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
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.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017