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Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

27.04.2010
This guideline is intended to provide advice on the preparation of annual reports on the state of development of an orphan medicinal products. ...

Annual Report of the Pharmacovigilance Inspectors Working Group for 2009

27.04.2010
This document is the second Annual Report of the PhV IWG. The PhV IWG focuses on harmonization and co-ordination of PhV related activities at Community level. ...

Public consultation on Annex 2 of the GMP laying down the guidelines for the manufacture of biological medicinal substances and products for human use

27.04.2010
Annex 2 is proposed to be revised as a consequence of the restructuring of the GMP guide, the increased breadth of biological products to include several new product types such as transgenic ...

FDA: Guidance for Industry – Q4B Evaluation and Recommendation of Pharmacopoeial Text for Use in the ICH Regions

15.04.2010
This Annex is the result of the Q4B process for Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group. ...

EU Ministry of Health: Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies

15.04.2010
Within the European Union veterinary medicinal products are regulated by legislation throughout their entire lifetime on the basis of scientific expertise. In order to ensure the quality, safety ...

FDA: Guidance for industry – dosage and administration section of labeling for human prescription drug and biological products

08.04.2010
The goal of this guidance is to help ensure that the dosage and administration section contains all the information needed for safe and effective dosing and administration of a drug and the ...

EMA: European Medicines Agency standard operating procedure (SOPs) on: Type IA variations to centralised marketing authorisations (medcines for human use)

08.04.2010
The purpose of this SOP is to describe the procedure for handling of Type IA variations to centrally authorized medicinal product for human use. It applies to the Quality of Medicines and Safety ...