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

17.07.2014
A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator\'s views on informed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

17.07.2014
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

10.07.2014
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

10.07.2014
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

10.07.2014
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

10.07.2014
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

10.07.2014
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 ...

EMA: Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products

10.07.2014
This document applies to the follow-up of pharmacovigilance inspections of MAHs with centrally authorised products (CAPs) and nationally authorised products (NAPs) including those authorised via ...

RAPS: FDA Outlines Regulatory Approach for Nanotechnology

10.07.2014
The US Food and Drug Administration (FDA) has finalized a 2011 guidance document outlining its regulatory approach for nanotechnology products, including medical products. ...

GMP: APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants

18.06.2014
An APIC multinational working group has compiled a new guidance on cleaning validation with the title \"APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients ...