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EMA: Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

06.06.2013
Since the publication of the EMA Guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease (CPMP/EWP/563/98) in 2000, there has been an intense ...

EMA: Guideline on the use of bovine serum in the manufacture of human biological medicinal products

06.06.2013
This guideline replaces Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02). ...

EC: Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to

06.06.2013
These guidelines apply to the variations of marketing authorisations for medicinal products for human use and veterinary medicinal produ cts granted in accordance with Regulation 726/2004, ...

EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogen

23.05.2013
The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential ...

GMP: WHO publishes Draft on Revised Process Validation Guideline: Validation Life-Cycle Required

23.05.2013
The WHO has published a proposal for the revision of its supplementary guideline on GMP validation (Annex 7: non-sterile process validation). ...

GMP: Handling of APIs and Excipients - New Guidelines in Chapter 5 of EU GMP Guide

23.05.2013
The European Commission published the re-revised version of draft chapter 5 - Production - of the EU GMP Guide for comment. The chapter entitled \"Production\" deals with many aspects which are ...

EMA: Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products

16.05.2013
This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing ...

EMA: Procedure for orphan-medicinal-product designation: Guidance for sponsors.

16.05.2013
This Regulation lays down a Community procedure for the designation of medicinal products as orphan medicinal products and provides incentives for the development and placing on the market of ...

FDA: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data

16.05.2013
This guidance describes best practices pertaining to conducting and reporting on pharmacoepidemiologic safety studies that use electronic healthcare data, which include administrative claims data ...

EMA: Draft guideline on similar biological medicinal products

09.05.2013
This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive ...

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