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Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014) standard is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences.
The International Financial Services Centres Authority (IFSCA) is the regulatory body for the Indian special economic zones such as the GIFT International Financial Services Centre for International Financial Services and commodity markets under the ownership of the Government of India. [ 3 ] It was established in 2020, under the International ...
t. e. The Office of Information and Regulatory Affairs (OIRA / oʊˈaɪrə / oh-EYE-rə) is a division within the Office of Management and Budget under the Executive Office of the President. OIRA oversees the implementation of government-wide policies in, and reviews draft regulations under, Executive Order 12866, the Paperwork Reduction Act ...
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