New Filings At The EMA
Executive Summary
New medicines under evaluation at the European Medicines Agency.
This is a regularly updated list of products that have been filed with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) under the EU's centralized authorization procedure.
The information is based on the EMA's monthly updated list of medicines under review at the agency, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet. The latest list from the EMA was compiled on 6 January. (Also see "ViiV Wins Fast-Track Review At EMA For HIV Therapy" - Pink Sheet, 20 Jan, 2020.)
The EMA does not identify in its own list the sponsors of marketing authorization applications that are under review. It gives only the international non-proprietary name (INN) and therapeutic area. For generic and biosimilar medicines, it provides the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. The CHMP monthly meeting agendas sometimes identify the name of sponsors of orphan drugs only.
The EMA only lists information on medicines whose applications have been validated at the time the agency's list in question or CHMP agenda is compiled.
Information on CHMP opinions and on EU approvals can be found elsewhere in the EU Performance Tracker section of the Pink Sheet website.
Information on the different types of applications or approval pathways involved – for example, accelerated assessment, informed consent application, conditional approval – is provided in footnotes below the table.
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