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1、INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE D DRAFTRAFT C CONSENSUSONSENSUS G GUIDELINEUIDELINE D DATAATA E ELEMENTSLEMENTS ANDAND S STANDARDSTANDARDS FORFOR D DRUGRUG D DICTIONARIESICTIONARIES M5M5 Current Step 2 version date
2、d 10 May 2005 At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the three ICH regions (the European Union, Japan and the USA) for internal and external c
3、onsultation, according to national or regional procedures. M5M5 DocumentDocument HistoryHistory First Codification HistoryDate New Codification NovemberNovember 20052005 M5Approval by the Steering Committee under Step 2 and release for public consultation. 10 May 2005 M5 CurrentCurrent StepStep 2 2
4、versionversion M5Approval by the Steering Committee under Step 2 and release for public consultation. 10 May 2005 M5 i D DATAATA E ELEMENTSLEMENTS ANDAND S STANDARDSTANDARDS FORFOR D DRUGRUG D DICTIONARIESICTIONARIES DraftDraft ICHICH ConsensusConsensus GuidelineGuideline Released for Consultation o
5、n 10 May 2005, at Step 2 of the ICH Process TABLETABLE OFOF CONTENTSCONTENTS 1.1.INTRODUCTIONINTRODUCTION . 1 1 1.1.Objectives of the Guideline. 1 1.2Background . 2 1.3Scope of the Guideline . 2 2.2.GUIDELINEGUIDELINE . 2 2 2.1Medicinal Product and Term Identifiers. 2 2.1.1Medicinal Product Identifi
6、er (MedID) . 2 2.1.2Pharmaceutical Product Identifier (PhPID). 3 2.1.3Controlled Vocabulary Term Identifier (TermID).4 2.2Controlled Vocabulary . 4 2.2.1Background. 4 2.2.2Active Ingredients Controlled Vocabulary. 5 2.2.3Pharmaceutical Dose Form Controlled Vocabulary.6 2.2.4Routes of Administration
7、Controlled Vocabulary .7 2.2.5Units and Measurements Controlled Vocabulary.9 2.3Data Elements . 10 2.3.1Medicinal Product Identifier. 12 2.3.2Medicinal Product Administrative Section. 12 2.3.3Marketing Authorization Holder/Manufacturer/Distributor Section . 14 2.3.4Marketing Authorization Section .
8、15 2.3.5Pharmaceutical Product Section. 17 2.3.6Active Ingredient(s) Section. 19 2.3.7Pharmaceutical Dose Form Section. 22 2.3.8Route of Administration Section. 22 2.3.9Maintenance Section. 23 3.3.GLOSSARYGLOSSARY . 2525 4.4.REFERENCESREFERENCES. 2727 1 D DATAATA E ELEMENTSLEMENTS ANDAND S STANDARDS
9、TANDARDS FORFOR D DRUGRUG D DICTIONARIESICTIONARIES 1.1.INTRODUCTIONINTRODUCTION 1.1.1.1.ObjectivesObjectives ofof thethe GuidelineGuideline It is desirable for regulators and pharmaceutical industry to engage in an intensive information exchange during the drug development phase, the drug evaluatio
10、n and approval phase and the post-authorization phase. The standardization of medicinal product information is regarded as one of the key elements of this information flow. However, regulators in the ICH regions and observer countries have established their own procedures and applications with stand
11、ards that differ in data format, content, language and applied terminology (e.g., terminology used for active ingredients, routes of administration, pharmaceutical dose forms). Due to the lack of a common and harmonized approach, both regulators and pharmaceutical industry are confronted with the fo
12、llowing issues: -No possibility to exchange medicinal product information between regulators and industry in a structured and efficient way; -Difficulties in ensuring data consistency and in evaluating and comparing medicinal product-related information across the ICH regions due to the lack of harm
13、onized definitions of terminologies and data sets. This currently impairs pharmacovigilance activities in particular; -For the pharmaceutical industry, major administrative burdens and duplication of efforts requiring substantial human and financial resources to comply with and handle different regi
14、onal requirements; -Lack of consistency in the use of terminology in the health care community. The objectives of this guideline are to address the issues outlined above by developing harmonized standards that build on the processes currently established in the three ICH regions and the observer cou
15、ntries and to support the population of existing systems/applications with fully reliable regulatory medicinal product information. More specifically, the objectives focus on the development of: -UniqueUnique identifiersidentifiers at the level of Medicinal products: Medicinal Product Identifiers (M
16、edIDs); Pharmaceutical products: Pharmaceutical Product Identifiers (PhPIDs); The controlled vocabulary: Terminology Identifiers (TermIDs). -ControlledControlled vocabularyvocabulary as a standard for the electronic transmission of core sets of medicinal product information related to the following terminologies: Active ingredients; Pharmaceutical dose forms; Routes of administration; Units and measurements. -DataData elementselements for the electronic transmission of core sets of medicinal pro
