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
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
7%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics

Click here