South Africa Ups Registration of New Pharmaceutical Products

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South African Health Products Regulatory Authority (SAHPRA), the organisation in charge of regulating the use of all Health Products throughout South Africa, has recently announced completion of a review of 16,000 applications for new products and variations nearly four years after it took over from the former regulator, the Medicines Control Council. (1)

SAHPRA, which was established in February 2018, said in December 2022, the conclusion of the review of applications for new pharmaceutical products registration and variations that had piled up for long, boosts South Africas drive towards ensuring timely access to safe, cost-effective medicine.

More than 95% of the cleared pending applications for new products were generic medicines.

Some of the pioneering therapies, especially those that were New Chemical Entities held up in the pipeline, were offering hope to terminally ill patients, yet access was delayed by the previous inefficient review practices, SAHPRA said.

The Agency had immediately on commencing operations in 2018 set timeframe of two years for completing the review of the pending applications with support from South Africas National Department of Health, National Treasury and private financiers with the review commencing in August 2019.

Successful conclusion of the review of the backlog of applications for new medicines, coincided with SAHPRA’s unveiling of a new approach in the implementation of the process of  health product registration renewals in South Africa. (2)

The new approach SAHPRA says is meant to ensure a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public.

South Africa had previously gazetted the Medicines and Related Substances Act that require SAHPRA to revise and renew how new medicines and variations are registered in the country.

With the implementation of the new process on registration of pharmaceutical products SAHPRA is optimistic to comply not only with the Medicines and Related Substances Act but also World Health Organization (WHO) requirements as set out in its global benchmarking tool, the IS4H-MM reference framework.

The WHO framework enables institutions and agencies such as SAHPRA to gradually embrace change in their operations as they acquire new information and knowledge capabilities.

WHOs IS4H-MM reference framework has five maturity levels with Level 5 being the highest ranking category.

It is SAHPRAs intention to attain Maturity Level 3 status and then to progress to Maturity Level 4 and be listed as a WHO listed Authority, SAHPRA said.

This step is of particular importance to the regulator and industry alike, as it may allow for Regulators from other regions to rely on SAHPRAs regulatory decision for products registered, to facilitate shorter timelines for registrations in other markets, SAHPRA says.

Since December 2022, SAHPRA has registered two Meanwhile, SAHPRA, has registered Cabotegravir (Apretude 600 mg/3ml injection), a long-acting HIV pre-exposure prophylactic barely three months after the Agency completed reviewing more than 16,000 pending applications for new medicines and variations. (3)

Cabotegravir, that is sold sold under the brand name Vocabria among other brands, is used as an antiretroviral drug (ARV)  to treat human immunodeficiency virus type-1 (HIV-1) in adult patients in combination with rilpivirine.

When such medicine is used to prevent HIV infection  that is, if it is taken before exposure to HIV  it is called pre-exposure prophylaxis, or PrEP and thus plays an important role in preventing HIV infection.

Apretude 600 mg/3ml injection is the first and only long-acting, injectable PrEP for reducing the risk of getting HIV, said SAHPRA.

Cabotegravir, which is available in the form of tablets and as an intramuscular injection, contains cabotegravir, as cabotegravir sodium, an HIV integrase strand transfer inhibitor. (4)

And in January 2023, SAHPRA registered Paxlovid, an anti-viral medicine manufactured by Pfizer to treat COVID-19.

Paxlovid, which contains Nirmatrelvir (150mg) and Ritonavir (100mg), treats mild to moderate COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19. (5)

Pfizer said at the end of January 2023, the drug had a 90% market share of the global oral antiviral market excluding China. (6)

Total global demand for the drug had reached nearly 17 million courses up from 12 million courses in 2022 with Pfizer attributing the increase to broad product availability, greater awareness and education.

However, Pfizer said it assumes no sales in China after April 1, 2023.

About the Author

Shem Oirere graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy, and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.