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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 ...
However, in the European Union, after one renewal, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise. [ 3 ] If the marketing authorisation is not renewed in due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The Act authorizes several subsidiary organizations, including the Bhutanese Drug Regulatory Authority, Drug Testing Laboratory, and teams of Drug Inspectors. These agencies have rulemaking and law enforcement authority on drugs, medicines, and even price controls, but must operate within the laws of Bhutan. [14]
The Ministry of Health was one of the first 13 Ministries of the Provisional Revolutionary Government of the Democratic Republic of Vietnam, [2] [3] [4] established on August 28, 1945 [5] and introduced to the people for the first time on September 2, 1945. The first Minister was Doctor Pham Ngoc Thach.
Bhutan: Royal Monetary Authority of Bhutan: Bolivia: Autoridad de Supervisión del Sistema Financiero (ASFI) Bosnia and Herzegovina: Central Bank of Bosnia and Herzegovina ; Securities Commission of the Federation of Bosnia and Herzegovina (KOMVP) Botswana: Bank of Botswana ; Non-Bank Financial Institutions Regulatory Authority (NBFIRA) Brazil
The health bureaucrats pursued this agenda again in October, at the International Conference of Drug Regulatory Authorities (ICDRA), and again in December 2012 at the Heads of Medicines Regulatory Agencies Summit. "As a result, a consensus has emerged on the desirability of developing an ICMRA to address common issues." [3]
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: