Nouvelle definition de “stringent regulatory authority”

L'OMS   vient de publier, en anglais, le 51eme "Technical Report of the Expert Committee on Specifications for Pharmaceutical Preparations", qu'on peut trouver dans le site web:

Entre autres choses, ce rapport contient à la page 34, une nouvelle définition ("interim") de "Stringent Regulatory Authority (SRA)", ou autorité de réglementation rigoureuse. La définition est reportée ci-dessous, en anglais :

 "The WHO prequalification procedure and several other WHO guidance documents provide for mechanisms to rely on stringent regulatory authorities (SRAs), defining an SRA as a regulatory authority which is a member or an observer of ICH, or is associated with an ICH member through a legally-binding mutual recognition agreement. The definition originated from the Global Fund and it is reflected in the quality assurance policies of most major international organizations involved in procuring medicines. ICH has undergone structural changes and has expanded its reach to include organizations and associations at the global level. In view of these developments the WHO Secretariat proposed an interim definition of an SRA. The interim definition of an SRA will include the same elements as the current definition, each qualified by the wording "as before 23 October 2015", as follows:

A regulatory authority which is:

a. a member of the ICH, being the European Commission, the US FDA and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or

b. an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or

c. a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).

The Expert Committee adopted the interim definition and noted the work being done towards developing a new approach to the assessment of national regulatory authorities, based on the various existing systems currently in place such as that used by the Pan American Health Organization and that applied by WHO with respect to vaccines. The Committee requested that an update on this work be provided at its fifty-second meeting. "