Drug Regulatory Authority definition

Drug Regulatory Authority means any Governmental Entity with responsibility for granting any licenses, approvals or authorizations or granting pricing and/or reimbursement approvals necessary for the marketing and sale of pharmaceutical products in any regulatory jurisdiction.
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Drug Regulatory Authority means any governmental authority or instrumentality with responsibility for granting any licenses, approvals, authorizations (e.g., the NDA) or granting pricing and/or reimbursement approvals necessary for the marketing and sale of pharmaceutical products in any regulatory jurisdiction.
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Drug Regulatory Authority means any competent authority in any country of the Territory with authority over the Drug Product and/or a Clinical Trial including, without limitation, the FDA and the EMA;
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Examples of Drug Regulatory Authority in a sentence

  • Grant funds may only be used to procure Finished Pharmaceutical Products that have been authorized for use by the National Drug Regulatory Authority in the Host Country where the products will be used.

  • If pharmaceutical products intended for use under the Program require approval by the National Drug Regulatory Authority in the Host Country, such pharmaceutical products may be financed under this Agreement only if they have been granted such approval.

  • Its manufacturing facility is approved by the Drug Regulatory Authority of Pakistan to manufacture herbal and nutritional products and is both GMP and ISO certified.

  • Grant Funds may only be used to procure Medicine that has been authorized for use by the National Drug Regulatory Authority in the Host Country where the Medicine will be used.

  • Grant funds may only be used to procure Finished Pharmaceutical Products that have been accepted for use by the National Drug Regulatory Authority in the Host Country where the products will be used.

  • A Finished Pharmaceutical Product will be eligible for review by the Expert Review Panel if it has not yet been prequalified by the WHO Prequalification Programme or authorized for use by a Stringent Drug Regulatory Authority, but meets the following criteria: i.

  • If the clinical trial has one or more sites in India and the SAE is reported from Indian site, completed Central Drugs Standard Control Organization (CDSCO) (Drug Regulatory Authority of India) Schedule Y Appendix XI Form shall also be shared.

  • All the goods supplied shall conform to the specifications approved by the Drug Regulatory Authority of Pakistan (hereinafter referred to as the DRAP).

  • Consequently, in the event that any advantage may be received from any Drug Regulatory Authority resulting from obtaining any Marketing Authorisation hereunder and arising from the classification of the Drug Product on the WHO essential medicines list the Parties shall discuss in good faith to find a way to share the repercussions of such advantage in an equitable manner.


More Definitions of Drug Regulatory Authority

Drug Regulatory Authority means the national agency responsible for the registration of, the other regulatory activities concerning, pharmaceutical products;
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Drug Regulatory Authority means any governmental authority or instrumentality with responsibility for granting any licenses, approvals,
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Drug Regulatory Authority means each Governmental Authority that has regulatory authority over the manufacture, development, distribution, marketing, promotion or sale of the Product. Effective Date is defined in the preamble to this Agreement.
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Related to Drug Regulatory Authority

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement.

  • FDA means the United States Food and Drug Administration.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;

  • Regulatory Agencies The Office of the Comptroller of the Currency; the Board of Governors of the Federal Reserve System; the Federal Deposit Insurance Corporation; the Federal Housing Finance Agency; the Securities and Exchange Commission; and the Department of Housing and Urban Development.