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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 Healthcare Facilities Accreditation Program (HFAP) is a not-for-profit organization meant to help healthcare organizations maintain their standards in patient care and comply with regulations and the healthcare environment. [1]
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Saudi Food and Drug Authority (SFDA) (Arabic: الهيئة العامة للغذاء والدواء) is an independent body for the Kingdom of Saudi Arabia that aims to ensure food and drug safety for the nation. The Authority was founded in August 29, 2003. [1]
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.
Among the many areas of practice represented in the CARF standards are aging services; behavioral health, which replaces institutional behavior management; psychosocial rehabilitation; child and youth services (with younger and established family services and support); durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS ...
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
HL7 International specifies a number of flexible standards, guidelines, and methodologies by which these healthcare systems can communicate with each other. The standards allow for easier 'interoperability' of healthcare data as it is shared and processed uniformly and consistently by the different systems.