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The review process of the European Medicines Agency regarding medical issues has been criticized for its lack of transparency. [18] In a rebuttal of an EMS review that included her work, Louise Brinth, a Danish physician, noted that "experts" reviewing data remain unnamed and seem to be bound to secrecy.
Ministries of health in several sub-Saharan African countries, including Zambia, Uganda, and South African, were reported to have begun planning health system reform including hospital accreditation before 2002. However, most hospitals in Africa are administered by local health ministries or missionary organizations without accreditation programs.
This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.
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 ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
Due to the near-universal desire for safe, effective, and high quality healthcare, there is a growing interest in international healthcare accreditation. [1] Providing healthcare, especially of an adequate standard, is a complex and challenging process. Healthcare is a vital and pervasive issue; it influences all aspects of societies.
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
Within the Council of Europe, the EDQM's mission is to contribute to the basic human right of access to good quality medicines and healthcare, and to promote and protect human and animal health by: establishing and providing official standards for the manufacture and quality control of medicines in all the signatory states of the Convention on ...