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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 PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
Mutual recognition is a cornerstone principle in the Area of freedom, security and justice (AFSJ) in the European Union (EU). The importance of mutual recognition as a key principle for promoting cooperation, coordination and trust among EU Member States within the AFSJ has been firstly recognized in the Tampere Conclusions, adopted by the European Council in October 1999.
Invacare Corporation Reaches Agreement with FDA on Terms of Consent Decree, Subject to Approval of United States District Court ELYRIA, Ohio--(BUSINESS WIRE)-- Invacare Corporation ...
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Engineers from Britain and the United States have struck a mutual recognition agreement of industry qualifications and licences which is set to make it easier for professionals to work on either ...
The International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA) is an agreement for the mutual recognition of accredited certification between IAF Accreditation Body (AB) Member signatories. This agreement allows for the acceptance of accredited certification in many markets based on one accreditation.
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.