# \[e-drug\] Harmonising registration systems **URL:** https://talk.edrugplus.org/t/e-drug-harmonising-registration-systems/32993 **Category:** e-drug **Created:** [December 20, 2009, 1:03am UTC](https://talk.edrugplus.org/t/e-drug-harmonising-registration-systems/32993 "2009-12-20T01:03:19Z") **Posts on this page:** 1 **Page:** 1
### Author: ![jbrusso](https://avatars.discourse-cdn.com/v4/letter/j/7c8e57/32.png) [@jbrusso](https://talk.edrugplus.org/u/jbrusso) #### Post date: [December 20, 2009, 1:03am UTC](https://talk.edrugplus.org/t/e-drug-harmonising-registration-systems/32993/1 "2009-12-20T01:03:19Z")
E-DRUG: Harmonising registration systems ---------------------------------- Philippa Saunders makes a compelling argument for harmonization of registration schemes among nations while avoiding compulsory adherence -- allowing individual regulatory authorities to make their own best judgments on behalf of the populations they serve. Some of us are old enough to remember the regulatory climate in the first years of thalidomide, 1957-61. The drug had earned wide use in first-trimester nausea after registration in Europe and the British Commonwealth -- while FDA's Frances Kelsey held off, for several reasons, one being the drug's effects on the developing nervous system. Dr. Kelsey's reasoned prudence of course saved untold thousands of lives and immeasurable heartache. Certainly a strong argument exists for increased regulatory harmonization -- for getting along by going along -- but the need to retain, as a sovereign right, what might be called the Frances Kelsey exception ought never be forgotten. Cordially, James B. Russo Founding Executive Director Partnership for Quality Medical Donations 146 Koenig Rd. Bernville, PA 19506 USA 610 488 9060 jbrusso@aol.com