Drug Regulatory Authority definition

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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Drug Regulatory Authority means the national agency responsible for the registration of, the other regulatory activities concerning, pharmaceutical products;
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Examples of Drug Regulatory Authority in a sentence

  • Stringent Drug Regulatory Authority (SRA) means a regulatory authority participating in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (www.ich.org).

  • Good Manufacturing Practices (GMP) Certificate.Valid Good Manufacturing Practices (GMP) Certificate issued by the Drug Regulatory Authority of Pakistan (DRAP).

  • Non Cancellation / Suspension of Drug Registration of quoted product of the bidder by Drug Regulatory Authority of Pakistan within last two years.ii.

  • Non Cancellation / Non Suspension of Registration of quoted product of the bidder by Drug Regulatory Authority of Pakistan within last two years.

  • NON Cancellation / Suspension of Drug Registration of quoted product of the bidder by Drug Regulatory Authority of Pakistan within last two years.ii.

  • The bidder shall also have to submit a copy of valid registration certificate from Ministry of Health, Islamabad / Drug Regulatory Authority Pakistan.

  • 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.

  • The bidder shall also have to submit a copy of registration certificate from Ministry of Health, Islamabad/ Drug Regulatory Authority Pakistan.

  • Your child’s records may be reviewed by the [insert name of national Drug Regulatory Authority], [insert name of site IRB/EC], [insert name of other local regulatory authorities], name the National Institutes of Health (NIH) and its study monitors, the United States Office for Human Rights and Research Protections (OHRP), other U.S., local, and international regulatory entities, the United States Food and Drug Administration (FDA), study staff, and study monitors supporting this study.

  • 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.


More Definitions of Drug Regulatory Authority

Drug Regulatory Authority means any Governmental Body or instrumentality with responsibility for granting any licenses, approvals, authorizations or granting pricing and/or reimbursement approvals necessary for the marketing and sale of pharmaceutical products in any regulatory jurisdiction including, without limitation, the FDA (as defined below).
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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, with respect to a particular country, extra-national territory, province, state, or other regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required for such country, extra-national territory, province, state, or other or regulatory jurisdiction, pricing or reimbursement approval of a Product in such country or regulatory jurisdiction, including the FDA, the EMA, the European Commission and MHLW, and in each case including any successor thereto.

  • national regulatory authority means a national regulatory authority designated in accordance with Article 39(1) of Directive 2009/73/EC;

  • Regulatory Authorities means the Commissions and the Exchange;

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • 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.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, listings, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies necessary for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product in any country or jurisdiction, including any Investigational Application.

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in the state in which such Insurance Subsidiary is domiciled.

  • MFDA means the Mutual Fund Dealers Association of Canada;

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

  • statutory authority This agreement implements Iowa Code § 280.25 and is consistent with 34 C.F.R. 99.38 (2012).

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Competent Supervisory Authority means a supervisory authority which has jurisdiction in relation to the activities of a controller or processor under European data protection law in a particular Member State;

  • Canadian Securities Regulatory Authorities means, collectively, the securities regulatory authority in each of the provinces and territories of Canada;

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory entity means any board, commission, agency,

  • DP Regulator means any governmental or regulatory body or authority with responsibility for monitoring or enforcing compliance with the Data Protection Laws;

  • 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.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).