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FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (Annex 4A)

10.04.2009
International Conference on Harmonisation Regions
Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (Annex 4B)

10.04.2009
International Conference on Harmonisation Regions
Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (Annex 4C)

10.04.2009
International Conference on Harmonisation Regions
Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for ...

FDA: Q10 Pharmaceutical Quality System

10.04.2009
This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, ...

EMEA: User guide on how to generate PDF versions of the Product Information

10.04.2009
Revised PDF user guide for companies describing how to correctly generate PDF versions of the Product Information ...

EMEA: Status of EMEA guidelines and European Pharmacopoeia monographs in the regulatory framework

10.04.2009
The present guideline clarifies the status of EMEA scientific guidelines and European Pharmacopoeia monographs and chapters in the context of the regulatory framework applicable ...

EMEA: Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

10.04.2009
Unwanted immunogenicity is a significant problem with therapeutic biologicals. The clinical problems associated with unwanted immunogenicity vary in nature and incidence. The importance of the ...

EMEA: Adopted guideline on similar biological medicinal products containing low-molecular-weight-heparins

10.04.2009
This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (LMWHs, low molecular mass heparins, LMMH) containing medicinal products claiming to be ...

EMEA: Community herbal monograph

10.04.2009
Community herbal monograph on Centaurii herba Centaurium erythraea Rafn., herba (centaury herb) ...

EMEA: Dossier requirements for Post-authorisation submissions in the centralised procedure

10.04.2009
Dossier requirements for (Co-) Rapporteur and CHMP members ...