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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. All countries need an NRA. Countries manufacturing medical products need to exercise six critical control functions, and they need to exercise them in a competent and independent manner, backed up with enforcement power. Market Authorization and post-marketing surveillance and adverse events following immunization (AEFI) monitoring are functions that all NRAs have to establish regardless of the production capacity, procurement policy i.e.; vaccine locally manufactured, vaccine directly imported or imported through UN procurement agencies. WHO provides technical assistance for the development and implementation of NRA strengthening plans. Support to countries for assessment of their NRA functions is ongoing. Moreover, the Global Training Network on Vaccine Quality (GTN/VQ) is available to provide support in accordance with identified gaps and national plans.
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This article includes a list of general references, but it lacks sufficient corresponding inline citations. (August 2020) A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity.
These are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there is a lack of effective competition. Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India.
Regulatory agencies are generally a part of the executive branch of the government and have statutory authority to perform their functions with oversight from the legislative branch. Their actions are often open to legal review.
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). The existence of independent regulatory agencies is justified by the complexity of certain regulatory and directorial tasks, and the drawbacks of political interference. Some independent regulatory agencies perform investigations or audits, and other may fine the relevant parties and order certain measures. In a number of cases, in order for a company or organization to enter an industry, it must obtain a license to operate from the sector regulator. This license will set out the conditions by which the companies or organizations operating within the industry must abide.
Regulatory regimes vary by country and industry. In the most light-touch forms of regulation, regulatory agencies are typically charged with overseeing an industry, intervening only when there is a reasonable suspicion that a regulated company may not be complying with its obligations. Under such a regime, regulatory agencies typically have powers to:
In the event that the regulated company is not in compliance with its license obligations or the law, the regulatory agency may be empowered to:
In some instances, it is deemed in the public interest (by the legislative branch of government) for regulatory agencies to be given powers in addition to the above. This more interventionist form of regulation is common in the provision of public utilities, which are subject to economic regulation. In this case, regulatory agencies have powers to:
The functions of regulatory agencies in prolong "collaborative governance" provide for generally non-adversarial regulation.[1] Ex post actions taken by regulatory agencies can be more adversarial and involve sanctions, influencing rulemaking, and creating quasi-common law.[2] However, the roles of regulatory agencies as "regulatory monitors" provide a vital function in administering law and ensuring compliance.[2]
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What are the key functions of regulatory agencies?
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