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• The various roles and responsibilities of regulatory authorities are as follows: 1. Regulatory authorities are responsible to review clinical trials of both non-registered medicinal substances and new indications of registered medicinal substances. 2. Regulatory authorities has a statutory obligation to ensure that the drugs available in the country fulfils the necessary requirements for safety, quality and
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BetaThe regulatory authorities are commonly set up to in order to enforce standards and safety, oversee use of public goods, and regulate commercial activities. To ensure that it does fulfill its role, a regulatory body uses mechanisms such as the following: • transparency of information and decision making • procedures of consultation and participation • requirement that administrators give reasons explaining their actions ...
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BetaRegulatory bodies are institutions set up to oversee and control specific sectors of the economy, ensuring fair practices and protecting public interests. In India, their role has evolved over time. Phase Description Pre-1991 Era (1947 to 1991) • • Government held strict control over the economy.
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BetaTelecom Regulatory Authority of India (TRAI) TRAI was established on 20 th February, 1997 by the Telecom Regulatory Authority of India Act, 1997. Functions of TRAI: Regulates telecom services, including the fixation and revision of tariffs, a responsibility previously held by the Central Government.
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BetaA Regulatory Authority is a government entity or agency accountable for implementing the rules and regulations in various sectors. It is among its functions to apply norms, restrictions, or limitations, establish the standard for operations, and enforce or ensure conformance in these areas. The following are the primary responsibilities of a ...
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BetaRegulatory bodies in India are government-established institutions responsible for overseeing, guiding, and controlling various sectors to ensure they operate within legal and ethical frameworks. These bodies play a crucial role in maintaining transparency, accountability, and fairness, fostering good governance and sustainable growth. ... Role and Composition of the Regulatory Board: The board should consist predominantly of non-executive members, ensuring independent oversight. It must ...
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BetaRegulatory authorities will have the overall responsibility to promote , ensureand monitor compliance by approved ethics committees in a country withrelevant legislation, regulations and guidelines including guidelines for GoodPractice in the Conduct of Clinical Trials in Human Participants in the country.
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Betafundamental responsibilities of the regulatory affairs profession. All medications must be of the highest quality possible and be safe and effective. The scientific and legal components of the New Drug Application (NDA), ... The National Regulatory Authority (NRA) in India is the Central Drugs Standard Control Organization (CDSCO). This is a part of the Directorate General of Health Services of India's Ministry of Health and Family Welfare. The
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BetaDuties and Responsibilities; Composition of Authority. Chairman and Members of Authority; Profile of Top Management; Member(Life)-Swaminathan S Iyer; Appointment Notification of Members; Regulations; Minutes of Authority Meetings; Organogram; Directory of employees; Address for communication; List of Holidays; Careers. ... Insurance Regulatory and Development Authority of India(IRDAI) is a statutory body set up for protecting the interests of the policyholders and regulating, promoting and ...
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BetaRegulatory authorities should obtain the required information at the least possible cost or burden to the regulatory authority and the service provider. Regulatory authorities must comply with the National Law when undertaking any ... Mutual responsibility Consistency and predictability. Regulatory authorities: • take a responsive regulatory approach when choosing the methods used
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