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October 03, 2016
EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.
September 07, 2016
The agency published a guideline for the implementation of ICH Q3D.
September 01, 2016
The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.
July 06, 2016
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
June 22, 2016
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
June 16, 2016
The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.
May 02, 2016
Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
March 21, 2016
The agency now allows production of water for injection by non-distillation technologies.
March 15, 2016
The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.
February 18, 2016
The directorate is looking for experts to join the European Pharmacopoeia network.