GMP News - Regulatory Affairs


FDA - New draft guidances for Biosimilars

FDA published the long time expected draft guidance documents on development of Biosimilars. More details can be found here.



FDA Generic Drugs Office Advances QbD, Review Processes and QM System in Anticipation of User Fees

FDA’s Office of Generic Drugs (OGD) is making significant strides forward in its efforts to implement quality by design (QbD), refine its review processes and implement a quality management system, in anticipation of the resource underpinning that user fees will provide. Read on.



Revision of the European Variations System: EU Commission publishes the Outcome of the Public Consultation

The scope of the European Variations Regulation should be extended to purely national authorisations. A concept paper on the question was published by the EU Commission in September 2011. On February, 1st, 2012, the Commission published the outcome of this consultation on its website. Read more here.



EMA counts down to Introduction of new Pharmacovigilance Legislation

The new pharmacovigilance legislation in July this year will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Read more.



New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document

The European Medicines Agency (EMA) has updated the Questions & Answers document. Current topics regarding the centralised procedure for generic/ hybrid applications have been incorporated. Read more about the questions and answers.


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