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As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
Accreditation Association for Ambulatory Health Care (AAAHC) - based in the United States [51] American Accreditation Commission International (AACI) - based in the United States; Community Health Accreditation Program. [52] Det Norske Veritas (DNV) Global Healthcare Accreditation (GHA) [53] Healthcare Facilities Accreditation Program (HFAP) [54]
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 Health and Care Professions Council (HCPC), formerly the Health Professions Council (HPC), is a statutory regulator of over 280,000 [1] professionals from 15 health and care professions in the United Kingdom. The Council reports its main purpose is to protect the public.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
In a health plan, the credentialing process differs from that of a hospital. In a health plan, the provider enrolls in the provider panel network. After the application is submitted and credentials are verified, the approval process will involve review and approval by the network's medical director or credentialing committee.
Community Health Accreditation Program(CHAP) DNV GL Healthcare; Foundation for the Accreditation of Cellular Therapy (FACT) [4] Global Healthcare Accreditation (GHA) [5] Healthcare Facilities Accreditation Program (HFAP) Healthcare Quality Association on Accreditation (HQAA) Institute for Medical Quality (IMQ) Joint Commission (TJC)
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.