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GMP: WHO GMP approaching EU-GMP

14.02.2013
The current good manufacturing practices (GMP) for pharmaceutical products of the World Health Organisation (WHO) are going to be updated. WHO\'s GMP main principles are published as Annex 3 in ...

FDA: Draft Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products

14.02.2013
This draft guidance is intended to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. In this document, FDA outlines and ...

FDA: Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

07.02.2013
This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence ...

EMA: Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (draft)

07.02.2013
This guideline lays down the non-clinical and clinical requirements for low-molecular-weight-heparin (LMWH)-containing medicinal products claiming to be similar to another one already marketed. ...

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders

07.02.2013
This document is the revised version of the existing guidance note (CHMP/EWP/3020/03) on lipid-modifying agents. The guideline is intended to provide guidance for the evaluation of medicines in ...

EMA: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies

31.01.2013
From 10 January 2013, marketing authorisation holders have the obligation to comply with the format of the final study report for non-interventional post-authorisation safety studies (PASS), as ...

EMA: Guideline on good pharmacovigilance practices: Module XV – Safety communication

31.01.2013
This Module provides guidance to marketing authorisation holders, competent authorities in Member States and the European Medicines Agency on how to communicate and coordinate safety information ...

GMP: New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation

31.01.2013
The draft Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, published in January had already ...

GMP: FDA publishes Draft Guidance on Design of Medical Devices

31.01.2013
CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012. The Guidance (\"Design Considerations for Devices ...

Polish Ministry of Health:Regulation of Polish Minister of Health amending regulation concerning composition and labeling of food supplements.

31.01.2013
This Regulation of Polish Minister of Health amends regulation concerning composition and labeling of food supplements. ...

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