11.120.10 - Medicaments

This document specifies the quality and safety requirements of Rheum root and rhizome (the dried root and rhizome of Rheum palmatum Linne., Rheum tanguticum Maxim. ex Balf. and Rheum officinale Baill.). This document applies to Rheum root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processing methods and processed products of Rheum root and rhizome.

This document specifies the minimum requirements and test methods for Coptis rhizome (the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.). This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processed Coptis rhizome, including products traditionally processed with different methods, or its processing methods.

This document specifies minimum requirements and test methods for root of Scutellaria baicalensis, which is derived from cultivated Scutellaria baicalensis Georgi. This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the business requirements for the structured content of structured or semi-
structured dose instructions for recording dose instructions in the electronic health record (EHR),
supporting clinical decision support, and in exchanging medication orders, as applicable to primary,
secondary and tertiary care.
This document is focused on the dose instructions as will be presented to the individual subject of care
or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching
consideration for subject of care safety and the best outcomes. Related factors are discussed but are not
part of the primary scope.
This document does not define an information model, except to the extent that those information model
concepts are necessary to define business requirements.
Outside the scope of this document are:
— The implementation of dose instructions, i.e. assembling the structured elements into a form
appropriate for the patient or caregiver;
— The content of a medication order (see ISO 17523) beyond content related to dose instructions;
— The content of a record of dispense of a medicinal product (see ISO/TS 19293);
— The functionality of health, clinical and/or pharmacy systems;
— Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole
process of health care providers, such as:
— A drug knowledge database (see ISO/TS 22756);
— A decision support system (see ISO/TS 22756 and ISO/TS 22703);
— A complete medical record (EHR);
— A medicinal product dictionary (see ISO/TS 19256);
— Verification of the medicinal product and dose being administered.
— Some concepts from Identification of Medicinal Products are referenced, but not defined, in this
document. See Clause 4 for discussion of the relationship of this document with IDMP.

This document specifies the determination of ochratoxin A (OTA) in natural products by the liquid chromatography coupled with fluorescence detector (LC-FLD) method. It is applicable to the analysis of OTA in raw materials and manufactured products, including decoction pieces derived from plants and animals. It is suitable for samples during the processes of harvesting, transportation and storage, as well as domestic and foreign trade for quality classification.

This document specifies the testing of preservatives and unwanted compounds within a quality control framework for starting materials and finished products used in and as traditional Chinese medicine.

This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).

This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw materials and finished products used in traditional Chinese medicine.

This document specifies the quality and safety requirements of Saposhnikovia divaricata root and rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk. It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the content of electronic labelling in the form of QR codes on the outer packing of Chinese materia medica and decoction pieces. This document is applicable to the cultivation, production, sales, use units and consumers of Chinese materia medica and decoction pieces.

This document specifies the requirements for process traceability systems in Chinese materia medica and decoction pieces, including checkpoints of traceability information about the planting or breeding and circulation of Chinese materia medica, and the manufacturing, processing and use of entities of decoction pieces.

This document specifies the minimum quality and safety requirements of Sinomenium acutum stem [the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.]. This document applies to Sinomenium acutum stem that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.

This document specifies the minimum requirements and test methods for white peony root derived from the plant of Paeonia lactiflora Pallas. It is applicable to white peony root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. It is not applicable to red peony root.

This document specifies the minimum requirements and test methods for Codonopsis pilosula root derived from the plant of Codonopsis pilosula (Franch.) Nannf. It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies minimum requirements and test methods for Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root. This document applies to Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

This document specifies the method for the determination of benzopyrene content in processed natural products. It is applicable to processed natural products such as processed Rehmannia root, processed Cyperus rhizome, processed ginseng and processed mume fruit. It is not applicable to the analysis of minerals used in traditional Chinese medicine.

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

This document specifies the requirements for medication safety alert systems and the topics which are
relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs)
whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;
— requirements for choosing a knowledge base for medication safety alert systems;
— requirements for the proper functionality of CDSSs as related to medication safety alert systems;
— requirements for medication safety alert display;
— requirements for quality measurements to improve the effectiveness of medication safety alerts.
The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.

This document specifies the quality and safety requirements of Zingiber officinale rhizome derived from the plant Zingiber officinale Roscoe, including the minimum requirements and test methods. This document applies to Zingiber officinale rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. It is not applicable to Zingiber officinale rhizome sold and used as food or spices.

This document specifies test methods to determine microorganisms in natural products. It is applicable only to natural products used in traditional Chinese medicine, including raw materials, herbal pieces and preparations.

This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived from the plant Glehnia littoralis Fr Schmidt ex Miq. This document applies to Glehnia littoralis root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the general requirements and test methods for herbal raw material and materia medica. This document provides minimum requirements for those herbal materials that are not covered by individual standards.

This document specifies minimum requirements and test methods for processed Aconitum carmichaelii lateral root (lateral root of Aconitum carmichaelii Debx.). This document applies to processed Aconitum carmichaelii lateral root that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. Processing methods of Aconitum carmichaelii lateral root are excluded.

This document specifies a method for using high-performance liquid chromatography (HPLC) to determine the presence of aristolochic acid I in natural products.

This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.

This document specifies general requirements within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms, and the comparison between the starting materials and the finished products, if necessary.

This document provides a referenced entry-level implementation template for traditional Chinese medicine decoction piece prescriptions based on HL7 CDA® Release 2.0 to support the data collection, transmission, storage and exchange of decoction piece prescriptions for electronic records. This document focuses on the description of core data of traditional Chinese medicine decoction piece prescriptions which constitute the 'medication administration' section of the clinical document body. This document does not specify the detailed content of the clinical document header or other sections and entries of the clinical document body.

This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

This document specifies the minimum requirements and test methods for Lycium barbarum and Lycium chinense fruit, which is derived from the plant of Lycium barbarum L. or Lycium chinense Mill. It is applicable to Lycium barbarum and Lycium chinense fruit that is sold and used as herbal raw materials in the international trade, including unprocessed and traditionally processed materials.

This document specifies the methods for the determination of aflatoxins (AFB1, AFB2, AFG1, AFG2) in natural products using LC-FLD. It is applicable to the analysis of aflatoxins in raw materials and manufactured products, including decoction pieces derived from plants and animals.

This document specifies methods for the determination of the selected Aconitum alkaloids, including aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl-yunaconitine and crassicauline A.

This document specifies the method of determination of pesticide residues in natural products used in traditional Chinese medicine (TCM) by gas chromatography (GC), including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants.

This document specifies the methods for microscopic examination of medicinal herbs. It covers the equipment, sampling, preparation and observation methods. This document is applicable to medicinal herbs used in traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants. It is not applicable to medicinal materials derived from animals or minerals.

This document specifies a method using photostimulated luminescence (PSL) to detect the radiation status of natural products. It can be used to identify whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured product made from these materials have been irradiated by ionizing radiation (gamma, X-ray or beam). It is not applicable for use in testing liquid dosage forms or partially solid extracted dosage forms that do not contain directly crushed medicinal materials.

This document specifies the quality and safety requirements of Astragalus mongholicus root [root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao]. This document applies to Astragalus mongholicus root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document provides a reference of single herbal medicines in order of their priority in the development of international standards.

This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.

This document specifies the minimum requirements and test methods for Salvia miltiorrhiza root and rhizome, which is derived from the Salvia miltiorrhiza Bge. plant. It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.

This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the minimum requirements and test methods for Isatis indigotica root derived from the plant Isatis indigotica Fort. It is applicable to Isatis indigotica roots that are sold as Chinese material medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies minimum requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.

This document gives names for crude drugs used in Kampo formulae with concepts (or definitions) that are designated by the names to ensure safety and to facilitate international trade, including source materials and intermediate products/materials. Those names are aligned with the names for both the intermediate products and the medicinal products that are manufactured in accordance with the definitions and/or designs. This document is applicable to crude drugs "as concepts (or definitions)" used in Kampo medicine. This document excludes the following: — individual manufactured drug names for medicinal products "as things" derived from crude drugs; — medicinal materials (Materia Medica) "as things", or traditional medicines that are not regulated by the Japanese Pharmacopoeia or the related official documents published by the Medicinal Regulatory Agency, the Ministry of Health Labour and Welfare of Japan.

This document specifies requirements for a record of a dispense of a medicinal product.
It is intended to be adopted by detailed, implementable specifications, such as interoperability
standards, system specifications, and regulatory programs.
This document applies to information systems in which a dispense of a medicinal product is registered,
and the systems that consume such information. These systems are usually in pharmacies or other
healthcare institutions. This document does not necessarily apply to non-pharmacy shops or other nonclinical
systems (e.g. supermarket cashiers).
The scope of this document includes the activities relating to the dispensing of a medicinal product and
the information content for the capture of structured information produced in those events.
These activities include any actual dispense, cancellation or other outcome that may have occurred at
the time of planned or actual dispense. In other words, the dispense record also contains information
that medication was expected to be dispensed but was not dispensed.

This document specifies rules to encode formulae, and gives specific codes for 1 233 frequently-used formulae. Chinese patent medicines (CPM) are outside the scope of this document. Kampo formulae are outside of the scope of this document. This document is applicable to formula-relating databases in fields of clinical medication, scientific research and teaching, electronic medical records and prescription of traditional Chinese medicine (TCM).

ISO 15378:2017 specifies requirements for a quality management system when an organization:
a)    needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b)    aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1    In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2    Statutory and regulatory requirements can be expressed as legal requirements.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

ISO/TR 23022:2018 specifies the controlled vocabulary for formulas used in Japanese Kampo medicine with the therapeutic indications of each product according to the subset of IDMPs (ISO 11238, ISO 11615, ISO 11616[10], ISO 19844[15], ISO/TS 20443[16], ISO/TS 20451[17]). ISO/TR 23022:2018 is intended to be used by: - traders and distributors of medicinal products in Kampo formulas and crude drugs used in Kampo medicine; - terminologists and developers of new terminological resources concerning herbal medicines in Kampo medicine, and maintenance officers of existing terminological resources concerning Kampo medicine to enable their conformance; - informaticians, developers, or managers of HIS, EMR, or EHR systems concerning Kampo medicine; - officers, analysts or maintenance personnel of national health statistics, and policy proposal staff of national health policies; - officers of WHO, and WHO statistics. This edition of ISO/TR 23022:2018 describes only medicinal products in accordance with the Kampo formula in Japan. Both OTC Kampo formula medicinal products and in-pharmacy formula medicinal products are omitted, although they are permitted under Japanese jurisdiction. Topics considered out of scope of this document are: - any medicinal products manufactured in accordance with the formula of traditional medicines that are not permitted under the Japanese jurisdiction; - whole information models of medicinal products, pharmaceutical products and substances (see ISO 11238) because those are already specified in IMDPs; - any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115[13] and EN 12264[18]). The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.

ISO 19617:2018 specifies the general requirements for manufacturing processes to ensure the quality of finished products used in traditional Chinese medicine (TCM). This document covers premises, documentation, personnel, training, manufacturing control and quality control. This document applies to the manufacturing of natural products used in and as TCM. ISO 19617:2018 does not conflict with general pharmaceutical good manufacturing practices (GMPs). ISO 19617:2018 applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.

This document is intended to provide specific levels of information relevant to the identification
of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and
relationships between data elements that are required for the exchange of regulated information, in
order to uniquely identify pharmaceutical products. This identification is to be applied throughout
the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In
addition, this document is essential to ensure that pharmaceutical product information is assembled
in a structured format with transmission between a diverse set of stakeholders for both regulatory
and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and
compatibility for both the sender and the recipient.
This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is
a formal association of particular data elements categorised in prescribed combinations and uniquely
identified when levelling degrees of information are incomplete. This allows for Medicinal Products to
be unequivocally identified on a global level.
References to other normative IDMP and messaging standards for pharmaceutical product information
are included in Clause 2, to be applied in the context of this document.
Medicinal products for veterinary use are out of scope of this document.