The document provides an overview of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. It discusses the origin and purpose of IDMP, which is to uniquely identify regulated pharmaceutical products across their lifecycle using standardized data. Key points include: - IDMP consists of 5 ISO standards and 4 implementation guides to define over 500 standardized data fields for describing medicinal products, substances, organizations, and controlled vocabularies. - Implementation will be phased and is intended to facilitate data exchange between organizations and regulators for activities like clinical trials, pharmacovigilance, and regulatory submissions. - Challenges to implementation include standardized structuring of existing unstructured data and linking product

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2. Index
• Origin of IDMP
• IDMP
• Implementation of ISO IDMP Standards
• IDMP Challenges
• IDMP Scope
• Background

3. Origin of IDMP

4. Origin of IDMP
Eudravigilance
launched 2001
•Voluntary
EVMPD
launched 2005
•Mandatory
EMA rebranded
the EVMPD to
be called
xEVMPD in 2010
Released
guidelines in
March 2012
Deadline for
xEVMPD
submission is
02Jul2012.
Quality issues
after 02Jul2012
New guidelines
for xEVMPD in
January 2014
IDMP 2016
2017

5. IDMP
• IDMP is a set of ISO guidelines that allows
definition, characterization, and unique
identification of regulated pharmaceutical products
across their lifecycle, from early clinical
development through marketing authorization,
ongoing management changes and ultimately,
withdrawal.
• Pharmaceutical and biotech companies will be
required to electronically submit detailed product
data and maintain it on ongoing basis.

6. IDMP
• ISO IDMP provides a unique opportunity for
the Pharmaceutical Industry to gain additional
benefits;
• Access and exchange of high quality, standardised master
data between different functions within the organisation
• Improve company effectiveness and provide
transparency to patients and consumers
• Strengthen communication with regulators by accessing
safety data
• Facilitate acquisition of other products or companies, as
data will be in the same format
• Improve identification of emerging product safety risks
via traceability of product information

7. IDMP
More than 500 data fields :Data fields helps in describing a
particular product, essentially everything,
• Clinical particulars
• Medicinal products
• Manufacturers
• Marketing authorizations
• Packaged medicinal products
• Pharmaceutical products
More Data Driven than xEVMPD

8. Implementation of
the ISO IDMP
standards

9. Phased approach to
IDMP
Implementation
The ISO IDMP standards
will be implemented in
phases, through a set of
projects known as SPOR
data management
services.
The SPOR data
management services are:
• Substance Management Services
(SMS)
• Product Management Services
(PMS)
• Organisations Management
Services (OMS)
• Referentials Management
Services (RMS)

10. SPOR Data
Management Services
Substance data
• Harmonised data and definitions
to uniquely identify the
ingredients and materials that
constitute a medicinal product
Product data
• Harmonised data and definitions
to uniquely identify a medicinal
product based on regulated
information (e.g. marketing
authorisation, packaging and
medicinal information)
Organisation data
• Data that comprises of
organisation name and location
address data for organisations
such as MAH, sponsors,
regulatory authority,
manufacturers
Referential data
• Lists of terms (controlled
vocabularies) used to describe
attributes of products e.g. lists
of dosage forms, units of
measurement, routes of
administration.
LIVE

12. Data Driven More than 1100 individual data
fields are relevant for IDMP.
Mandatory Fields
•300
Conditional Fields
•40
Optional Fields
•200
Undefined Fields
•560 (no applicable implementation guidelines at this moment

13. Implementation of
the ISO IDMP
standards

14. IDMP challenges
faced by MAH’s
• Most of the data is unstructured (data exists as
text with in product submission documents.
• Registrations between product documents and
global registrations are not effectively linked.
• Requires manually update.
• Complexity in data collection: Required IDMP
data may be owned by different departments
and functions.

15. Scope of IDMP
Using ISO IDMP in the Regulatory
Submissions
• Data submitted once can be re-
used – for example, information
provided as part of
authorization procedures can be
used as the pharmacovigilance
submission;
• Product and substance
information can be shared
across regulators.
Using ISO IDMP in the Clinical Trials
• Assessment and scientific
evaluation of a medicine is
improved by providing access to
data in a standard format.
• Allows proactive and reactive
access to CT data thereby
improving communication and
transparency.

16. Scope of IDMP
Using ISO IDMP in the Regulatory
Context
• Facilitating the identification and
exchange of product and
substance information globally,
across regulators;
• Enabling reuse of data across
different procedures and
regulators;
• Speeding up decision-making and
improving communication with the
stakeholders through easily
accessible and highly reliable data.
Using ISO IDMP in the Pharmacovigilance
• Once the IDMP standards are
fully adopted across
all ICH regions, it will enable
consistent data entry, resulting
in one harmonised database
which will enable regulators to
compare data across regions
consistently and also to trace
patterns of adverse drug events.

17. Background
Where does IDMP
come from?

18. Where does IDMP
come from?
• 5 ISO standards to uniquely identify a
medicinal product
• 4 Implementation Guides to bring theory into
real life
• Maintenance organisation(s) to assign unique
identifiers
• A set of control vocabularies and terms
• A messaging standard to exchange data

19. 19

20. ISO 11615 :
Medicinal Product

21. ISO 11615 :
Medicinal Product
• To define characterise and uniquely identify regulated medicinal To define,
characterise and uniquely identify regulated medicinal products during
their entire life-cycle
• Authorised Medicinal Products
• Investigational Medicinal Products
• To establish definitions and concepts
• To describe data elements and their structural relationships to uniquely
identify and describe medicinal products.
• To support the exchange of medicinal product information
• Use of other normative IDMP messaging standards
• e.g. HL7 Version 3 Standard, Common Product Model CMETs, DSTU Update Release 11
(currently under review)

22. ISO 11615 :
Medicinal Product
Medicinal Product
• Approved product is always as
packaged and Authorised by an
Agency in a Country.

23. ISO 11615 :
Medicinal Product
Concepts required for the unique
identification of medicinal
products
• Unique identification of medicinal products at international level, wherever required
• Pharmacovigilance ICSR PSUR Risk Management Pharmacovigilance, ICSR, PSUR, Risk Management
• Jurisdictions already have systems for issuing identifiers
• Marketing authorisation numbers, package identifiers, batch numbers, bar codes
• Additional identifiers defined by IDMP provide a harmonised indexing mechanism harmonised indexing
mechanism
• Supplementary to the existing systems NOT a replacement
• Unique Medicinal Product Identifier (MPID)
• to reliably recognise, monitor and trace the use of medicinal products
• Unique Medicinal Product package Identifier (PCID) Unique Medicinal Product Package Identifier (PCID)
• to reliably recognise and trace medicinal products as packaged for sale or supply
• Unique Medicinal Product Batch Identifier (BAID_1)
• to reliably recognise and trace a manufacturer’s batch number, which appears on the outer packaging of the medicinal
product
• Unique Medicinal Product Batch Identifier (BAID 2) Unique Medicinal Product Batch Identifier (BAID_2)
• to reliably recognise and trace a batch number on the immediate packaging.

24. ISO 11616 :
Pharmaceutical
Product ID

25. ISO 11616 :
Pharmaceutical
Product ID
Pharmaceutical product
• Pharmaceutical product is
always as administered.
• There can be more than one
Pharmaceutical product in an
Approved Medicinal Product

26. ISO 11616 :
Pharmaceutical
Product ID • PhPID will be assigned globally
• Similar products in Japan, EU, USA, Canada
will have the same PhPID
• To be assigned via an algorithm based upon
component IDs
• Active Ingredient
• Pharmaceutical Dose Form
• Strength (concentration where appropriate)
• All products will have a series of PhPIDs
• There may be more for products with more than one
active, or multiple manufacturers of actives

27. MPID - PhPID
Japan
Branded
Product
A
MPID 1
USA
Branded
Product
B
MPID 2
France
Branded
Generic
C
MPID 3
France
Generic
D
MPID 4
Germany
Generic
E
MPID 5
Germany
Generic
F
MPID 6
Canada
Branded
Product
G
MPID 7
Common
PhPID
Set
Note : Common for Substance but may be differences for Specified Substance
27

28. ISO 11238 :
Substances

29. ISO 11238 :
Substances
• Two categories of ‘Substance’
• Mono-disperse – Single molecular entity
• Poly-disperse – Multiple molecular entities
• Six groups of Substances
• Chemicals*
• Proteins*
• Nucleic acids*
• Polymers
• Structurally diverse substances
• Mixture subastance*
• E.g. Complex materials from biological matrices (e.g.
gentamicin which has three sub-types which do not get
separated out)

30. 30
use of G-SRS as the European repository
IDMP Code

31. ISO 11239 :
Vocabularies

32. ISO 11239 :
Vocabularies
• The standard is not the vocabularies – it is the
principles behind the vocabularies
• Implementation Guide will be used to create the
vocabularies
• EDQM (European Directorate for the Quality of
Medicines) terms will be used as the basis for ISO
11239 terms.

33. ISO 11239 :
Vocabularies
EDQM - European Directorate
for the Quality of Medicines
• The Standard Terms database contains terms
and definitions to describe pharmaceutical
dose forms, routes and methods of
administration, containers, closures,
administration devices and units of
presentation.
• It also contains patient-friendly terms, which
are generally shorter terms that, where
justified and authorised by the competent
authority, may be used on certain labels
where space is limited.

34. ISO 11240 : Units of
Measurement

35. ISO 11240 : Units of
Measurement
• The standard is not the vocabulary – it is stating that an existing
standard, that of UCUM will be used in this context
• UCUM is already used in Structured Product Labeling (for FDA) and
XEVMPD (for EMA)
What is UCUM
The Unified Code for Units of Measure (UCUM) is a code system
intended to include all units of measures being contemporarily used in
international science, engineering, and business.
The purpose is to facilitate unambiguous electronic communication of
quantities together with their units

37. Reference
• Presentation - EU IDMP Task Force meetings
• http://www.ema.europa.eu/ema/index.jsp?cu
rl=pages/news_and_events/events/2016/07/e
vent_detail_001309.jsp&mid=WC0b01ac05800
4d5c3

38. Thank you