New EU GDP Guidelines of 07.03.2013 – Update 08.09.2013
The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project ...Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea
On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original ...EMA revised the biosimilar guideline and public consultation is now open
The European Medicines Agency (EMA) has recently published an updated biosimilars guideline for consultation that outlines the general principles that industry must take into account when developing a product ...
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