Stringent Regulatory Authority (SRA definition
Stringent Regulatory Authority (SRA means a regulatory authority which is:
(a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration 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).
Stringent Regulatory Authority (SRA means regulatory authorities which are recognized and listed as stringent by EFDA.
Stringent Regulatory Authority (SRA means a regulatory authority which is a member, observer or associate of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time.
Examples of Stringent Regulatory Authority (SRA in a sentence
Please list the manufacturer certificates required to perform the assessment and the acceptance criteria applied (e.g. for medicines: manufacturer must provide GMP certificate from a Stringent Regulatory Authority (SRA) as per WHO definition etc.) Narrative and applicable documents must be uploaded here or section in Technical Proposal must be referred to.
International Organization for Standardization Certificate (ISO) (as appropriate or equivalent certification from any Stringent Regulatory Authority (SRA).