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ICH Expansion Prompts WHO To Review Definition Of 'Stringent Regulatory Authorities'

 
• By Vibha Sharma

European research-based pharmaceutical industry association, EFPIA, says it "makes sense" for the World Health Organization to review the concept of "stringent regulatory authorities," which is linked to a country's membership of the International Council for Harmonisation.

Change
The WHO wants to change its definition of stringent regulatory authorities • Source: Shutterstock

The World Health Organization is inviting feedback on its proposal to change its definition of "stringent regulatory authorities," which at present is directly linked to a regulatory authority's membership of the International Council for Harmonisation.

The proposal has been prompted by recent structural changes at the ICH, which has resulted in the organization expanding. For example, there are now new ICH members – such as Brazil's ANVISA, South Korea's MFDS and China's CFDA – that have not yet had time to implement all the ICH guidelines

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