Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

May 252 min read

EDQM Guidance: Content of the Dossier for Sterile Substances

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a draft guideline titled "Content of the Dossier...

Aug 12, 20221 min read

Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...

Sep 5, 20211 min read

Updated Guidance for e-Submissions for CEP applications

As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...