ISO/TS 20443:2017 健康情報学—医薬品の識別—規制された医薬品情報の一意の識別と交換のためのISO11615データ要素と構造の実装ガイドライン | ページ 2

Foreword

ISO (the International Organization for Standardisation) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, 2 (see www.iso.org/directives ).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 215, Health informatics.

Introduction

This document is a guide for implementing ISO 11615, one of the five ISO IDMP standards. The five ISO standards and four ISO Technical Specifications, when used together, provide the basis for exchanging data elements that will support the unique and unambiguous identification of Medicinal Products. The primary purpose for this document is to provide technical guidance to software implementers. Short descriptions of business rationale are also included, where relevant, to provide context. Thus, this document focuses on business and technical considerations for implementation that will construct and parse well-formed, transmittable IDMP messages. Following transmission of required data elements, unique identifiers are to be produced in conformance with the standards to support applications where it is necessary to reliably identify and trace regulated biopharmaceutical products. However, this document does not include extensive information on creation or maintenance of identifier repositories. Reference is made to regional guidance/implementation guides to support practical implementation within a given region/jurisdiction. The development of an ISO technical report for identifying core principles for the maintenance of identifiers and terms for ISO IDMP is to be developed and referenced for applicable ISO IDMP standards and corresponding technical specifications.

Purpose

To meet the primary objectives of the regulation of medicines (pharmacovigilance) it is necessary to reliably exchange Medicinal Product information in a robust and consistent manner. The data elements and message specifications described in this document support, at a minimum, the following interactions within the following scope:

• regulator to regulator;
• biopharmaceutical company to regulator;
• sponsor of clinical trials to regulator;
• regulator to other stakeholders;
• regulator to worldwide-maintained data sources.

Unique identifiers produced in conformance with this document are aimed at supporting applications where it is necessary to reliably identify and trace the use of Medicinal Products.

In the context of exchange of regulatory information, the purpose of this document is twofold:

• to specify data elements, structures and relationships between the data elements which are required to uniquely identify Medicinal Products for human use;
• to specify definitions of terms for all data elements required to uniquely identify Medicinal Products for human use.

1 Scope

This document defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.

Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.

Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in this document to support successful information exchange.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography