On its website, the European Medicines Agency (EMA) offers a Q&A page which contains a collection of questions and answers on all regulatory activities linked to the issue of drug marketing authorisations. This Q&A page is usually updated on a short notice. Based on the regularity of new developments, a compilation of these questions and answers is published as a guideline entitled "Post-Authorisation Procedural Advice Human Medicinal Products". The document - available as a PDF file - contains all new regulations issued since the publication of the last version.
On 25 March 2011, the EMA published the 18th revision of the Post-Authorisation Guideline. Additionally, the respective changes on the Q&A page were updated. Following topics are addressed by the update:
The Post-Authorisation Guideline has a very extensive scope and covers almost all questions around the regulatory processes of post-authorisations. This guideline can be used as a reference document as well as the Q&Q page which is organised by topic.
Find more information in the Post-Authorisation Guidelineand on the Q&A page.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Note: The ECA Education Course "Handling Changes and Variations" in Prague, Czech Republic, from 10-11 May 2011 will focus on the changes in marketing authorisation dossiers.