Middle East & Africa
A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.
The World Health Organization has also prequalified the Bavarian Nordic vaccine to enable broader and timely access.
Companies marketing pharmaceutical products in Saudi Arabia are being urged to prepare for upcoming mandatory pharmacoeconomic assessments to demonstrate the added value of their drugs over existing treatments.
The Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.
Eli Lilly will provide a know-how manufacturing guide to EVA Pharma, as it prepares to manufacture and sell baricitinib by 2026.
Manufacturer KM Biologics has confirmed to the Pink Sheet it has filed for an emergency use listing to WHO for its mpox vaccine LC16, which has shown efficacy for post-exposure prophylaxis within 14 days, although its efficacy for pre-exposure prophylaxis is still inconclusive.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
The vaccines alliance says its First Response Fund could be used to cover the cost of doses and has outlined plans for a vaccine stockpile. Some experts have criticized the slow rate of response to mpox and called for more solidarity on vaccine provision at global level.
The Africa CDC says the donation of more than 215,000 doses of mpox vaccine is a “crucial step” in tackling the latest outbreak.
An emergency use listing means the vaccines can be approved for use in lower-income countries where they are not licensed, and will allow international organizations like Gavi and UNICEF to procure them for wider distribution.
A regulatory initiative underway in Africa is testing out continental-level assessments of new drug applications that its sponsors say could provide the foundations for a “robust and well-founded” African Medicines Agency.