GMP News - Regulatory Affairs

Which APIs stability information is required for a US Drug Master File within the marketing authorisation application of generic product? Read more about what DMF holders and applicants have to take into consideration in this context.

The Commission Guideline on package leaflet of centrally authorised medicinal products has been revised. Read more details here.

The Questions and Answers of the EMA on procedural questions for centralised marketing authorisations have been recently updated and completed with 2 new questions/answers. More details here.

The two guidelines on procedures and categories of variations have been recently combined in an updated document. More details about the "Variations Guideline" recently published on the Commission Website can be found here.

With a press release dated from 26 April, the European Medicines Agency (EMA) announced the CAT and Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of a combined advanced-therapy product. Read more.

EMA's "procedural advice" documents provide important recommendations and answers to questions about the centralised procedure for medicinal products. These documents have been recently brought up to the current state of the art. Read more here.

Submitting an application for a centrally authorised product is a complex procedure. Now the EMA has simplified this procedure through new regulations and presented them in an updated guide. Read more here.