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EMA identifies GMP transgressors in public database

Published on 06/01/14 at 01:11pm
ema building

The European Medicines Agency has continued its march towards increased transparency by publishing - for the first time - the identities of companies that fail to meet Good Manufacturing Practice (GMP) standards.

While the FDA has made warning letters concerning GMP violations publicly available via its website for many years, until recently EMA non-compliance statements to manufacturers have been restricted to perusal by regulatory authorities.

Now, in a bid to highlight deficient manufacturers and boost quality, the EudraGMDP database includes entries for all non-compliance reports dating back to 2007.

All told there are 83 non-compliance reports available in the database so far, and the agency is no doubt hoping that publicly identifying transgressors will help encourage adherence to GMP standards.

From a regional perspective, the tally of top offenders in terms of the number of non-compliance statements is as follows:

  1. India: 35
  2. China: 22
  3. US: 4
  4. UK: 3
  5. France: 3
  6. Brazil: 2.

The database was first set up six years ago as the EudraGMP, making records of approved manufacturing and import authorisations and GMP certificates for human and veterinary medicines available to regulators.

The debut of the database also made it possible for manufacturers to submit applications in electronic form, and share information on the outcome of inspections in the EU with regulatory authorities elsewhere in the world.

Limited public access to the database was granted two years later, and the EMA has intermittently broadened its scope.

A new module to help plan GMP inspections in countries outside of the EU was added in December 2012 to help facilitate a shift towards shared inspections by the EMA and FDA and avoid redundant site visits, although this is not included in the public version.

Meanwhile, the passage of the Falsified Medicines Directive introduced a requirement for Good Distribution Practice (GDP) information to be incorporated into the database, and this took place early in 2013 with wholesale distribution authorisations, GDP certificates, statements of non-compliance with GDP and registration information for manufacturers, importers and distributors of active substances.

As a consequence the original EudraGMP database was re-christened as the EudraGMDP in April 2013. To date there are no GDP non-compliance reports listed, although it should be noted the EU's finalised GDP guidelines were not published until the previous March and only officially came into force in September.

The EMA has said it intends to make as much information in the EudraGMDP as possible available to the public, although it stresses this will never include "information of a commercially or personally confidential nature".

The ultimate decision on which information can be made public is made by the medicines regulatory authority in the member state that uploads the information to the database.

Phil Taylor

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