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SA regulator prioritises registration of generic medicines

Speeding up the registration of generic medicines was the top priority for the freshly minted South African Health Products Regulatory Authority (Sahpra). Business Day reports that this was according to board chair Helen Rees who 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.

The report says 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 are quoted in the report as saying that it could take up to five years to register a new chemical entity and up to three years to register a generic.

Sahpra had established a subcommittee, headed by Right to Care’s chief technical specialist for pharmaceutical policy and programmes, Shabir Banoo, to craft a more efficient way of doing business, Rees said. The committee would look at applications to register new products as well as post-registration amendments, such as a change to a supplier of active pharmaceutical ingredients. The legislation governing Sahpra enables it to share data and seek data from other regulatory authorities, which should help speed up medicine registration, she said.

"This is the way of the world. We are not the only regulatory authority that is struggling to cope, particularly with generics," Rees said. Sahpra would initially use external experts for the evaluation of applications, but over time would develop its own capacity to take over most of this work, including registration of medicines and evaluations for clinical trials.

The report says Sahpra’s board, which met for the first time on 1 February, elected former MCC director Portia Nkambule as its acting CEO. The board meeting dissolved the MCC, in line with the Sahpra Act.

Sahpra has an expanded mandate, which includes the regulation of medical devices. It is a schedule 3 public entity, which means it is no longer housed within the Department of Health and will be allowed to retain some of the revenue it collects from registration applications and offer staff more generous packages than those provided by the civil service to attract top talent. The report says the department is migrating MCC staff to Sahpra, in consultation with unions.

Aspen Pharmacare’s head of strategic trade, Stavros Nicolaou, said he was encouraged by Nkambule’s appointment, as she had a good working relationship with the industry. The Sahpra Act delegated greater authority to its CEO than had been delegated to the MCC registrar, which should streamline its processes, he said. "The early signs are promising," he said.

Rees said Sahpra’s vision included more transparency. "We need a much better communication strategy," she said, citing the UK’s Medicines and Healthcare Products Regulatory Agency as an example of an authority that did a good job on this score. "Obviously it has greater funding, but it spends a lot of money on communication, (tells people to) be careful about certain medicines and notifies them of product withdrawals."

[link url=""]Business Day report[/link]

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