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 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).

Examples of Stringent Regulatory Authority in a sentence

• For the purposes of this Section 6.2(b) a Stringent Regulatory Authority is defined as Regulatory Authorities which are members, observers or associates of the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time.

• Notwithstanding the foregoing, the Licensee may submit requests to the Licensor for transmittal to Novartis seeking written approval from Novartis to waive such restrictions on capsule colors only in cases where such request may expedite Products to market and Stringent Regulatory Authority approval has been obtained.

• For the purposes of this Section 6.2(b) a Stringent Regulatory Authority is defined as regulatory authorities which are members, observers or associates of the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time.

• 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.

• 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.

More Definitions of Stringent Regulatory Authority

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

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

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 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 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 means a regulatory Authority that has international recognition and stringent regulatory requirement, practices and trend past history for registration of pharmaceuticals and site GMP Inspection;