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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here