EMA Adds Statements of GMP Non-Compliance to EudraGMDP - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Adds Statements of GMP Non-Compliance to EudraGMDP


The European Medicines Agency (EMA) has launched a new version of the EudraGMDP database, which includes, among other changes, the publication of statements of non-compliance with good manufacturing practice (GMP). These non-compliance documents, as well as positive GMP certificates, are now publicly accessible, EMA reports.

Statements of non-compliance contain information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health. These statements aim to establish a coordinated and harmonized response by the network of European Union (EU) medicines regulators.

EudraGMDP is a database operated by the EMA that supports the exchange of information on GMP compliance and non-compliance, as well as on manufacturing and importation authorizations, among European regulatory authorities and regulators outside the EU. 

As of April 2013 the database also includes information on good distribution practice (GDP) compliance; registrations of active substance manufacturers, importers and distributors; and wholesale distribution authorizations. 

Most information contained in EudraGMDP is publicly available. Confidential information is not made public. The decision on which information to make public is taken by the medicines regulatory authority in the EU Member State that adds the information to the database.

Source: European Medicines Agency

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns

Click here