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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.
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.
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 (NYS: IVC ...
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.
The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
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 1996, ILAC became a formal cooperation with a charter to establish a network of mutual recognition agreements among accreditation bodies that would fulfil this aim. [ 1 ] The ultimate aim of the ILAC is increased use and acceptance by industry as well as government of the results from accredited laboratories, including results from ...