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September 30, 2013
EMA revises HIV treatment guideline.
September 17, 2013
EMA releases details of restructuring.
September 02, 2013
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
August 20, 2013
Agencies collaborate to ensure consistent product quality.
August 06, 2013
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
July 02, 2013
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
June 11, 2013
EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
May 08, 2013
EMA streamlines orphan drug application procedure.
March 02, 2013
FDA's requirements for API manufacturers in regards to ICH Q7.