GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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06:23 Apr 7, 2021 |
Russian to English translations [PRO] Medical - Medical: Pharmaceuticals / Drug Market Authorization Policies | |||||||
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| Selected response from: Frank Szmulowicz, Ph. D. United States Local time: 10:26 | ||||||
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Guide to organizing and formatting the registration dossier of a p. p. Explanation: (In my answer, p. p. stands for pharmaceutical product) Before a drug can be marketed, the regulatory agency has to approve it. The drug manufacturer has to submit a collection of documents (a dossier) that proves the drug's efficacy, safety, etc. The agency requires that the dossier be structured according to its guidelines. Example sentence(s):
Reference: http://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/... Reference: http://www.pharmatutor.org/articles/registration-dossier-pha... |
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General requirements for the modules of the drug registration dossier Explanation: http://regapharm.com/rules_registration_dossier_formation_ea... |
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reference book of the structural elements of a registration dossier of a medicinal product Explanation: On the classifier of types of documents for the registration dossier of a medicinal product and the reference book of structural elements of the registration dossier of a medicinal product https://www.russiangost.com/C-8173-8173-general-documents-on... https://www.russiangost.com/p-375698-decision-159.aspx |
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