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The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
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.
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 business process to be supported can be described as follows: Industry <-----> Message <-----> Agency The lifecycle management is composed at least of: Initial submission: should be self-contained. Incremental updates: with its sequence number.
The chief medical advisor of Health Canada, Supriya Sharma, [14] [15] as of April 2021, oversees the COVID-19 vaccine approval process in Canada. [ 14 ] [ 16 ] On 29 March 2021, Sharma supported the National Advisory Committee on Immunization 's declaration of a pause for the administration of the AstraZeneca vaccine to Canadians under the age ...
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efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]
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]).
The Health Council of Canada was a national, independent, public reporting agency based in Toronto, Ontario, Canada. Announced as part of the 2003 First Ministers' Accord on Health Care Renewal with a mandate to report publicly to Canadians, the Health Council provided a system-wide perspective on health care reform related to the 2003 Accord’s policy and program commitments as well as those ...