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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 ...

EMA: Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use

09.05.2013
The European Commission has decided to revise the \'Guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00 Rev.1)\'. A concept paper on the need ...

EMA: Draft guideline on the use of phthalates as excipients in human medicinal products

09.05.2013
Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available ...

EMA: Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure

09.05.2013
A Community marketing authorisation is valid throughout the European Union and the invented name of the medicinal product is an integral part of the authorisation.The centralised procedure ...

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