Identification of Medicinal Products (IDMP):

What is IDMP and Why Should I Care?

Ron Fitzmartin, PhD, MBA
Sr. Project Manager
Review Management | Office of the Director
Center for Biologics Evaluation and Research (CBER) | FDA

Ta-Jen (TJ) Chen, MS

Project Management Officer
Office of Strategic Programs (OSP) | Center for Drug Evaluation and Research (CDER) | FDA

Larry Callahan, PhD

Global Substance Registration System (G-SRS) | Office of Health Informatics
Office of Chief Scientist (OCS) | FDA

FDA Webinar
June 13, 2019
Identification of Medicinal Products (IDMP) Update:

Ron Fitzmartin, PhD, MBA

Sr. Project Manager
Review Management | Office of the Director
Center for Biologics Evaluation and Research (CBER) | FDA

FDA Webinar
June 13, 2019
What is IDMP?
• IDMP is a suite of five standards developed (2012) within the International
Organization for Standardization (ISO) which will create an internationally-
accepted framework to uniquely identify and describe medicinal products.
• FDA is a member of ISO and has participated in the development of these
five standards.
• The 5 Standards include data elements and structures for identification for
– ISO 11615 - medicinal product information (MPID)
– ISO 11616 - pharmaceutical product information (PhPID)
– ISO 11238 - substances (Substance ID)
– ISO 11239 - pharmaceutical dose forms, units of presentation and routes of
administration
– ISO 11240 - unique identification and exchange of units of measurement
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 Potential Benefits of IDMP
Safety Surveillance
• Unambiguous global identification will improve pharmacovigilance by uniquely
identifying specific medicinal products in ICSRs.
• Globally detect safety signals from medicinal products referenced in adverse events.

Transparency
• Communicate medicinal product data globally.
• Opportunity to communicate and build trust with the public and other stakeholders
about medicinal product quality and safety.
Mitigation of Drug Shortages
• Standard allows us to identify pharmaceutically equivalent products across regions,
to support mitigation of drug shortages.
Interoperability
• Harmonized source for product information based on globally controlled vocabularies and
standards
• Support the exchange of medicinal product information between companies and regulators.
4
 FDA’s Approach to ISO IDMP Standards

ISO Medicinal Product U.S. National

Identification 01 01 ISO
11615 Drug Code (NDC)
11615

ISO Substance Unique Ingredient

Identification 02 02 ISO
11238 Identifier (UNII)
11238

ISO Units of Unified Code

03 03
03 ISO
11240 Measure for Units of Measure
11240
(UCUM)

ISO Dosage Form & FDA Terminology

Routes of 04 mapped to ISO
11239 04
Administration Central Terminology 11239

ISO Pharmaceutical Pharmaceutical

05 05 ISO
11616 Product ID Product ID
11616

5
 FDA IDMP Roadmap (1)
ISO 11615 ISO 11238 ISO 11240 ISO 11239 ISO 11616
Dosage Form & Pharmaceutical
Medicinal Product ID Substance ID Units of Measure
Route of Administration Product ID
• ISO publishes Standard • ISO publishes Standard • ISO publishes Standard • ISO publishes Standard • ISO publishes Standard
2012 • GSRS Project Initiated • UCUM conforms to
• UNII conforms to
ISO 11240
ISO 11238
2016 • EMA-FDA Collaboration

• Initiate evaluation of • GSRS in production • Initiate evaluation of FDA • Test FDA / Regional PhPIDs
NDC conformance Terminology for SPL
• Collaborate on FHIR
conformance
• NDC Conforms to Exchange Standard
2017 ISO 11615

• Determined FDA Terminology

• Periodic GSRS updates does not conform to ISO
11239
2018 • Analysis to assess mapping
to EDQM standard terms

• Determined mapping must be

• Continue collaboration with • Proposed meeting WHO /
• Collaboration to a central terminology
EMA on GSRS and FHIR • Planned update to the ISO TS UMC on PhPID validation/
with EMA on MPID FHIR maintenance
• Periodic GSRS updates 20440 and development of
2019 (development)
central terms

• ISO: International Organization Standardization • GSRS: Global Substance Registration System • NDC: National Drug Code • EDQM: European Directorate for
Quality of Medicines
9 June • UNII: Unique Ingredient Identifier • UCUM: Unified Code for Units of Measure • FHIR: Fast Healthcare Interoperability Resources
2019
6
 FDA IDMP Roadmap (2)
ISO 11615 ISO 11238 ISO 11240 ISO 11239 ISO 11616
Dosage Form & Pharmaceutical
Medicinal Product ID Substance ID Units of Measure
Route of Administration Product ID
• ISO publishes Standard • ISO publishes Standard • ISO publishes Standard • ISO publishes Standard • ISO publishes Standard
2012
• Continue collaboration • Periodic GSRS updates • Develop / identify central
with EMA on MPID FHIR terminology
• Continue collaboration
2020 (expect balloted in Jan) with EMA on GSRS & FHIR

• ISO: International Organization Standardization • GSRS: Global Substance Registration System • NDC: National Drug Code • EDQM: European Directorate for
Quality of Medicines
9 June • UNII: Unique Ingredient Identifier • UCUM: Unified Code for Units of Measure • FHIR: Fast Healthcare Interoperability Resources
2019
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 Identification of Medicinal Products (IDMP):
Update on
MPID, PhPID, SubID & Units

Ta-Jen (TJ) Chen, MS

Project Management Officer
Office of Strategic Programs (OSP) | Center for Drug Evaluation and Research (CDER) | FDA

FDA Webinar
June 13, 2019
 ISO
11615 Medicinal Product Identification (MPID)

• MPID Description
– Data elements and structures for unique identification and exchange of regulated
medicinal product information
• U.S. National Drug Code (NDC) is FDA’s regional MPID
– First two segments of the NDC code will be used to represent MPID

– The full NDC will be used to represent the medicinal product at the package level
(known as the PCID)
–Example: National Drug Code (NDC)

MPID = Labeler and Product Codes

9
 ISO
11615 Medicinal Product Identification (MPID)

ISO 11615:2017
8.2.1 General considerations
For each authorized Medicinal Product, a unique MPID shall be assigned. The MPID … supplementary to
any existing authorization number as ascribed by a Medicines Regulatory Agency in a region. This is … and
to contribute to improving patient safety by allowing for the unique identification of Medicinal Products
worldwide.
The MPID shall use a common segment pattern … define a specific MPID concept. The pattern is:
a) country code segment (ISO 3166-1 alpha-2 code elements);
b) marketing authorization holder (organization identifier) code segment; Labeler Code
c) Medicinal Product code segment. Product Code
Any change of the values related to these three code segments shall result in the assignment of a
new MPID.

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 ISO
11615 Medicinal Product Identification (MPID)

• ISO 11615:2017
3.1.41 marketing authorisation holder
– organisation that holds the authorisation for marketing a Medicinal Product (3.1.50)
in a region (3.1.73)

• CFR 21 Part 207 Subpart C—National Drug Code

§207.33 (c) Who must obtain an NDC labeler code …
– (1) Each person who engages in manufacturing, repacking, relabeling, or private
label distribution of a drug subject to listing under this part must apply for an NDC
labeler code , by providing …

11
 ISO
11615 Medicinal Product Identification (MPID)

ISO 11615:2017
8.2.2.4 Medicinal Product code segment
This code segment shall reflect a Medicinal Product code assigned to the Medicinal Product. It utilises defining
attributes to determine a single Medicinal Product to which a code is assigned. A different Medicinal Product code
segment shall be assigned, leading to a unique MPID, (subject also to the notes below) whenever any of the following
items of information for a Medicinal Product are modified, as applicable, per a Medicines Regulatory Agency
process(es):

a) marketing authorization in relation to the jurisdiction;

b) legal status of supply (e.g. prescription only or “over the counter” sale);
c) Medicinal Product name;
d) pharmaceutical dose form;
e) active ingredient(s)/active moieties and their corresponding strength;
f) device(s) where a Medicinal Product is combined with a medical Device;
g) therapeutic indication(s) as authorized for the Medicinal Product
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 ISO
11615 Medicinal Product Identification (MPID)

CFR 21 Part 207 Subpart C—National Drug Code

§207.35 What changes require a new NDC?
(b) The proposed new NDC must include a new product code when there is a change to any of the
following information:
(1) The drug's established name or proprietary name, if any;
(2) Any active pharmaceutical ingredient or the strength of any active pharmaceutical ingredient;
(3) The dosage form;
(4) A change in the drug's status, between prescription and nonprescription
(5) A change in the drug's intended use between human and animal
(6) The drug's distinguishing characteristics such as size, shape, color, code imprint, flavor, and scoring (if any).
(c) When there is a change only to the package size or type, including the immediate unit-of-use container
the proposed new NDC must include only a new package code and retain the existing product code unless
all available package codes have already been combined with the existing product code in NDCs assigned
by FDA.
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 ISO
11615 Medicinal Product Identification (MPID)

• MPID Exchange Standard (ISO/TS20443)

– ISO 11615:2017
• “This document has been developed in conjunction with the Common Product Model (CPM) and
Structured Product Labelling (SPL) in HL7.“
– FDA uses SPL (HL7 v3 message) for labeling and drug listing and registration
submissions, and does not currently have plans to change
• FDA determined that the MPID required components are captured in the SPL label
• Indication will be captured prospectively via regulatory submissions

– FDA is collaborating with EMA to develop and test HL7 Fast Healthcare
Interoperability Resource (FHIR) for information exchange
• Test will ensure adherence to the ISO (TS20443) technical specification, *and*
• FDA will evaluate and determine steps necessary to accept FHIR messages as well as SPL
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 ISO
11616 Pharmaceutical Product Identification (PhPID)

• PhPID Description - PhPID is a code generated by an algorithm based on

substance, strength, and dose form. PhPID can be used to associate
products with same or similar pharmaceutical composition.

PhPID_SUB_L1 → Substance Term(s) • FDA is currently testing the generation of

PhPID_SUB_L2 → Substance Term(s)+ Strength+ reference strength regional PhPIDs
PhPID_SUB_L3 → Substance Term(s) + Dose Form • In May 2018, WHO/ UMC presented a
PhPID_SUB_L4 → Substance Term(s) + Strength + reference strength conceptual proposal for validation and
+ Dose Form maintenance of global PhPIDs.
• Planning to participate at a technical and
policy working group meeting in August
2019.
NOTE 1 The substance(s) within the ingredient role “active” and
“adjuvant” is utilised to define the PhPID.

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 ISO
11238 Substance Identification (SubID)

• SubID Description
– Data elements and structures for unique identification and exchange of regulated
information on substances

• Unique Ingredient Identifier (UNII), ISO 11238 compatible, used by FDA for many
years to uniquely and unambiguously identify substances

• The Open Source Global Substance Registration System (GSRS) has been
developed and is available at https://tripod.nih.gov/ginas/#/
– FDA-GSRS is in production (approx. 180,000 entries)

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 IDMP on FHIR
• In January 2018, the EU endorsed* using FHIR as the basis for the API for
the Product Management Service
– Makes FHIR the data standard that supports the exchange of information about
medicinal products, substances, and related reference data in the EU
• HL7’s BR&R workgroup presently sponsors the development of ISO IDMP
11238 (Substance Specification) and IDMP 11615 (Medicinal Product)
resources
– Medicinal Product resource development takes place in collaboration with HL7’s
Pharmacy work group
– IDMP resources are expected to be balloted by January 2020 meeting

* https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-
data/substance-product-data-management-services
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 ISO
11240 Units of Measurement

• Units of Measurement Definition

– Data elements and structures for unique identification and exchange of units of
measurement

• The Unified Code for Units of Measure (UCUM) was selected as the ISO 11240
compliant standard
– UCUM is a system intended to include all units of measures being contemporarily used in
international science, engineering, and business

– Currently, FDA receives submissions that use the UCUM syntax standard for dosage strength
in both content of product labeling and drug establishment registration and drug listing.

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Identification of Medicinal Products (IDMP):
Update on
Dosage Form and Route of Administration

Ron Fitzmartin, PhD, MBA

Sr. Project Manager
Review Management | Office of the Director
Center for Biologics Evaluation and Research (CBER) | FDA

FDA Webinar
June 13, 2019
 ISO
11239 Dosage Form (DF) & Route of Administration (RoA)

• DF & RoA Description

– Data elements and structures for unique identification and exchange of regulated
information on pharmaceutical dose forms, units of presentation, routes of
administration and packaging

• Based on review of ISO 11239’s technical specification (20440:2016),

the terminology of the European Directorate for the Quality of
Medicines (EDQM) conforms to the ISO 11239 standard.
– European Directorate for the Quality of Medicines, under the authority of the
Council of Europe, maintains the terminology.
– EDQM terminology can be found at: https://standardterms.edqm.eu/

20
 ISO
11239 Dosage Form (DF) & Route of Administration (RoA)
• FDA Terminology for SPL is used in
– Content of drug and biologics labeling
– https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm
– Drug establishment registration and listing
– https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm
– CDISC controlled terminology for SDTM used in clinical trials
– https://www.cancer.gov/research/resources/terminology/cdisc

• National Cancer Institute / Enterprise Vocabulary Service (NCI /EVS)

maintains the FDA terminology as part of the larger NCI terminology
– https://evs.nci.nih.gov/ftp1/FDA/SPL/About.html

• Based on review of TS20440:2016 and analysis of EDQM, the FDA

Terminology for SPL does not conform to the ISO 11239 standard for
international IDMP.
21
21
 ISO
11239 Dosage Form (DF) & Route of Administration (RoA)

Mapping Results of FDA Terminology to EDQM PDFs

• FDA Terminology has 166

Pharmaceutical Dosage Forms (PDF)
FDA EDQM
• EDQM has ~484 PDFs 36
PDF
PDF Common
PDF
166 484
• FDA Terminology & EDQM share
36 common / mapped dose forms
22
 ISO
11239 Dosage Form (DF) & Route of Administration (RoA)

FDA Terminology Capsule Types Without a 1:1 Map to

EDQM Standard Term Capsule Types

23
 ISO
11239 Dosage Form (DF) & Route of Administration (RoA)

• If EDQM (standard terms) is considered the IDMP central terminology,

international PhPID Levels 3 and 4 may not be possible for some regions.

• For FDA, using EDQM, an international PhPID may not be possible for the
highlighted levels below:
1. PhPID_Substance Level_L1 → Substance(s) Term

2. PhPID_Substance Level_L2 → Substance Term(s) +Strength+ reference strength

3. PhPID_Substance Level_L3 → Substance Term(s) + Administrable Dose Form

4. PhPID_Substance Level_L4 → Substance(s) Term+ Strength + reference strength + Administrable

Dose Form
 ISO
11239 Dosage Form (DF) & Route of Administration (RoA)

• ISO TS 20440 Systematic Review Cycle

– As of 15 April, TS 20440 is scheduled for systematic
review cycle
– ISO ballot process underway to open for review:
August 2019
– If approved for systematic review, working group
formed to update the Technical Specification
20440.
– Goal: to ensure all parties can conform to a central
set of dosage form terms.

25
 Examples of EMA - FDA IDMP Collaboration
• Implementation of the EU Substance
EU National Registration System and Integration
Authorities
of GSRS and data exchange between
regions to support EMA and FDA
• Related to IDMP activities:
ICH applications.
• EWG E2B, ICH M2/M8 ISO
• eCTD • Implementation of the ISO IDMP suite
• CTD M2.3, 3 /PQ/CMC IDMP and information exchange between
the regions.
Collaboration
• Develop & disseminate
• Enhance, review and maintenance of
IPRP the ISO IDMP standards & technical
information on conformance to specifications via ISO/TC 215,
IDMP standards CEN/TC 251.
WHO
HL7
• Proposed maintenance of IDMP
• ISO IDMP underlying messaging global identifiers and terminology
infrastructure. FHIR resources for substance (substance IDs, PhPIDs, Org IDs,
and medicinal product via HL7 Biomedical etc.).
Research & Regulation workgroup (BR&R).
26 26
 Resources

https://www.fda.gov/industry/fda-resources-data-standards/identification-medicinal-products-idmp 27
http://www.iprp.global/home 28
Overview of Global Substance Registration System
(GSRS), Identification of Medicinal Products (IDMP)

Larry Callahan, PhD

Global Substance Registration System (G-SRS)
Office of Health Informatics
Office of Chief Scientist (OCS)FDA
 Outline of Talk
• Organizing Information
• IDMP Standard
• What is a substance
• GInAS/GSRS
• Status of Development
• Adverse Event Data

www.fda.gov 2
 Organizing Information
• FDA has the most important/valuable repository of human biological and product data but
limited integration.
– Submission process
• Paper
• PDF’s
– Organizational
• Different Centers
• Different Contractors
• Business Process
• The amount of information is increasing
– Rapid Screening Methods
– Enzyme and Receptor Profiling
• Cyp , Transporter and Receptor
– Genomics
– Epigenomics
– Electronic Health Records
– Many CMC changes
• Substances
– A key lynchpin for organizing scientific and regulatory information
– GSRS attempts to define substances consistently and unambiguously based on scientific principles
– UNII permanently assigned ties an identifier to actual entities independently of nomenclature

www.fda.gov 3
 Organizing Information
• Identification of Medicinal Products (IDMP)
– ISO project; 5 standards
• Approach of the IDMP to organizing information
– Goal is to get data organized prior to submission
– Fielded data is better than non-fielded Data
– Controlled vocabulary is better that non-controlled
vocabulary
– Codes are better than names in electronic systems
particularly relevant to substances
– Substance terminology on definitions (truth) not hierarchy
– All substances in medicinal products should be defined and
assigned a permanent unique ID

4
 Goals of IDMP Project
• Develop a common data structure and terminology for
the description of medicinal products
– Facilitate data exchange
• Pharmacovigilance
• Quality of pharmaceutics/detect/prevent counterfeiting
• Predict/prevent drug-drug food-drug interactions
• Incorporation of diverse data into databases
• Prevent drug shortages
• Promote Drug Development
– Consistent review
– Enter once use many (substances, organizations)
– Assist in mining of EHRs (Effectiveness. Safety, Better Dosing)
– Global ID for substances and pharmaceutical products (ie 200
mg ibuprofen tablets)
5
6

Global Health Benefits of IDMP

• Improve Pharmacovigilance
• Globally detect safety signals from medicinal
products referenced in adverse events

• Support Mitigation of Drug Shortages

• Allows the identification of pharmaceutically
equivalent products across regions

• Promote Greater Understanding and Sharing

• Supports the exchange of post-market medicinal product
information between companies and regulators

6
 What is a Substance: ISO 11238
• ARISTOTLE (Metaphysics)...the generally recognizable substances... are
the sensible substances, and sensible substances all have matter..., and
in another sense the formula or form..., and thirdly the complex of
matter and form, which alone is generated and destroyed, and is,
without qualification, capable of separate existence
• A unit of matter that can be quantitatively measured
• Five types of substances
– Chemicals, Proteins, Nucleic Acids, Polymers, and Structurally Diverse Material
– Mixtures

• Substance are not defined based on use

• The same substance can be manufactured or isolated using different
methods

7
 Substances (ISO IDMP)

• Five groups of elements are used to describe single substances.

– Monodisperse
• Chemicals
– Defined primarily by molecular structure (connectivity and
stereochemistry)
• Proteins
– Amino Sequence, type of glycosylation, modifications
• Nucleic Acids
– Sequence, type of sugar and linkage, modifications

8
 Substances (ISO IDMP)

• Polydisperse
• Polymers (Synthetic or biopolymers)
– Structural repeating units, type, geometry, type of copolymer
(block or random), ratio of monomers, modifications, molecular
weight or properties related to molecular weight, biological
source for many biopolymers
• Structurally Diverse Substances (viruses, cells, tissues, complex
materials)
– Taxonomic, anatomical, fractionation, physical properties,
modifications

9
 Why Register Substances
Need to tie substances to regulatory submissions

– Enhance review and drug development

• Active substance and inactive substances under review

• Biomarkers can be defined and tracked

• Use substances and related substance information to structure submissions
– Quality
– Manufacturing
– In-vitro data
– Clinical Information
» Clinical trial registration
» ICSR
• Starting materials
• Processing materials I
• Impurities
Need to tie substances to other substances

– Relationships between substances

• Active Moiety
• Salt/Solvate-> Parent relationships
• Metabolites
• Impurities
• Drug target
• Metabolic Enzymes (substrate, inhibitor, inducer)
• Transporters (substrate, inhibitor, inducer)
• Off target enzymes and receptors
www.fda.gov 10
 Why Register Substances?
Need to tie substances to products

– Quality perspective
• Change in substance can lead to a change in product
• Find all products that could contain a “bad” ingredient (heparin, diethylene glycol)
• Consistent specifications
– Safety perspective
• Track adverse events based on substances
• Tie substances to targets and pathways
– Drug Utilization
• Predict and prevent shortages
• Global marketplace need a global systems substances to manufacturer

Need to tie substances to manufacturer

– Quality
• Who makes it
• Where they make it
• How they make it
• Coordinate Inspections and testing

www.fda.gov 11
 Tie Substances to other Information
Need to tie substances to other information

– Quality – Clinical Pharmacology (LADMER)

• Characterization • Dissolution Data
• Specifications • Pharmacokinetics (Cmax, Tmax, Half-
• Stability life, Vd, etc.)
– Physical Properties • Metabolism
• Molecular weight • Excretion
• Solubility • Pharmacodynamics
• pKa or pKb – Health and Disease
• Partition coefficients • Indications (treatment, prevention,
• Polymorph (crystal, amorphous) causative)
– Toxicology and Animal Pharmacology • Adverse Events
• Genotoxicity • Drug-Drug Interactions
• Cellular Cytoxicity • Drug-Food Interactions
• Summary Animal Toxicology • Health Outcomes
– Acute , Subchronic and Chronic • - omics
• NOAEL, tissue distribution
• Environmental Fate
• Lab on a Chip results

www.fda.gov 12
 Need for Specified Substance
• Organize additional information on ingredients
(SSG1).
– Need to describe multiple substance ingredients
(Simethicone, Colorants, Flavors)
– Need to describe extracts (allergenic and herbal
extracts, tinctures)
– Need to distinguish materials that differ by physical form
or critical properties (Polymorphs, Flowability,
Compressibility)
– Just starting to implement this at FDA

13
 Need for Specified Substance
– Need to tie material to a manufacturer and a
process (SSG2 and SSG4)
– Need to tie material to a specific grade (SSG3)
– Need to obtain specification information (SSG4)
– Need to obtain information about processing
materials (SSG4)
– Need to establish and monitor the supply chain
(SSG2)
– Manufacturing and specifications were separated
out in ISO version 2
14
Specified Substance

15
 UNIIs, SPL, Orange Book, Purple Book,
Green Book, INDs
• GSRS currently implemented at FDA at the
substance level
• UNIIs are required for all ingredients listed in SPL
• Nearly all drug targets have UNII codes
• UNII codes assigned when INDs come in (CDER)
• Companies will eventually preregister or obtain
UNII shortly after submission
• UNIIs not explicitly listed in Orange Book, Purple
Book or Green Book
16
 What is the GSRS?
Assigns permanent UNII code to each substance

Compliant with the ISO IDMP Standard Ties substances to:

✓ Products Limited quality information

Registers and defines ✓ applications
(Integrity,
CFSAN and
GSRS)
✓ clinical trials ✓ Limited
(CT.gov and LADMER
EUCT) data
✓ Adverse (metabolites,
events counts cyp,
transporter
✓ Drug targets info)

www.fda.gov GSRS is part of the IDMP effort 17

18

GSR
S Global Substance Registration System

• Global marketplace for ingredients requires a global system to monitor

the global supply chain
• A Global Repository of Regulatory Information and Data on Ingredients
(Shortages, substandard and counterfeit ingredients, coordinate
inspections)
• Standard is complex, difficult and expensive to implement
• Data abstraction and curation is very expensive
• Global database means better data, less redundancy, more data, less
mapping

18
 GSRS is a Software Application
❑ Freely distributable (NCATS version, substance only)

❑ Predominantly open source

❑ Data accessed and entered through an API

❑ Backend Java, Oracle

❑ Works with Oracle, PostgreSQL, MySQL has built-in H2

database

❑ Has native JSON message can be adapted to HL7-FHIR

❑ UI development Angular 1.0, Scala, Play framework,

upgrating to angular 2.6

❑ Extensive use of Lucene Indexes

❑ Implemented Substance, Specified Substance Groups 1,

2, 3 and part of Specified Substance Group 4

❑ Excel tools for batch updating and queries

www.fda.gov 19
 How it’s used at FDA
• FDA has adapted GSRS to integrate with
existing internal databases and systems.
– Adverse events
– Products
– Applications (INDs, NDAs)
– Clinical Trials
• Industry uses the data from GSRS to find the
UNII codes for their substances, which are
submitted to the FDA.
– In the future, they will be able to create Active
Ingredient
a JSON message defining their substance
to the FDA
– Change submission process and eCTD
“Inactive”
Ingredients
21

GSR
S GSRS Software Current Status

• Works in all modern browsers: IE, Chrome, and Firefox

• System will be distributed with a large set of curated public domain data and
updated periodically
– Over 180,000 substances or concepts
– Over 900,000 names, 800,000 codes (CAS numbers, WHO-ATC, etc), 150,000 relationships
between substances (targets, metabolites, metabolic enzymes, transporters)
– Links to many outside resource (Chemid, Pubchem, Drug Bank, Orphan Drug etc)
– Mapped to both CTGOV and EUCT
– Structure and sequence based searching
– Faceted and advanced field-based searching
– Data downloadable in a variety of formats JSON, Text, Excel
– Attempts to tie indication-target-intervention

21
 Where we are going?

Jan 2021

Oct 2019
Develop and deploy
R applications for
Dec 2018 Deploy portal for direct substance based
Begin entering
substance registration for analysis
SSG1 data
industry and other regulators
Nov 2020
Jan 2020 – Nov 2020
Communication Procedures
UI development angular 6

Modify w/Integrity &

FAERS product
NCATS to Dictionary
distribute

Create robust Software updates to current

Nov 2019 version of SOLR
communications
procedures Jun 2019 Oct 2020

Modify internal process key milestones

Oct 2018 for substance
Develop distributable communication

Version of FDA software 22

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Working Collaboratively
 GInAS Meetings
• To get the software and data from NCATS
– https://tripod.nih.gov/ginas
• Meetings and Teleconferences
– Free and Open to Public
• To Get on the GInAS Notification List
– Sign-up at https://tripod.nih.gov/ginas
• NCATS Inxight Link
– https://drugs.ncats.io/
• NLM-FDA Link
– https://fdasis.nlm.nih.gov/srs/

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