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GMP: New FDA Draft Guidance regarding Design Development of Medical Devices.

09.08.2011
The goal of this guidance is to assist the medical devices industry in performing appropriate human factors testing on medical devices in order to reduce use error and injuries. The FDA hopes that ...

EMA: Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

02.08.2011
The Guideline on Similar Medicinal Products containing Low-Molecular-Weight Heparins (LMWH) lays down the non-clinical and clinical requirements for the development of LMWH claimed to be similar ...

EMA: Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin

02.08.2011
The current Guidance on Similar Medicinal Products containing Recombinant Human Insulin provides recommendations for the development of recombinant soluble (short-acting) human insulin claimed to ...

EMA: Guideline on bioanalytical method validation

02.08.2011
This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative ...

HMA: CMDh Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

02.08.2011
These Best Practice Guides are intended to facilitate the practical application of the guidance for the handling of Mutual Recognition variations outlined in Notice to Applicants, Volume IIA, ...

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. ...