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Tag Archives: EMA Medicinal Products

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products.

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

The reflection paper and extrapolation The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is to provide a framework and guidance for the use of extrapolation in the development of medicinal products in paediatric patients.

PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT REVISED GUIDELINE CONCERNING THE CONDITIONAL MARKETING AUTHORISATION PROCEDURE FOR MEDICINAL PRODUCTS

On 27 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a two month public consultation process on a draft revised Guideline governing the implementation of Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products falling within the scope of Regulation (EC) No 726/2004.

EMA publishes a Questions & Answers document on the practical implementation of Article 31 Pharmacovigilance Referral procedure

On 20 January 2014, the European Medicines Agency (“EMA”) published a Questions & Answers document discussing the practical implementation of the “Article 31 Pharmacovigilance Referral” procedure. The aim of the document is to address questions that marketing authorisation holders may have in relation to this procedure and the manner in which it is handled by