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MHRA: Public consultation on the revision of European legislation on medical devices

22.11.2012
The MHRA is seeking the views of healthcare professionals, patients, industry, academics, and the interested public on the draft new European legislation on medical devices. In September the ...

FDA: FDA Safety Communication: Updated information on the risks of thrombosis and hemolysis potentially related to administration of intravenous, subcutaneous and intramuscular human immune globulin products

22.11.2012
This update is in follow-up to the FDA Interim Statement Regarding Immune Globulin Intravenous (IGIV), dated August 22, 2002, regarding thrombotic events following IGIV infusion. This Safety ...

EMA: Guideline on the demonstration of palatability of veterinary medicinal products - Draft

22.11.2012
The objective of this guideline is to specify requirements for the design, conduct, and evaluation of palatability studies for all oral dosage forms of pharmaceutical veterinary medicinal products ...

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 ...

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