Global Ingredients Archiving System (GINAS)

What is GINAS in relation to ISO 11238

GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances.  GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP.

Background of GINAS

Globalisation presents tremendous challenges and opportunities for national regulatory agencies, the pharmaceutical industry, and global health as a whole. Emerging diseases and the health impacts of catastrophic events respect no national boundaries, nor does the increasing volume of substandard, contaminated, and counterfeit products that overburdens national regulators. Ingredients for pharmaceutical products are typically sourced on a global basis and it is very rare that all ingredients for a single product are produced within one jurisdiction. To regulate the global supply chain efficiently and to better respond to and prepare for catastrophic events it is essential to have a global information system for pharmaceutical ingredients.

ISO 11238 specifically addresses the identification and exchange of regulated information on substances. Working closely with that standard’s authors and regulatory authorities from various countries, NCATS is developing an information system to register and store substance-related information and provide identifiers. This will ensure a robust substance registration system that supports the additional needs of national and regional authorities and is consistent with the ISO 11238 standard. The system will support all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the system.

GINAS Project Description

The Global Ingredient Archival System (GINAS) represents a major opportunity for regulators worldwide to tackle the challenges of sharing ingredient information. This tool makes it possible to create a global standard for defining substances and a common identifier to identify ingredients in medicinal products. This will enable the global health community to share and use information to significantly improve health care delivery, the proper use of medications, and the management of risks involved in their use.

The project’s main goal is to provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation. It is envisioned that a consortium of regulators from different national and international agencies would operate and maintain the platform in a secure and trusted manner. This centralized database will result in higher quality data while still respecting confidentiality requirements.

The software tools used in this project are developed, maintained, and distributed to project members and other interested parties by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). As well as containing definitional information and identifiers, the system is able to store a wide variety of structured information on the identification, analysis, use, manufacture, pharmacology, and toxicology of medical product substances.

Goal of the Program

GINAS is a solution to the costly, duplicative, and piecemeal approaches currently being used. It will enable regulators to more easily monitor the global marketplace. The system could play a vital role in facilitating a global approach to pharmacovigilance; identifying and tracking substandard products and ingredients; alleviating drug shortages; enhancing clinical development; and coordinating and streamlining regulatory actions worldwide. The project will benefit industry by offering a “one-stop shop” to deposit substance-related regulatory information. It will help in developing specifications of substances and products in a more consistent manner, and in coordinating facility inspections. Finally, the project should dramatically reduce the time and costs of information-gathering for both companies and regulators.
NCATS intends this software product to be a freely distributable, maximally self-contained system to register substances and related manufacturing, analytical, and relevant biological information on substances that are of interest to health product regulators, product sponsors, and health researchers. Consistency will be achieved through a common data model and synchronization with a central database.
Since February 2013, Canadian, Dutch, German, Swiss, and U.S. regulators have been working with NCATS to create this system. Health Canada is providing an environment for collaborative development. This environment  supports the initial curation and mapping of content used for global substance identification.
The project group welcomes participation and sponsorship by regulatory agencies and other public health organizations throughout the world. It aims to be a global resource that will benefit public health by facilitating the transfer of regulatory information and providing industry and other interested stakeholders with a uniform process for depositing substance-related information.



IDMP Definition of Identification of Medicinal Products

IDMP defines the data elements and structures for the unique identification and exchange of medicinal products´ information.

Download here for free the “What is IDMP” PDF File

Iso IDMP Standards at a glance

IDMP Standards - What is IDMP?

ISO IDMP Standards

The set of fife ISO international standards has been developed by the ISO in response to a worldwide demand for internationally harmonised specifications for identification and description of medicinal products.

Article 40 of the new pharmacovigilance implementing measures legislation mandated the EMA to use the ISO IDMP standard latest by July 2016.

IDMP provides the basis for the unique identification of medicinal products, which facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products, pharmacovigilance, and risk management). They can also be applied to Investigational Medicinal Products.

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 completed with Implementation Guides which are currently in development (2015), as well as with Technical Specifications (TS) 16791 (provides guidance for the identification of medicinal products by using intenational supply chain Standards, securing traceability, safe supply chain and other market requirements) and Technical Requirements (TR) 14872 (Requirements for the implementation of the Standards for the identification of medicinal products for the exchange of regulated medicinal product Information), the latter being in development.

Implications for Marketing Authorisation Holders (MAHs)

In order to submit the data all branches of a company should share a common language, from pharmacovigilance to product supply to comply with the controlled vocabulary dedicated.
The structured substance information, and controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, and packaging will be challenging to integrate.
Furthermore the terminology needs to be aligned throughout the company.

You will find more details here


ISO 11238

Regulated information on substances (ISO 11238)
ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique Identification Number (ID).

Synonym and Abbreviations for Amlodipin (as example):
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester (IUPAC)
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate (WHO)
Amlodipin (ABDATA-SK)
Amlodipin (ABDATA-SK;ASK;INN.L25.D)
Amlodipine (BAN1999;DCF;INN.L25.E;INN.L25.F)
Amlodipino (INN.L25.S)
Amlodipinum (INN.L25.L)

Synonym Details:

Term Lang Role Code Type Source
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester N/A SY 1134301 SUB ABDATA
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate N/A SY 1134301 SUB ABDATA
Amlodipin DE ST C08CA01 ATC WHO
Amlodipin N/A PT 1134301 SUB ABDATA
Amlodipin DA ST SUB05467MIG SUB EMA
Amlodipin HR ST SUB05467MIG SUB EMA
Amlodipin HU ST SUB05467MIG SUB EMA
Amlodipin SK ST SUB05467MIG SUB EMA
Amlodipin SL ST SUB05467MIG SUB EMA
Amlodipine N/A PT SUB05467MIG SUB EMA
Amlodipine FR ST SUB05467MIG SUB EMA
Amlodipine N/A SY 1134301 SUB ABDATA
Amlodipine EN PT 1J444QC288 SUB FDA
Amlodipine EN PT C08CA01 ATC WHO
Amlodipino N/A SY 1134301 SUB ABDATA
Amlodipino ES ST SUB05467MIG SUB EMA
Amlodipinum CS ST SUB05467MIG SUB EMA
Amlodipinum LA ST SUB05467MIG SUB EMA
Amlodipinum N/A SY 1134301 SUB ABDATA

Other Properties:

Type Code Descr
ATC C08CA01 Calcium channel blockers
Selective calcium channel blockers with mainly vascular effects
Dihydropyridine derivatives
Contributing Source ABDATA WHO FDA FDB EMA
Semantic Type SUB ATC
CAS-Registry Number 88150-42-9
Molecular formula C20H25ClN2O5
Molecular weight 408,88

Synonym and Abbreviations:
Amlodipin benzolsulfonat (1:1)
Amlodipine besilate (BAN1999;BP)
Amlodipine besylate (USAN;USP)
Amlodipini besilas

Visit the IDMP Term Browser® with ISO 11238 data on Amlodipine Besilate in idmp1 (access restricted to registered users of the IDMP Term Browser®)


ISO 11239

ISO 11239 IDMP Standard lists regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.

The ISO 11239 standard identifies for example injection solution, injection suspension, infusion solution (or a less granular regional term linked to these.

Differences in granularity between regional terminologies
Many of the concepts covered in ISO 11239 are already described in various regions using their own sets of terminologies, which are usually not harmonised with those of other regions. This is often because of different levels of granularity between regions, which means that one-to-one mapping between those regions’ terms is not possible. For example, if the terms used in region A have a relatively low level of granularity compared to the terms used in region B, one term from region A will often map to several terms from region B. Indeed, the purpose of ISO 11239 is to allow for the development of a single set of controlled vocabularies that can be used by all regions to communicate with each other, and to which all regions can map their own regional terms.

The figure gives an example of how terms from Europe, the US and Japan might map to a list of central terms.

In this example:

  •  central terms distinguish between injection and infusion products but not between lyophilised and non-lyophilised powders;
  • Europe distinguishes between injection and infusion products but not between lyophilised and non-lyophilised powders (i.e. the same as the central terms);
  • the US distinguishes between lyophilised and non-lyophilised powders but not between injection and infusion products;
  • Japan uses a single term to describe all injection and infusion products.

As a result, with respect to the central terms there is one-to-one mapping for each European term, there is one-to-two mapping for each US term, and there is one-to-many mapping for the Japanese term.


iso 11239 mapping terms


ISO 11239 Screen from the IDMP Term Browser® for “capsule”:

Synonym and Abbreviations:


Synonym Details:

Term Lang Role Code Type Source
Capsule EN PT 12100 SYN EDQM
Capsule EN PT C25158 PHF FDA
Kapsel ET ST 12100 SYN EDQM
Kapsula SR ST 12100 SYN EDQM
Kapsulė LT ST 12100 SYN EDQM
Kapsulë SQ ST 12100 SYN EDQM
Капсула KK ST 12100 SYN EDQM
Капсули UK ST 12100 SYN EDQM

Other Properties:

Type Code Descr
Contributing Source EDQM FDA EMA
Semantic Type SYN PHF PAC PRE



ISO 11240

ISO 11240 – Units of Measurement

What ISO 11240 does:

  • specifies rules for the usage of units of measurement for IDMP
  • specifies requirements for traceability to metrological standards
  • establish reference code system for units
  • provide structures and rules for mapping between different unit vocabularies and language translations
  • linking to existing systems, dictionaries, and repositories

Strength of a medicinal product based on ISO 11240

In the case of strength given on a per dose basis, additional information on the characteristics of the countable dose item
may be required when comparing to strengths of other products.

EXAMPLE 1 Expression “per dose”: Total amount of substance per total amount of solution (200 mg of substance
contained in 10 ml of solution), total mass of ingredient contained in one single dose (500 mg of substance contained in
one tablet). Note that the description of the component (substance, solution, tablet) is not part of the unit of measurement.

EXAMPLE 2 Expression as intensive quantity: Mass concentration 20 mg/ml, activity content 5,000 IU/g.

EXAMPLE 3 Using the unit symbol “U”
The unit “U” of enzymatic activity was defined in 1964 by the International Union of Biochemistry as the
catalytic activity that catalyses the transformation of 1 µmol of the substrate per minute. Typical biological
enzyme activities are in the range of 1 U to 100 U. This unit of measurement can also be expressed explicitly
as “µmol/min”, where enzymatic activity is the property being addressed. Still, some arbitrariness is involved in
the definition of “standard conditions” (e.g. temperature, pH).

This unit denoted by the symbol “U” is not an arbitrary unit. In order to ensure traceability and avoid ambiguities,
it is important to discriminate this meaning against the frequently encountered usage of the same symbol “U”
for other (arbitrary) units. This is especially required to ensure unique meaning of codes used for information
exchange. “U” is assigned to enzymatic activity in the UCUM code system. However, the following description
uses the symbol “U” for a completely unrelated concept. Here “U” stands for an arbitrary unit that is defined
based on a “bioassay”:

e.g. Concentration 5 000 U/ml solution for injection.

Mapping between different unit vocabularies and language translations

ISO 11240 mapping table

ISO 11240 mapping table