First comprehensive overview of global initiatives on medicine regulation published

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13/10/2016

First comprehensive overview of global initiatives on medicine regulation published

Mapping aims to improve international collaboration

The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The report lists all international projects and provides international regulatory agencies with comprehensive details on the number and scope of global initiatives that can support decision-making regarding future engagement, prioritisation and coordination.

The aim of the mapping exercise was to raise awareness of ongoing international regulatory activities, help establish a basis for a more strategic coordination to avoid duplication of efforts, and identify possible gaps.

The report includes not only broad ranging activities such as the harmonisation work of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), but also identifies areas of particular strategic interests for ICMRA. These include: generic medicines, good manufacturing practice inspections, exchange of confidential information, supply-chain integrity, crisis management, pharmacovigilance and information technology systems. Specific mappings in these areas will be published by EMA in early November 2016.

The new report was presented at a summit of heads of medicines regulators and the annual ICMRA meeting which is currently taking place in Interlaken, Switzerland, ending today. For further information , see the media release on the summit

The next summit and face-to face meeting of the coalition will take place in Kyoto, Japan, in October 2017.

ICMRA was set up in 2013 by the heads of a number of regulatory authorities from across the globe. Its purpose is to address current and emerging challenges in global human medicine regulation and to provide clear direction for common activities and areas of work. One of the aims of the coalition is to identify ways to better use existing initiatives and resources to tackle shared problems such as the growing complexity of globalised supply chains.

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Mapping of international initiatives - report

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