|
Identification of Medicinal Products (IDMP) is a set of five ISO norms which has been developed in response to a world-wide demand for internationally harmonized specifications for medicinal products. IDMP provides the basis for the unique identification of medicinal products, it facilitates the activities of medicines regulatory agencies world-wide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products; pharmacovigilance and risk management). Messaging specifications are included as an integral part of the IDMP standards. They describe and protect the integrity of the interactions for the submission of regulated medicinal product information in the context of the unique product identification; they include acknowledgement of receipt including the validation of transmitted information. Health level Seven (HL7) Message Exchange are normative within the IDMP Standards. IDMP Standards are designed to allow unambiguous identification of products across regions to improve the robustness of pharmacovigilance and regulatory activities. they can also be applied to Investigational Medicinal Products. IDMP Standards are completed with Implementation Guides which are currently in development (2015). The standards can be found from ISO TC 215´s deliveries: http://www.iso.org/iso/home/store/catalogue_tc/ == The five ISO IDMP standards == 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Identification of medicinal products」の詳細全文を読む スポンサード リンク
|