Health Regulatory Authority definition

Health Regulatory Authority means the FDA.
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Health Regulatory Authority means the statutory or Governmental Authorities authorized under applicable laws to protect and promote public and animal health through regulation and supervision of therapeutic drug candidates intended for use in humans, including, without limitation, institutional review boards, the FDA, Health Canada, the European Medicines Agency and the U.K. Medicines and Healthcare Products Regulatory Authority;
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Health Regulatory Authority means any Governmental Authority administering, overseeing, or regulating any certificates of need and other licensure and regulatory approvals required for the operation of the Facility (including any approvals required to obtain reimbursement under Medicare, Medicaid and CHAMPUS, and other Department of Veterans Affairs benefits, as applicable.)
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Examples of Health Regulatory Authority in a sentence

  • The Annex I of the "National Health Regulatory Authority (NHRA) Clinical Trials Regulations", published in 2016, provides standards and requirements for Independent Research Ethics Committee (IREC) involved in clinical trials in Bahrain.

  • AstraZeneca shall have the right, at its sole discretion, to submit or de-list any Licensed Patent with respect to any Health Regulatory Authority without prior notice to or approval from Ardelyx.

  • Researchers are reminded that all research involving human subjects must have the relevant Health Regulatory Authority (HRA) approvals including Research Ethics Committee when appropriate, and that all clinical research requires a sponsor, which can be either the Trust or University.

  • The Schedule of Events and Statement of Activity approved by the Health Regulatory Authority details all related costings for the SWHSI-2 trial.

  • Exhale shall inform and consult with Schering prior to each regulatory submission to the Health Regulatory Authority, provided however, that prior to and following Regulatory Approval or Orphan Drug Approval, Exhale shall be solely responsible for interactions with Health Regulatory Authority.

  • Verified?Office use only # Item (explain in detail) Y Approval of these plans and specifications by this Health Regulatory Authority does not indicate compliance with any other code, law, or regulation that may be required—Federal, state, or local.

  • Accessed 30 December 2020.[3] National Health Regulatory Authority (NHRA).

  • This may include audit of the results required to comply with a Department of Health, Regulatory Authority, NTW or other quality assurance request  The transfer of records will be documented and monitored.

  • Upon first acceptance for filing of the Product NDA in the Field by the Health Regulatory Authority 7,000,000 [***] [***] [***] [***] [***] [***] Exhale shall notify Schering promptly in writing of the occurrence of any of the above milestones.

  • The DISC Trial is funded by the Health Technology Assessment Programme (Project Number: 15/102/04) The Schedule of Events and Statement of Activity approved by the Health Regulatory Authority contains all related costings for the DISC Trial, specifically:  Research Costs - the costs of the R&I itself that end when the research ends.


More Definitions of Health Regulatory Authority

Health Regulatory Authority means EMEA, the national competent authorities of the EU member states, FDA and any other government entity that has jurisdiction to grant Regulatory Approvals, including, but not limited to, Marketing Authorizations, for the Product in the Territory.
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Health Regulatory Authority means the Governmental Bodies authorized under applicable Laws to protect and promote public through the regulation and supervision of medical products, including, without limitation, Health Canada, the United States Food and Drug Administration, the European Medicines Agency and similar regulatory agencies having jurisdiction over the Corporation or its activities;
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Health Regulatory Authority means Health Canada;
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Health Regulatory Authority means any provincial, state, federal or foreign Governmental Entity that has jurisdiction over or responsibility for (i) the safety, efficacy, approval, possession, development, testing, labeling, packaging, manufacturing, fabrication, storage, marketing, promotion, sale, commercialization, shipment, import, export, sale or distribution of any health products, including biological products, blood products, controlled or scheduled substances, drugs and pharmaceuticals, medical devices, radiopharmaceuticals, and vaccines, (ii) the safety or regulation of drug establishments or health, laboratory, specimen-collection or patient-care facilities, (iii) the activities or conduct of health or healthcare professionals or personnel, (iv) payment or reimbursement for any health or healthcare services, including diagnostic tests and specimen collections, (v) any other regulated health or healthcare activities of the Acquired Entities or (vi) quality control, standards assessment or accreditation of any of the foregoing. For greater certainty, “Health Regulatory Authority” includes Health Canada, the Canadian Office of Controlled Substances, the Public Health Agency of Canada, the Canadian Food
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Health Regulatory Authority means as Authority constituted by Government under section 20 for the purposes mentioned in the said section;
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Related to Health Regulatory Authority

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

  • 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.

  • 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.

  • Regulatory Authorities means the Commissions and the Exchange;

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

  • 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.

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

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

  • 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;

  • 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.

  • 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;

  • 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.

  • 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).

  • MFDA means the Mutual Fund Dealers Association of Canada;

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

  • Regulatory entity means any board, commission, agency,

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • 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.

  • Health Authority means the regional health board designated under the Health Authority Act, RSBC 1996, c.180, or the Provincial Health Services Authority, to which the Participant is designated under Schedule 1 (Return of Service Placement Process) of this Contract, unless designated otherwise by the Province;

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

  • 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.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Regulatory Law means the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all other federal, state and foreign, if any, statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • Regulatory Laws means all Applicable Laws governing (i) the import, export, testing, investigation, manufacture, marketing or sale of the Product, (ii) establishing recordkeeping or reporting obligations, (iii) any Field Action or (iv) similar regulatory matters.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

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Most Referenced Definitions