This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include two new products, including Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New medicines under evaluation at the European Medicines Agency.

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.