PHARMACEUTICALS
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 ...
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.
Subscribe now to unlock this article.
Support BusinessLIVE’s award-winning journalism for R129 per month (digital access only).
There’s never been a more important time to support independent journalism in SA. Our subscription packages now offer an ad-free experience for readers.
Cancel anytime.
Questions? Email helpdesk@businesslive.co.za or call 0860 52 52 00. Got a subscription voucher? Redeem it now.