Europe Calls for Guarantee of GMP Standards - - BioPharm International

ADVERTISEMENT

Europe Calls for Guarantee of GMP Standards


RELATED ARTICLES

More in GMPs/Validation

Europe’s Falsified Medicines Directive, which came into effect in January 2013, requires that all active substances imported into the European Union (EU) have written documentation from the exporting country confirming the substance meets EU GMP standards. Confirmation is required for each manufacturing site and each substance and should provide assurance that GMPs are equivalent to EU standards; the plant is subject to enforcement and inspections, and any non-compliance findings are supplied by the exporting country promptly.

According to the European Medicines Authority (EMA), this requirement provides “a clear legal basis for the concept of international cooperation on active substances (also known as active pharmaceutical ingredients or APIs) which is based on sharing responsibilities with local regulators. These new requirements reinforce the need for pharmaceutical companies to ensure that the active substance manufacturers they are working with are registered with their respective local authorities and subject to adequate regulatory oversight, no matter where in the world they are located.”

Countries with a regulatory system equivalent to that of the EU may not need written confirmations and may request to be exempt. The requirement goes into effect July 2, 2013.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines

Click here