Stringent Regulatory Authority definition

Stringent Regulatory Authority or “SRA” shall mean an Agency which is:

Stringent Regulatory Authority means a National Regulatory Authority (“NRA”) that is classified by WHO as a Stringent Regulatory Authority.

Stringent Regulatory Authority means a national regulatory authority that has been classified by WHO as a stringent regulatory authority.

Examples of Stringent Regulatory Authority in a sentence

• The Licensee shall immediately notify the Licensor of any quality audits conducted by WHO or a Stringent Regulatory Authority that results in any major observations or actions in relation to Licensed Compound and/or Licensed Product or the manufacturing sites where Licensed Compound and/or Licensed Product is being manufactured or proposed to be manufactured.

• 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.) Points 21 Narrative and applicable documents must be uploaded here or section in Technical Proposal must be referred to.

• Licensee shall file for approval of a New Formulation before either the WHO pre- qualification programme or a Stringent Regulatory Authority not later than 20 months from the Effective Date in respect of the Licensed Compound and not later than 24 months from the Effective Date in respect to at least one New Formulation, and 42 months if human trials other than bioequivalence studies are required.

• Following regulatory approval for any Product by the WHO Pre-qualification Programme and/or a Stringent Regulatory Authority, MPP will send to Pfizer within 60 days following the end of each anniversary of the Effective Date a written report setting forth a list of countries for which regulatory approvals or authorizations have been obtained during the reporting period for any Product.

• International Organization for Standardization Certificate (ISO) (as appropriate or equivalent certification from any Stringent Regulatory Authority (SRA).

More Definitions of Stringent Regulatory Authority

Stringent Regulatory Authority shall 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 means the regulatory authority of (a) a member of the Pharmaceutical Inspection Convention or an entity participating in the Pharmaceutical Inspection Co-operation Scheme; or (b) a member of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use.

Stringent Regulatory Authority means a regulatory authority which was a member or observer of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), or associated with an ICH member through a legally-binding, mutual recognition agreement, in each case as before 23 October 2015.

Stringent Regulatory Authority means regulatory authorities which are recognized and listed as a stringent by the Authority.

Stringent Regulatory Authority means a stringent regulatory authority which is a member of the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use.

Stringent Regulatory Authority or “SRA” shall mean an Agency 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) an Agency 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 means the regulatory authority of (a) a member of the Pharmaceutical Inspection Convention or an entity participating in the Pharmaceutical Inspection Co-operation Scheme; or (b) a member of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.