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EMA: New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation.

09.08.2011
This guideline addresses the requirements in terms of stability testing data which drug manufacturers have to provide when applying variations to a marketing authorisation. Due to the extensive ...

FDA: PET Drugs — Current Good Manufacturing Practice (CGMP)

09.08.2011
This guidance is intended to help small businesses better understand and comply with the regulations issued by FDA concerning current good manufacturing practice (CGMP) for positron emission ...

GMP: New FDA Draft Guidance regarding Design Development of Medical Devices.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