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Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care? – June 13, 2019

Автор: U.S. Food and Drug Administration

Загружено: 2020-01-17

Просмотров: 5062

Описание: Ron Fitzmartin, Larry Callahan, and TJ Chen from FDA’s CBER and CDER discuss FDA’s approach to adopting the five IDMP International Organization for Standardization (ISO) standards. They also discuss the goals, objectives, and timeframe for the development and implementation of the Global Substance Registration System’s (G-SRS).
The five standards include data elements and structures for identification for:
ISO 11615 - medicinal product information (MPID)
ISO 11616 - pharmaceutical product information (PhPID)
ISO 11238 - substances (Substance ID)
ISO 11239 - pharmaceutical dose forms, units of presentation and routes of administration
ISO 11240 - unique identification and exchange of units of measurement

Find more information at https://www.fda.gov/drugs/cder-small-...

_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

Email: [email protected]
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn:   / cder-small-business-and-industry-assistance  
Twitter:   / fda_drug_info  
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...

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Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care? – June 13, 2019

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