GMP: Final ICH M7 Guideline on Genotoxic Impurities published

On on 15 July 2014, the ICH issued the guideline M7 \"Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk\" as Step 4 document. In ...

EMA: Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has revised its guide on methodological standards in ...

GMP: New GMP Non-Compliance Reports in EMA Database

The European Medicines Agency (EMA) has established a database which contains GMP and GDP compliance information. This database is called EudraGMDP. ...

RAPS: FDA Revises Policies on Obtaining Informed Consent in Clinical Trials

A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator\'s views on informed consent. ...

GMP: India blocks further Expansion of the ICH Harmonisation

India blocks the further expansion and therefore the success of the International Conference on Harmonisation (ICH). Together with some patient groups, the country wants to avoid that the World ...

EMA: Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency

Scientific and medical literature is an important source of information on suspected adverse reaction case reports (also referred to as individual case safety reports). Currently, for active ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

GMP: Waiting for ICH Q3D (Step 4): Revision and Implementation of national Regulations delayed

At the end of July 2013, the Draft Consensus Guideline \"Guideline for Elemental Impurities\" (step 2b document) was released and open for comments 6 months long. After considering all the ...

EMA: Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

The aim of this guideline is to provide guidance on the clinical development of compounds used to prevent the development and to slow the progression of chronic renal insufficiency. ...

FDA: FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

This new FDA Guidance defines the FDA\'s expectations for sponsors, CROs, investigators and other persons involved in the capture, review and retention of electronic source data generated in the ...

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