INSIDE PHARMA

INSIDE PHARMA

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INSIDE PHARMA
INSIDE PHARMA
What Robert F. Kennedy Jr MUST know to return FDA to the Gold Standard in Drug Regulation - Part 1

What Robert F. Kennedy Jr MUST know to return FDA to the Gold Standard in Drug Regulation - Part 1

He knows the big picture; here is the detail, part I.

Hedley Rees's avatar
Hedley Rees
Feb 10, 2025
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INSIDE PHARMA
INSIDE PHARMA
What Robert F. Kennedy Jr MUST know to return FDA to the Gold Standard in Drug Regulation - Part 1
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It begins with an internet search to ask the questions

What is the International Coalition of Medicines Regulatory Authorities (ICMRA)?

The History on the website tells us:

“In May 2012, before the 65th World Health Assembly in Geneva, more than 30 medicines regulatory authorities participated in a seminar promoted by Brazil aimed at stimulating a debate among health officials and the diplomatic community on how to improve cooperation among medicines regulatory authorities.”

What readers may not know is that the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) harmonised regulations globally from the 1990s onwards:

“The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.”

So,…

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