On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EUROPEAN COMMISSION PUBLISHES REPORT ON EXTERNAL REFERENCE PRICING FOR MEDICINAL PRODUCTS
The report identifies the main parameters which impact the pricing and reimbursement decisions for medicinal products within external reference pricing systems. These parameters include the effects of pricing and reimbursement decisions for medicinal products taken in one EU Member State on pricing and reimbursement decisions in other EU Member States.
Based on a simulation model, the assessment identified these main parameters in all 28 EU Member States. The report also briefly examines the external reference pricing processes in non-EU countries such as Australia, Canada, Japan and Turkey.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017