Regulator prioritises faster registration of generic medicines
The pharmaceutical industry has high expectations of Sahpra after extensive delays
Speeding up the registration of generic medicines was the top priority for the freshly minted South African Health Products Regulatory Authority (Sahpra), board chairwoman Helen Rees said on Monday. The authority, which replaced the Medicines Control Council (MCC) at the beginning of February, is the consumer watchdog for the pharmaceutical industry and is responsible for determining which medicines may be marketed in the country. The pharmaceutical industry has high expectations of Sahpra, as it hopes the extensive delays in getting products approved by the MCC will soon end. Industry sources have told Business Day that it could take up to five years to register a new chemical entity and up to three years to register a generic. Rees said Sahpra had to clear a backlog of thousands of products. "We have to address this as a matter of urgency, with a new approach to doing safe reviews. The way we were doing things before is no longer fit for purpose," she said. Sahpra had established ...