GMP News - Regulatory Affairs


Revised Guideline Draft on Biosimilar Medicinal Products published

At the end of May, the EMA published a draft of the biosimilar guideline from 2006 for comment. This guideline describes the requirements on quality evidence for biosimilar medicinal products. Read more here about the updated instructions.



EMA - Regulatory procedural Advice on similar biological medicines

In April, the European Medicines Agency published a new document on regulatory procedural advice on similar biological medicines. This guidance should provide help for the applicants to submit applications, which are in conformity with the legal and regulatory requirements. More details can be found here.



The new EMA's eSubmission Gateway for Centralised Authorisations is released!

EMA's eSubmission Gateway was released on 23 April 2012. This portal for the internet-based transmission of documents related to the authorisation for centralised procedures is now available for all applicants. Read more here.



New EMA Questions and Answers Document on Post Approval Change Management Protocols

The post approval change management protocol is an important document for every marketing authorisation holder which must be approved by the regulatory authority. The EMA has recently published a Questions and Answers document to clarify some principles of this protocol. Read more here.



New Requirements for the Submission of Information on Medicinal Products - EMA publishes New Guidance for MAHs and a revised "Legal Notice"

As from 2 July 2012 the provisions of Regulation (EU) No. 1235/2010 will come into effect. Marketing authorisation holders will face a range of new requirements. In addition to other obligations they will be obliged to provide comprehensive data on medicinal products and their marketing authorisation status to the EMA. More details here.



FDA's new web-based Training explains FDA Drug Regulatory Work

Many people from pharmaceutical industry all over the world want to learn about the regulations and processes of FDA's Center for Drug Evaluation and Research (CDER). FDA now introduces a new free e-learning tool. Read more.



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FDA published the long time expected draft guidance documents on development of Biosimilars.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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