Identification of Medicinal 
Products   
Implementation and Use 
 
Guidance for Industry 
 
 
 
  
 
    
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
  
 
March 2023 
Electronic Submissions 
   
Identification of Medicinal 
Products   
Implementation and Use 
 
 
Guidance for Industry 
 
  
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
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Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances     
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
  
 
March 2023 
Electronic Submissions 
  Contains Nonbinding Recommendations 
  
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION AND SCOPE ................................................................................. 1 
II.  THE ISO IDMP STANDARDS ................................................................................... 2 
A.  Substance Identification  ISO 11238 ................................................................................... 2 
B.  Dose Forms, Units of Presentation, Routes of Administration, and Packaging  ISO 
11239 ................................................................................................................................................... 2 
C.  Units of Measurement  ISO 11240 ....................................................................................... 2 
D.  Medicinal Product Identification  ISO 11615 ..................................................................... 3 
E.  Pharmaceutical Product Identification  ISO 11616 ........................................................... 3 
III.  BENEFITS OF IDMP IMPLEMENTATION AND USE ......................................... 3 
A.  Drug Safety and Pharmacovigilance Using Common Substance and Product 
Identification ...................................................................................................................................... 4 
B.  Medicinal Product Traceability for Global Supply Chain Integrity .................................... 4 
C.  Regulatory Registration and Exchange of Medicinal Product Information ....................... 4 
IV.  FDA APPROACH TO THE IDMP STANDARDS ................................................... 5 
A.  Unique Ingredient Identifier .................................................................................................... 5 
B.  SPL Pharmaceutical Dosage Form Terminology ................................................................... 6 
C.  Unified Code for Units of Measure .......................................................................................... 6 
D.  National Drug Code .................................................................................................................. 7 
V.  PHASED APPROACH TO GLOBAL IMPLEMENTATION ....................................... 7 
 
  Contains Nonbinding Recommendations 
  
Identification of Medicinal Products  Implementation and Use 
Guidance for Industry1 
 
 
This  guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To 
discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title 
page.   
 
 
 
I.  INTRODUCTION AND SCOPE 
 
This guidance is for sponsors, applicants, and registrants who are involved in the regulatory 
submission of medicinal product2 data. The guidance supports the development and 
implementation of the International Organization for Standardization (ISO) Identification of 
Medicinal Products (IDMP) standards for substances, terminologies, and other information for 
use throughout the global medicinal product development lifecycle.3 The purpose of these 
standards is to enable improved accuracy, completeness, and consistency in the international 
exchange of medicinal product information among stakeholders. 
 
The five IDMP standards, along with their corresponding technical specifications, were 
developed within the ISO network member organizations.4 The standards, initially published by 
ISO in 2012, provide a framework to uniquely identify and describe medicinal products with 
consistent documentation and terminologies to provide for the reliable exchange of product 
information between global regulators, manufacturers, suppliers, and distributors. This 
framework includes data models, terms, definitions, and some controlled vocabulary code lists. 
 
This guidance explains FDAs position and progress on aligning the Agencys standards to 
IDMP standards, which the Agency supports, to identify and describe marketed medicinal 
products with the exception of investigational medicinal products,5 with the goal of harmonizing 
the standards for the international exchange of medicinal product data. 
 
1This guidance has been prepared by the Office of Strategic Programs in the Center for Drug Evaluation and 
Research and the Center for Biologics Evaluation and Research at the Food and Drug Administration. You may 
submit comments on this guidance at any time.  Submit comments to Docket No. FDA-2017-D-6821 (available at 
https://www.regulations.gov/docket?D=FDA-2017-D-6821).  See the instructions in that docket for submitting 
comments on this and other Level 2 guidances. 
2 ISO 11615 defines medicinal product as ...any substance or combination of substances that may be administered 
to human beings (or animals) for treating or preventing disease, with the view to making a medical diagnosis or to 
restore, correct or modify physiological functions. However, for purposes of this guidance, medicinal product will 
be used as a general term to describe human drug, biologic, and combination products as defined in FDA statutes 
and regulations. Blood and blood components used for transfusion are excluded.  
3See https://www.fda.gov/industry/fda-resources-data-standards/identification-medicinal-products-idmp. 
4See https://www.iso.org/home.html. 
5See https://www.iso.org/standard/70150.html. 
 
  1  Contains Nonbinding Recommendations 
  
 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, 
but  not required 
 
II.  THE ISO IDMP STANDARDS 
 
A.  Substance Identification  ISO 11238 
 
The ISO 112386 standard specifies the data elements and structures for unique identification and 
exchange of regulated information on substances.7 It defines substances that are present in 
medicinal products in a scientifically consistent manner. The standard also includes information 
on specified substance levels, for example, grade, manufacturer, manufacturing, and quality 
information. The implementation of specified substance levels may depend on the type of 
substance and the particulars of a specific substance. 
 
B.  Dose Forms, Units of Presentation, Routes of Administration, and Packaging 
 ISO 11239 
 
The ISO 112398 standard specifies the data elements and structures for unique identification and 
exchange of regulated information on pharmaceutical dose forms,9 units of presentation, routes 
of administration, and packaging.   
 
Each pharmaceutical dose form has six associated characteristics  state of matter, basic dose 
form, release characteristics, transformation, intended site, and administration method. The 
characteristics allow for pharmaceutical dose forms to be more easily identified, and for related 
pharmaceutical dose forms to be identified together more easily and in different ways. The ISO 
11239 standard uses selected dose form characteristics for various use cases, such as global 
pharmaceutical product identification. 
 
C.  Units of Measurement  ISO 11240 
 
The ISO 1124010 standard defines the data elements and structures for unique identification and 
exchange of units of measurement. It specifies rules for standardized and machine-readable 
documentation of quantitative composition and strength of medicinal products; defines technical 
 
6 See https://www.iso.org/standard/69697.html. 
7 For purposes of this guidance, substance refers to the medicinal product ingredients and moieties. 
8 See https://www.iso.org/standard/55032.html. 
9 According to the ISO 11239 standard, the pharmaceutical dose form can refer to the administrable dose form or 
the manufactured dose form. The standard defines manufactured dose form as the pharmaceutical dose form of a 
manufactured item, and an administrable dose form as the dose form that is administered to the patient, with or 
without any transformation of the manufactured dose form. The terms dose forms and dosage forms are used 
interchangeably throughout this document.  
10 See https://www.iso.org/standard/55033.html. 
  2  Contains Nonbinding Recommendations 
  
specifications for representation of units of measurement in coded form; and provides structures 
and rules for mapping between different unit vocabularies and language translations. The 
standard also specifies that for electronic data exchange of units of measurement, a single 
common reference vocabulary should be used. 
 
D.  Medicinal Product Identification  ISO 11615 
 
The ISO 11615 specifies a unique Medicinal Product Identification (MPID) that is assigned 
regionally to each authorized medicinal product and can be supplementary to the existing 
authorization number.11 The standard also specifies the data elements and their structural 
relationships for unique identification and exchange of regulated medicinal product information. 
Data elements that identify and characterize a medicinal product include: 
 
  Medicinal product name12 (authorized by regulatory agency)  
  Clinical particulars (e.g., indications, contraindications) 
  Pharmaceutical Product (e.g., substance, dose forms, routes of administration) 
  Packaged medicinal product 
  Marketing authorization (e.g., authorization number, application information, Marketing 
Authorization Holder)  
  Manufacturer/establishment 
  Versioning (e.g., regulated documents by region) 
 
E.  Pharmaceutical Product Identification  ISO 11616 
 
The ISO 1161613 standard specifies the data elements and structures for unique global 
identification and exchange of regulated pharmaceutical product information. The 
Pharmaceutical Product Identifiers (PhPIDs) are generated using the following attributes to link 
similar products across regions: active substance(s), strength(s)/reference strength(s),14 and 
administrable dosage form(s). Global unique identifiers for the preceding attributes should be 
identified to enable the generation of global PhPID. 
 
III.  BENEFITS OF IDMP IMPLEMENTATION AND USE 
 
Medicinal products are important components of health care and having accurate information 
about these products is important to ensuring patient safety. The interoperability of information 
systems and standards across the healthcare sector is important to reduce the risk of errors in data 
entry and interpretation, and to facilitate the use of advanced analytics to identify global 
medicinal product safety issues, including potential counterfeit products across global markets.  
 
The IDMP standards should serve as common standards (for data elements and structure) for 
improved data sharing. These are internationally accepted standards for consistent 
 
11 See https://www.iso.org/standard/70150.html. 
12 Medicinal product name can be either an invented/trade name/proprietary name, a common/nonproprietary or 
proper name, a scientific name, or any other applicable descriptor. 
13 See https://www.iso.org/standard/70044.html. 
14 Reference strength is used as a reference from which the strength of a medicinal product is described. 
  3  Contains Nonbinding Recommendations 
  
documentation, coding, and exchange of product information among regulators, manufacturers, 
suppliers, and distributors. Further, their utility can be seen beyond regulatory purposes (e.g., in 
e-health records, and e-prescribing). 
 
A.  Drug Safety and Pharmacovigilance Using Common Substance and Product 
Identification 
 
Global adoption of the IDMP standards can improve both drug safety efforts and 
pharmacovigilance by uniquely identifying and uniformly exchanging the IDMP medicinal 
product and substance identifiers between regulators in Individual Case Safety Reports (ICSRs) 
using the International Council for Harmonisation (ICH) E2B(R3) format.15 As noted above, the 
use of the IDMP standards for ICSRs has potential to improve data quality and efficient 
processing by regulators, which may lead to improved accuracy of signal detection to associate 
adverse events and product quality defects to single or multiple products and substances globally. 
 
B.  Medicinal Product Traceability for Global Supply Chain Integrity 
 
IDMP identifiers contain information, including the proprietary name, common name (e.g., 
nonproprietary or proper name), pharmaceutical dose form, strength(s), package size(s), and 
batch identification of the medicinal product. These identifiers may provide for greater visibility 
of the supply chain and lead to improved traceability and supply chain integrity to help protect 
patients from receiving poor quality or illegitimate products, like counterfeits. 
  
C.  Regulatory Registration and Exchange of Medicinal Product Information 
 
The implementation and use of the IDMP standards should allow the identification and exchange 
of medicinal product information independent of registration origin. Some foreign countries 
operate under agreements that support the mutual recognition of product authorizations; 
therefore, it is beneficial to identify the same medicinal products authorized in different 
countries. Further, some countries may purchase medicinal products authorized by another 
regulatory authority and the full identity of those products may be unclear. The lack of clarity 
can also be problematic when one country requires marketing authorization/registration/licensing 
and another country does not. This is also problematic when a patient has a prescription from one 
country and wants to fill it in a different country. The implementation of the IDMP standards 
should provide more clarity in identifying pharmaceutically similar products across regions to 
support the mitigation of medicinal product shortages.  
 
 
 
 
15 See the guidances for industry E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) 
Implementatin Guide  Data Elements and Message Specification (April 2022); Appendix I (B) to the ICH E2B(R3) 
ICSRs Implementation Guide  Backwards and Forwards Compatibility (April 2022); and FDA Regional 
Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and 
Biological Products (April 2022).  We update guidances periodically. For the most recent version, check the FDA 
guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.  
  4  Contains Nonbinding Recommendations 
  
IV.  FDA APPROACH TO THE IDMP STANDARDS 
 
FDA supports the use of the IDMP standards to identify and describe medicinal products 
(excluding investigational medicinal products) and to facilitate the international exchange of 
medicinal product data. 
 
In 2013, FDA established an internal committee to determine the conformance of FDA standards 
to the ISO IDMP standards. Over several years, the committee analyzed the structure, format, 
and content of the Unique Ingredient Identifier (UNII);16,17 SPL (Structured Product Labeling) 
Pharmaceutical Dosage Form Terminology;18 Unified Code for Units of Measure (UCUM), and 
National Drug Code (NDC) 19 to assess their conformance to ISO 11238, ISO 11239, ISO 11240, 
and ISO 11615, respectively. FDAs internal committee determined that the Agencys standards 
conform to the ISO IDMP standards for regional use. For global implementation of ISO 11616 
(PhPIDs), global identifiers for substances and dose (dosage) forms will need to be defined. In 
the following sections, the FDA standards that conform to the ISO IDMP standards are 
discussed. 
 
A.  Unique Ingredient Identifier 
 
ISO 11238 substance identification provides an information model to define and identify 
substances within medicinal products or substances used for medicinal purposes. The ISO 11238 
standard identifies five types of substances: chemicals; proteins; nucleic acids; polymers; and 
structurally diverse materials, such as viruses, cells, and tissues (as well as mixtures). FDA has 
determined that the UNII code conforms to the ISO 11238 standard.  
 
The UNII is an alphanumeric identification consisting of nine randomly generated alphanumeric 
characters and a check character. The UNII code is permanently assigned to the substance and 
can be used to identify the substance in each medicinal product.  
 
Unique identification of substances20 should enhance the regulatory review of active and inactive 
substances in submissions and should facilitate an understanding of the relationships to other 
substances and products from a quality, safety, and medicinal product use perspective.  
 
FDA, in collaboration with the National Center for Advancing Translational Sciences 
(NCATS/National Institutes of Health (NIH)), has developed an ISO 11238-compatible Global 
 
16 See https://www.fda.gov/industry/structured-product-labeling-resources/uniis-preferred-substance-names-and-
their-identified-synonyms. 
17 See https://www.fda.gov/industry/fda-data-standards-advisory-board/fdas-global-substance-registration-system 
18 See 
https://thesaurus.cancer.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=21.04d&code=C5
4456&ns=ncit. 
19 See https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. 
20 The use of the term substance or substances in this guidance is intended to be synonymous with the terms 
component, active ingredient and inactive ingredient as defined in 21 CFR 210.3. FDA regulatory 
determinations related to complex substances are based on current Agency standards and may not align with 
international substance standards in some cases.    
  5  Contains Nonbinding Recommendations 
  
Substance Registration System (GSRS). The GSRS software21 and a public dataset are freely 
distributed by NCATS/NIH to enable companies and other interested parties to search for 
registered substances in the public domain and to identify substances in a manner consistent with 
ISO 11238.   
 
B.  SPL Pharmaceutical Dosage Form Terminology 
 
ISO 11239 specifies the data elements and structures for unique identification and exchange of 
regulated information on pharmaceutical dose forms.22 The standard does not specify that a 
region must map its dose form terms to a central terminology. FDA uses different dosage form 
terminologies for various use cases (e.g., SPL Pharmaceutical Dosage Form Terminology and 
United States Pharmacopeia (USP) Pharmaceutical Dosage Forms23).  
 
As stated in section II.E, substance, administrable dose form, and strength are inputs into the 
generation of the PhPID. However, there is no global central dose form terminology that can be 
used for global PhPID. FDA is collaborating with regulators, standards development 
organizations, and other stakeholders to develop and finalize a solution that uses pharmaceutical 
dose form characteristics, in addition to substance and strength, to generate the global PhPID. 
 
C.  Unified Code for Units of Measure 
  
ISO 11240 Units of Measurement specifies rules for the usage and coded representation of units 
of measurement for exchanging information about quantitative medicinal product characteristics 
such as strength. 
 
The Unified Code for Units of Measure (UCUM) is a terminology standard that provides a 
system of coding units of measurement used in international science and medicine.24 UCUM 
provides a single coding system for units of measurement that is unambiguous in electronic data 
exchange and assigns a concise meaning and definition to each defined unit code. It facilitates 
unambiguous electronic communication of quantities together with their units. UCUM is the ISO 
11240-compliant standard for units of measurement for most medicinal products.  
 
In September 2019, FDA announced the adoption of the most current set of the UCUM codes.25 
UCUM is the supported terminology standard and code system used for units of measurement in 
drug establishment registration and drug listing, and it is also recommended for use in the 
content of product labeling provided in regulatory submissions to the Center for Biologics 
Evaluation and Research and the Center for Drug Evaluation and Research.  
 
 
 
21 See https://gsrs.ncats.nih.gov/ and  https://precision.fda.gov/uniisearch. 
22 For the purposes of this guidance, the focus of the ISO 11239 standard is on dose (dosage) form. 
23  https://www.usp.org/ 
24 See https://ucum.org/trac/wiki/adoption/common. 
25 See the Federal Register notice, Electronic Submissions; Data Standards; Support for Unified Code for Units of 
Measure (84 FR 47308, Sep. 9, 2019), available at https://www.federalregister.gov/documents/2019/09/09/2019-
19346/electronic-submissions-data-standards-support-for-unified-code-for-units-of-measure). 
  6  Contains Nonbinding Recommendations 
  
D.  National Drug Code 
 
As discussed above, the ISO 11615 standard specifies a unique MPID that is assigned regionally 
to each authorized medicinal product and can be supplementary to the existing authorization 
number. FDA will continue to use the NDC as the unique identifier for U.S. medicinal products.   
 
The NDC is composed of a labeler code, product code, and package code. The concept and 
specifications to assign labeler code, product code, and package code are comparable with the 
ISO 11615 concept and specifications for Marketing Authorization Holder Code, Medicinal 
Product Code, and the Package Description Code. Adding the two-letter Geopolitical Entities, 
Names, and Codes (GENC)26 standard US country code27 to the NDC results in a code 
comparable to the ISO MPID. 
 
V.  PHASED APPROACH TO GLOBAL IMPLEMENTATION 
 
FDA is collaborating with various stakeholders, such as international standards development 
organizations (e.g., ISO, HL7 (Health Level 7 International)), regulatory agencies, and 
nongovernmental organizations to resolve issues that are impeding IDMP implementation 
beyond local or regional boundaries. FDA is working with these stakeholders to initiate and 
conduct projects leading to the establishment of a framework for the global implementation of 
the ISO IDMP standards and the maintenance of global identifiers. FDA intends for the 
framework to ensure that global PhPIDs and substance identifications are accessible to 
stakeholders for global drug safety and pharmacovigilance, global supply chain integrity and 
reliable exchange of product information, and that it will enhance the global availability of safe 
and effective medicinal products. FDA envisions that following the establishment of such a 
framework, global implementation of the IDMP standards should be conducted using a phased 
approach. 
 
Further guidance and/or technical specifications will be provided, as needed, for global 
implementation of the IDMP standards. 
 
26 See https://nsgreg.nga.mil/genc/discovery. 
27The two-letter GENC country code for US is the same as the two-letter ISO 3166-1 alpha 2 country code for US. 
  7