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November 01, 2011
In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive.
July 07, 2011
The European Medicines Agency has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain.
July 02, 2011
Member states in the EU are working to implement the newly passed Falsified Medicines Directive.
June 30, 2011
The European Medicines Agency (EMA) has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation's execution.
June 03, 2011
To help you get up to speed with the ins and outs of the amended version of Annex 11, which will come into effect on 30 June 2011, PTE brings you two articles that take a close look at the amendments.
June 01, 2011
The greatest challenge faced by the EMA is the continuing expansion of the EU.
February 10, 2011
On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.
January 02, 2011
The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.
October 02, 2010
Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.
July 09, 2010
Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.