Zazibona Essay

1. SADC collaboration in medicines registration (Zazibona)

A presentation on the SADC collaboration in medicines registration (Zazibona) was made. It was highlighted that the collaboration is intended to remove duplication, and efficiently use the available resources to ensure availability of quality medicines while reducing the time taken to regulatory decisions Zazibona is recognised as a technical working group under the SADC Medicines Regulators Forum and the mechanism for implementing assessment and inspection activities to facilitate medicines registration by the Member States. Four Member States Botswana, Namibia, Zambia and Zimbabwe have been participating since its inception in mid 2013. The assessors meet four times a year, while the Heads of Agencies meet twice a year and two to four GMP inspections are performed per year. On average

The presentation covered the principal concepts of product information, tripartite approach of summary of product characteristics (SmPC) intended for health professionals, patient information leaflet (PIL) intended for the patient or user and product labelling. Further, the contents and structure of the SmPC; structure, content, format and style of PIL as well as minimum requirements for product labelling were discussed. The product information is important for the safe use of the product by health professionals as well as the patients or user and for detecting counterfeit products. Product information is part of the regulatory approval decision for a product, legally binding and is the responsibility of the marketing authorisation holder. Any product information changes require regulatory approval. In principle, product information for the innovator product is based on the scientific efficacy and safety data while that for a generic product is based on the copy of the reference/innovator