The European Medicines Agency (EMA) has published a press release and announced the next phase of its business continuity plan. According to this release the Agency will need to further scale back and suspend activities.
European Commission publishes revised Version of EU GMP Guideline Annex 2
As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".
Brexit: EMA updates information for holders of centralized marketing authorizations
The European Medicines Agency (EMA) has published updated versions of the documents provided to help marketing authorization holders prepare for Brexit.
Import vs. Manufacturing: Any Differences in the EU?
What does it mean that, in the European Union (EU), all of the requirements for and obligations of Manufacturing Authorisation holders (MIAHs) also apply to importers?
While EU and FDA GMP Guidance is very similar, there are also some areas where there are known differences. It is worthwhile being aware of these differences when dealing with companies and authorities from the "other side".
There are currently massive problems with Valsartan preparations due to contamination of the active substance. But where is it coming from? And could it have been prevented?
Both the ECA and the European QP Association are often contacted by people who would like to become a QP in an EU Member State or even outside the EU to release products for the EU market.
Post-Approval Change Management - Does ICH Q12 offer a solution?
ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".
Published in its 21st edition by now, the GMP Matrix has been a recognised standard for GMP auditors or QA units since 2005, and not only in multinational companies. The Matrix juxtaposes the US cGMP requirements as per CFR 210/211 with the EU GMP Guidelines. What has changed in recent years in particular?
Two FDA warning letters to manufacturers of creams
The US Food and Drug Administration (FDA) recently issued two warning letters to a contract manufacturers based in Australia and a Korea-based drugmaker.
The revised Annex 17 of the EU GMP Guide has been publised and will come into operation on 26 December 2018. Read more about the guideline on Real Time Release Testing and Parametric Release.
The US Food and Drug Administration (FDA) recently made available the ICH Q12 draft guidance on "Product Life Cycle Management" together with its Annex.