EMA Issues Brexit Guidance
The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.
On May 31, 2017, the European Medicines Agency (EMA) and the European Commission published guidance on how pharmaceutical companies can prepare for Brexit. The guidance offers information on centralized procedures and other agency activities. The guidance is one in a series of guidance documents the agency plans to publish on the effects of the United Kingdom’s withdrawal from the European Union.
Specifically, the guidance answers some of the industry’s questions regarding the implication of Brexit on marketing authorizations, orphan drug designations, and pharmacovigilance. The document address concerns regarding the location of personnel, documents, and manufacturing facilities currently located in the UK.
Source: EMA
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
