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News about GMP/cGMP


FDA introduces cGMP Declarations

On September 17, the US FDA announced a new online application, cGMP declarations. FDA's CDER will send ‘cGMP declarations’ to regulatory authorities in other countries where US firms want to market drug products.


The FDA has until now not issued GMP certificates. That constitutes a problem now that there is a EU/US mutual recognition agreement on inspections and EU GMP inspectorates will no longer inspect sites in the US and therefore, also no longer issue EU GMP certificates. The newly introduced cGMP Declarations should solve this problem.

Upon receipt of a written or email request by an establishment physically located in the US that has been included as part of a marketing application submitted to a foreign regulator, FDA will issue within 30 days of receipt of the request, a written communication to an identified foreign regulator conveying the current cGMP compliance status for the establishment making the request.


The Pink Sheet News

The source link to FDA website is not working. I don't know why.
Gloria Dong 2018-10-17
Thank you very much for your helpful hint. Indeed the link we copied in our news regarding FDA’s new cGMP declarations is no longer working. On Monday it was fine. And if you do a google search the document can also be found in google’s cache (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/UCM620866.pdf). Maybe FDA took it from its website … Now we linked to the corresponding news of The Pink Sheet.
Editorial Office GMP Publishing 2018-10-17
Is it possible that the link only works if accessed from within the USA?
Siegfried Schmitt 2018-10-27
The FDA probably pulled this notification because it was ill-conceived.
Alexander F. Park 2018-10-30
Many thanks for your comments, Mr Schmitt and Mr Park. We haven't found out the actual reason for removing the announcement from FDA's website yet. We'll keep you informed.
Editorial Office GMP Publishing 2018-10-31
Literature recommendation
Data Integrity in the EU
Principles of Equipment Qualification
Classes and Grades for Air Cleanliness