paediatric Hospital Level Standard Treatment Guidelines and Essential Medicines List, 2017 (7)
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Dear E-druggers
To answer Simon's last question:
South Africa's NMRA (SAHPRA, formerly the MCC) is a member of a number of regulatory harmonisation initiatives. It is an observer at ICH, a full member of PIC/S, and contributes to the African Vaccine Regulatory Forum (AVAREF). It has also contributed to the African Medicines Regulatory Harmonisation (AMRH) initiative, and has been closely involved in the development of the Model Medicines Law for Africa and the discussions around the creation of an African Medicines Agency.
With specific reference to Zambia, South Africa contributes to the SADC Framework for Regulatory Harmonisation and has now been included in the Zazibona initiative. That started as ZAZIBONA - involving only Zambia, Zimbabwe, Botswana and Namibia - but has been expanded. Zazibona is a work-sharing initiative where each NMRA retains the responsibility for the final regulatory decision. However, no formal reciprocity or reliance agreements exist between the SADC NMRAs.
Regards
Andy
Andy Gray BPharm MSc(Pharm) FPS FFIP
Senior Lecturer
Division of Pharmacology
Discipline of Pharmaceutical Sciences
School of Health Sciences
Consultant Pharmacist (Research Associate)
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
University of KwaZulu-Natal
South Africa
Andy Gray <Graya1@ukzn.ac.za>