EN PL

News

EMA: Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

22.11.2012
This document provides guidance on the data requirements to support authorisation of combined vaccines and a claim for the use of two or more IVMPs, each with its own separate marketing ...

Polish Ministry of Health: Regulation of Polish Minister of Health on the Central Registry of Clinical Trials of veterinary medicinal products.

22.11.2012
This document is a Regulation of Polish Minister of Health concerning the Central Registry of Clinical Trials of veterinary medicinal products. ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

15.11.2012
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

EMA: Concept paper on the revision of the guideline on the development of medicinal products for the treatment of ulcerative colitis

15.11.2012
The proposed guideline will replace the guideline on the development of medicinal products for the treatment of ulcerative colitis (CHMP/EWP/18463/2006). ...

EMA: Concept paper on the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation

15.11.2012
The development of medicinal products influencing gut transit and defecation is one of the oldest principles of pharmacological treatment. Numerous products have been introduced into the market ...

EMA: Concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease

15.11.2012
The proposed guideline will replace the guideline on the development of new medicinal products for the treatment of Crohn’s disease (CPMP/EWP/2284/99 Rev. 1). ...

GMP: EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

08.11.2012
The European Commission has published a Version 2.0 of the Q&A document \"Importation of Active Substances for Medicinal Products for human use\" on 26 October. Version 1.0 was published on 10 ...

GMP: New EMA Guideline on Specifications for Impurities in Antibiotics

08.11.2012
EMA published the final \"Guideline on Setting Specifications for Related Impurities in Antibiotics\" (EMA/CHMP/QWP/199250/2009) which is coming into effect one year after on 30 June 2013. ...

GMP: EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

08.11.2012
The sensitivity of modern detection methods increased considerably during the last years. The development includes that the detection limits of adventitious agents decreased considerably too. ...

MHRA: Public consultation (MLX380): European Commission’s proposal for a Clinical Trials Regulation

08.11.2012
The European Commission proposes to simplify the rules for the conduct of clinical trials and harmonise the way trials are conducted in the European Union. The proposed Regulation will replace the ...