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RAPS: Biosimilars in the EU: New IMS Report Shows Savings Through Competition

11.05.2017
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The ...

EMA: New guide on biosimilar medicines for healthcare professionals

11.05.2017
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that ...

EMA: Release of documents on two medicines temporarily halted

23.03.2017
Release of documents on two medicines temporarily halted.
EMA’s appeals against interim measures are dismissed by Court of Justice.
The Vice-President of the Court of Justice ...

FDA: Considerations in Demonstrating Interchangeability With a Reference Product

10.02.2017
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal products for human use

10.02.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal ...

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

07.12.2016
Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum ...

1000th Procedure HMA Voluntary Harmonisation Procedure (VHP) for clinical trials

07.12.2016
The European Voluntary Harmonisation Procedure for clinical trials (VHP) was first established in March 2009. Now, the 1000th application for the evaluation of a clinical trial has been received ...

Procedural advice on the certification of quality and non-clinical data for small and medium sized enterprises developing advanced therapy medicinal products

07.12.2016
Article 18 of Regulation (EC) No 1394/20071 provides that Small and Medium-sized Enterprises (SMEs) developing an Advanced Therapy Medicinal Product (ATMP) may submit to the European Medicines ...

EMA: Opening up clinical data on new medicines

25.10.2016
EMA provides public access to clinical reports As of today, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised in the European ...

EMA: First comprehensive overview of global initiatives on medicine regulation published

20.10.2016
The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the ...