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.
The European Medicines Agency has awarded a grant to a pilot program that is trialing procedures for the joint assessment of drug approval applications at continental level in Africa.
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Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.
Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.
Japan ships the first batch of 50,000 mpox vaccine doses to DRC after training local healthcare providers dealing with the persistent outbreak.
Egypt is the first African country to win a WHO maturity level 3 benchmarking rating for medicines and vaccines that are locally produced and imported.
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.
