Medicines Regulation and Quality Assurance Systems

The focus in Medicines Regulation and Quality Assurance Systems is on establishing and strengthening national medicine regulatory authorities to develop norms and standards to ensure the quality, safety and efficacy of all pharmaceutical products and to put in place necessary infrastructures and procedures for quality assurance mechanisms. A regional framework to strengthen national medicine regulatory authorities was developed. Support is provided to medicine regulatory authorities to build their capacity, enforce national laws and regulations. The fight against circulation of substandard and counterfeit products is one of the priority areas. The Program advocates for effective enforcement of policies and regulations and promotes regional cooperation to combat the circulation and use of substandard and/or counterfeit medicines in partnership with relevant stakeholders in pharmaceuticals.

Apart from specific country support activities, the program collaborates with partners and Regional Economic Communities, among other things, on initiatives to harmonize medicine regulations. In order to enhance generation of scientific evidence on safety, efficacy and quality of traditional medicines for malaria, sickle cell diseases, diabetes and HIV/AIDS, the program has produced guidelines for clinical study on Traditional Medicines including protocols. Furthermore, capacity development and valuation of research results in pre-clinical and clinical evaluation of Traditional Medicines have been carried out. The Regional WHO collaborating centers for quality assurance of essential medicines in South Africa (http://www.puk.ac.za/cenqam/index/html) and Algeria (http://www.sante.lncpp/lnc-index.htm) provide technical support to countries as necessary.