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The European Medicines Agency (EMA) and the French Agence nationale de sécurité du médicament et des produits des santé (ANSM) published a Non-Compliance Report after a Pre-Approval Inspection for three biosimilar products of Biocon Limited in Bangalore, India.
Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.
The European Medicines Agency (EMA) expects some uncertainty and higher workload because of the Brexit. Now, the EMA has defined three categories to prioritise activities in a business continuity plan.
Just like the FDA's Warning Letters which have been publicly available for many years, the EU non-compliance reports are also accessible now for some time past. Therefore, it's interesting to take a look at those deficiency reports which have been addressed to the same manufacturer. Read here which GMP violations by manufactureres of APIs were found by FDA as well as EU GMP inspectors.
The EMA announced on July 14, 2017, that it has revised three post-authorization activity guidance documents, including type II variations, post-authorization safety studies and changes related to quality aspects. Read more EMA´s updated post-authorizaiton guidelines.
The India-based pharmaceutical manufacturer Mylan Laboratories received a Warning Letter by the FDA in April 2017. The FDA inspector found that over 70% of initial OOS results were invalidated without sufficient investigation to determine the root cause of those OOS results and that there was no appropriate trending. Get more information about the Mylan Laboratories FDA Warning Letter.