Collab to address medicines’ registration backlog

The logo of the National Association of Pharmaceutical ManufacturersThe National Association of Pharmaceutical Manufacturers (NAPM) has welcomed a recent statement issued by the Medicines Control Council’s (MCC) Secretariat. The statement announces the MCC’s plans to embark on project, jointly developed with the pharmaceutical industry, to dramatically reduce the backlog of registration applications for medicines.

For many years the pharmaceutical industry, and in particular generic medicine manufacturers, has complained about the time it takes for the MCC to approve a generic medicine. The delay of around five years is detrimental to both the industry and patients in South Africa. This is because it denies access to more affordable medicines and dissuades companies from further investment in the country.

Two-stage strategy

The statement from the MCC indicates that there will be two phases to the plan. The first is estimated to be concluded by this December. The industry reckons that this will release some 100 new generic medicines on the market, increasing the patient’s choice of access to treatment.

CEO of the NAPM, Vivian Frittelli, says that this action by the MCC bodes well for the future, especially as the MCC transforms into the South African Health Products Regulatory Authority. This transformation is due to culminate in April 2017.


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