Search results
Results From The WOW.Com Content Network
Auditing of manufacturers to ensure they conform to Good Manufacturing Practice (GMP) and have a suitable Quality Management System (QMS) Post-marketing drug safety: The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices; Advising consumers on approved products
The Unique Ingredient Identifier ( UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA). It classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse ...
The Center for Drug Evaluation and Research ( CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.
The National Medical Products Administration is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China. [6]
application form that contains the following: (1) The name and address of the applicant; the date of the application; the application number if previously issued (for example, if the application is a resubmission, an amendment, or a supplement); the name of the drug product, including its established, proprietary, code, and
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 ...
COPENHAGEN (Reuters) -Doctors in Denmark should limit how many packs of Novo Nordisk's Ozempic diabetes drug patients can pick up at one time, the Danish Patient Safety Authority said on Monday ...
Synopsis. The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare ...