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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]
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 ...
Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility ...
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.
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.
Health professional requisites refer to the regulations used by countries to control the quality of health workers practicing in their jurisdictions and to control the size of the health labour market. They include licensure, certification and proof of minimum training for regulated health professions. [1]
by health care providers to identify other health care providers in health care transactions or on related correspondence; by health care providers on prescriptions (however, the NPI will not replace requirements for the DEA number or state license number);
Unwarranted variation (or geographic variation) in health care service delivery refers to medical practice pattern variation that cannot be explained by illness, medical need, or the dictates of evidence-based medicine. It is one of the causes of low value care often ignored by health systems.