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EMA: Guide on the Interpretation of Spontaneous Case Reports of Suspected Adverse Reactions to Medicines

02.08.2011
This document provides guidance on how to interpret information on spontaneously reported cases of suspected adverse reactions to medicines. It also gives an overview of current pharmacovigilance ...

EMA: Guideline on plasma-derived medicinal products

02.08.2011
This guideline provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention is given to the virus ...

EMA: Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development.

02.08.2011
The increasing knowledge of variation within the human genome is being used for the development of personalised and stratified medicine, with the aims of decreasing the number of adverse drug ...

EMA: Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis

26.07.2011
New treatment options e.g. immunosuppressants prompt to reconsideration of treatment targets, target population, trial design, choice of endpoints, among others. In the dawn of treatments intended ...

Polish Ministry of Health: Regulation concerning on the amount and method of charging for the authorization to the manufacture of advanced therapy medicinal products.

26.07.2011
Regulation of the Polish Ministry of Health of 29.06.2011 concerning on the amount and method of charging for the authorization to the manufacture of advanced therapy medicinal products. ...

Polish Ministry of Health: Regulation concerning on specimen form of application for permission to the manufacture of advanced therapy medicinal products

26.07.2011
Regulation of the Polish Ministry of Health of 29.07.2011 concerning on specimen form of application for permission to the manufacture of advanced therapy medicinal products. ...

GMP: New: ICH Guideline for ICH Q8, Q9 and Q10 implementation

26.07.2011
On 16 June 2011 the International Conference on Harmonisation (ICH) Quality Implementation Working Group published a new document entitled: \"POINTS TO CONSIDER ICH-Endorsed Guide for ICH ...

Polish Registration Office: Communication of the President of Registration Office on the implementation of the principles of post authorization changes.

26.07.2011
In connection with the Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and ...

EMA: Guideline on stability testing for applications for variations to a marketing authorization

26.07.2011
The following guideline provides guidance on the stability data which have to be generated in order to support a variation to a Marketing Authorisation. The guideline provides general guidance on ...

EMA: Concept paper on the need for revision of the Guideline on non-clinical local tolerance testing of medicinal products (CPMP/SWP/2145/00).

26.07.2011
The existing guideline on local tolerance is dated 1 March 2001 (1). Over the past years, newer routes of administration, e.g. transdermal systems, are being used more frequently and a shift has ...