EC: Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use - Draft

These guidelines provide guidance on how to asses and rank the risk presented by the excipient, cover identification on appropriate GMP and assesment and present guidance on how to manage the ...

EC: Guidelines on the principles of good distribution practices for active substances for medicinal products for human use - Draft

For the purpose of these guidelines, the distribution of active substances for medicinal products for human use (hereafter \'active substances\') is the procuring, import, holding, supplying or ...

GMP: WHO GMP approaching EU-GMP

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FDA: Draft Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products

This draft guidance is intended to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use.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

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)

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

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

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

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

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 ...

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