Gilead chained FDA, EMA and WHO reviews so Zambia could approve lenacapavir in 12 days

An Asterisk article by Enlli McAleese explains how Zambia's medicines regulator, ZAMRA, approved Gilead's twice-yearly HIV prevention injection lenacapavir in 12 working days. ZAMRA has roughly 150 staff and has not reached level 3 of 4 on the WHO maturity framework; over 90 percent of what it reviews is generics. The article says low- and middle-income countries typically see a four-to-seven-year lag after approval in a wealthy country.

Gilead's answer was regulatory reliance: a relay in which each step builds on the previous one. It filed with the FDA, which gave priority review, then went to the EMA in February 2025 under EU-M4all, a procedure for medicines meant for use outside the EU. Experts from WHO, Zambia, Uganda, Kenya, Nigeria, Zimbabwe, South Africa, Thailand and Vietnam joined that assessment under confidentiality agreements and saw the unredacted trial data. The EMA reviewed in 120 days instead of 210 and gave a positive opinion in July 2025.

Gilead then applied to WHO prequalification in August 2025. Under guidance expanded in March 2025, an abridged pathway could now include products approved only for use outside the EU; lenacapavir was the first to use it. The review checks that the product matches what the EMA assessed and, in this case, asked for stability data for hot, humid storage. WHO prequalified it on October 6, 2025, after 36 days.

Prequalification passed the unredacted EMA assessment and inspection reports down to national regulators. According to the article, ZAMRA did not re-evaluate the data. It verified Gilead's declaration that the product was the same as the prequalified one, checked samples and a certificate of analysis, and handled local labeling and postmarket requirements. It approved on November 4, 2025.

Most of a drug assessment is universal and was already done several times by regulators doing the same job.

EU-M4all put African regulators inside the EMA review before they had to decide anything.

WHO prequalification is also a gateway to procurement by buyers such as UNICEF and the Global Fund.

Each regulator still takes the final decision and responsibility for its own country.

Where a slow gate duplicates work done elsewhere, sequence the earlier gates so their output is shareable and the last gate only checks what is local.

The article's text available to this writer stops at ZAMRA's approval on November 4, 2025 after 12 working days. The WHO's 36-day prequalification was about a fifth of the FDA's priority review and a quarter of the EMA's.