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Rial applications for vaccines and Biologicals Guidelines for the Review & Evaluation Process of Applications for Clinical Trials of Vaccines & Biological medicines National Regulatory Authority of Country CONTENTS 1 Introduction 2 Definition of Terms and Abbreviations Check-list for documents in an Application 3 Procedures for Application submission and review 4 Institutional Review Board and/or Independent Ethics Committee 5 Amendments to Trial Protocol 6 Regulatory Authority Inspections 7 R.
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Characterisation FAQ
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Regulatory agencies deal in the areas of administrative law, regulatory law, secondary legislation, and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for the benefit of the public at large).
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(b) The term “regulatory function” means the making, prescribing, issuing, or promulgating of a regulatory order; and includes (1) determining whether such making, prescribing, issuing, or promulgating is authorized or required by law, and (2) any action which is required or authorized to be performed before, after, or ...
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A body that carries out regulatory activities relating to medicines, including the processing of marketing authorisations, the monitoring of side effects, inspections, quality testing and monitoring the use of medicines.
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Overview. NRAs are national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines and medical devices including test kits) are evaluated properly and meet international standards of quality and safety and efficacy.
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A WHO-Listed Authority (WLA) is a regulatory authority or a regional regulatory system which has been documented to comply with all the indicators and requirements specified by WHO for the requested scope of listing based on an established benchmarking and performance evaluation process.
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The purpose of regulatory agencies is to protect the public's health, safety, property, and overall interests. In most cases, this involves setting, enforcing, and publicizing licensing requirements, quality standards, and conduct rules across an industry.
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Regulatory agencies serve two primary functions in government: they implement laws and they enforce laws. Regulations are the means by which a regulatory agency implements laws enacted by the legislature.
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A stringent regulatory authority (SRA) is a national drug regulation authority which is considered by the World Health Organization (WHO) to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization.
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