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IDMP IN THE SPOTLIGHT
BALANCING COST AND VALUE IN
APPROACH TO IMPENDING STANDARD
The pharmaceutical industry is gearing up to tackle another significant and widely
encompassing set of standards: Identification of Medicinal Products (IDMP). The
purpose of IDMP is to provide an international means of describing drug products
for registration as either authorized or investigational medicines. It specifically
provides explicit identifiers for the product, package and batches to improve safety
monitoring, but it has other wide-reaching benefits as well.
While IDMP has been talked about at a high level for some time (work has been
going on for years at Health Level 7 to develop the Common Product Model that
forms its core, and it was approved as a set of ISO standards in 2012), it wasn’t until
2014 that the industry had a clear delivery date. As of July 2016, IDMP will be a
requirement in Europe. The United States and Japan — the two other members of
the International Conference on Harmonisation (ICH) — will follow suit, and more
than likely other countries will also adopt IDMP. If the United States follows past
practice, it’s likely to allow 2 years from when the guidances for the five IDMP
standards are issued before it makes IDMP a requirement.
IDMP will ultimately replace the Extended EudraVigilance Medicinal Product
Dictionary (XEVMPD) in Europe and the Electronic Drug Registration and Listing
System (eDRLS) in the United States. While there are commonalities among the
three systems, IDMP is a far more comprehensive set of standards and will require
significant time and financial investment on the part of pharmaceutical companies.
IDMP comprises five standards: the Medicinal Product (MPID); the Pharmaceutical
Product (PhPID); Substance and Specified Substance; Dose Form, Route of
Administration, Unit of Presentation, and Package; and Units of Measurement.
Data for IDMP is drawn from multiple sources across the enterprise.
The questions companies have been asking are: In terms of time and resources,
how much will they need to invest in preparing for IDMP? And, beyond the obvious
compliance requirement, what is the business value of a more comprehensive
approach to IDMP? First, though, they will need to determine what needs to be
done, even at the barest minimum, to prepare for IDMP.
Category
Source
Owners
Medicinal Product
Regulatory Knowledge, RIM System
Global/Local Regulatory Affairs
Pharmaceutical Product
Regulatory Knowledge, RIM System
Global/Local Regulatory Affairs
Marketing Authorization
Regulatory Knowledge, RIM System
Global/Local Regulatory Affairs
Packaged Product
Labeling/ERP Systems
Supply Chain/Commercial
Clinical Particulars
Regulatory Knowledge, Labeling,
Pharmacovigilance, Clinical
Pharmacovigilance, Regulatory Affairs,
Clinical (development products)
Substance Information
CTD Module 3, Quality Systems
Regulatory CMC, Manufacturing
Establishments
Regulatory Knowledge, RIM, ERP Systems
Regulatory CMC, Manufacturing
Exhibit 1: Where Does IDMP Data Come From?
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IDMP IN THE SPOTLIGHT: BALANCING COST AND VALUE IN APPROACH TO IMPENDING STANDARD
PREPARING WHILE YOU WAIT
When the European Medicines Agency (EMA) announced the XEVMPD in
September 2011 for implementation by July 2012, the timeframe seemed challenging
enough. In the end, the final version of the standard was not available until March
2012, just 4 months before deadline. Perhaps not surprisingly, the XEVMPD records
had an enormous number of errors, and in January 2014, the EMA announced that
between June 16, 2014, and December 31, 2014, marketing authorization holders
(MAHs) would have to resubmit every single XEVMPD record to correct errors and
to add a few new data fields.
IDMP has the potential to become another rush job if it is done without proper
forethought and preparation by the industry. One of the challenges is the rapidly
changing state of the requirements. Finalized specifications from Europe aren’t due
until December 2015, which leaves just 6 months to implement a solution and submit
data to the agency.
In one positive development, the EMA expects to have draft guidance in June 2015,
earlier than a previous estimate of summer 2015.
The short timeframe between final issuance of guidance and the requirement to
comply means that vendors will need to prepare services, software, and related
training and implementation services based on the draft guidance, with anticipation
of fixing any differences at the last minute.
For companies, the emphasis needs to be on gathering data, establishing processes
and standard operating procedures, and making decisions on how information will
be managed and stored.
CONFRONTING CHALLENGES
One of the goals of IDMP is to establish international dictionaries for a wide variety
of controlled vocabularies (e.g., dose forms, units of presentation and routes of
administration; standard identifiers for substances; and standard identifiers for
organizations), which would mean that a company that is manufacturing at a plant in
India can use the same identification number if filing in the United States or in Europe.
The challenge, however, is that the organizations to manage those vocabularies don’t
exist yet. There are projects underway to build those entities, and they are expected
to be in place in time for implementation of IDMP, but there is limited time to have
everything in place.
The second issue around the vocabularies is that the terminologies may vary
from region to region. Europe may benefit by being the first out of the gate with
implementation, and be able to control what those terms are. So while it makes
sense to register the controlled vocabularies for substances just once, since these
are descriptive and don’t cover the authorization for use, the list of terms for things
such as route of administration or dosage form may not be the same. For example,
will it be referred to as “injection, intramuscular” or “intramuscular injection”? Or will
there be more detail, such as “intramuscular injection arm,” “intramuscular injection
thigh,” and so forth? In other words, what level of detail will route of administration
include, and what exactly will the terminology be?
The current U.S. drug listing is submitted using the Structured Product Labeling
(SPL) standard. The SPL standard uses 150 terms for dosage form (tablet, solution
for injection, etc.), and XEVMPD has 450, with only about 40 matching exactly.
While most of the U.S. terms likely map directly to a European term, the wording is
slightly different. It is hoped that IDMP will get one-to-one mappings from the local
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IDMP IN THE SPOTLIGHT: BALANCING COST AND VALUE IN APPROACH TO IMPENDING STANDARD
to the international term, but this remains unknown at this stage. It could present
some difficulties if a local term could be one of many international terms, as in the
example above with intramuscular injection.
IDMP Potential Benefits
nnSimplify systems
nnImprove patient compliance
A VALUE PROPOSITION
A further frustration for many in the industry is the perception that time and
resources have been invested in XEVMPD, and in resubmitting data before the end
of 2014, only to have it replaced less than 2 years later by another standard.
nnStreamline manufacturing
nnReduce dosing errors
nnPrevent counterfeits
An estimate from the European Federation of Pharmaceutical Industries and
Associations (EFPIA) puts the cost of XEVMPD across 14 companies that provided
data at more than €28 million ($30.4 million), with a conservative forecast of
another €38 million ($41.5 million) across those same companies to switch to IDMP.
In an October 2014 positon paper aimed at the EMA, EFPIA notes that while
the industry recognizes IDMP as an opportunity for information consistency,
the standards have a major impact on stakeholders. EPFIA made several
recommendations on the implementation of IDMP, including that there should
be a clear definition of business value.
Certainly it can be argued that XEVMPD has provided some benefits to companies:
Requiring them to know what products they hold and where their data resides has
given companies insight into what marketed products they have at the local
affiliates — information that in the past was often obscured at the headquarters,
only fully available to local affiliates.
This broad view of the portfolio was made possible because of the effort involved
in gathering data: In order to submit in XEVMPD format, companies needed to
centralize distributed information and, in the process, compare the versions from
various countries and make them consistent. The very act of gathering data, whether
conducted in house or through a service provider, created an opportunity to manage
and track that information, which could enable companies to exploit markets that
may have been overlooked, and, in turn, improve supply and delivery chains.
IDMP has the potential to provide even greater benefits to companies, including:
1) the potential to simplify systems through a centralized and standardized
approach; 2) the opportunity to improve patient compliance and safety with
global databases of contraindication and drug interactions; 3) the ability to
streamline manufacturing and supply with clearer information about the product
and substance; 4) fewer dosing errors, which would result in fewer lawsuits; and
5) product identifiers to make it harder for counterfeits to get onto the market and
to hasten withdrawals, thereby lowering costs associated with such issues.
A STEPWISE APPROACH
One of the big unknowns about IDMP has been exactly what sponsors will be
required to submit.
IDMP has been described by an FDA official as an “aspirational, not operational
standard.” It has everything the regulatory authorities would ever want to describe
the registration of a medicinal product, although there is currently a request at
Health Level 7 to enhance the Common Product Model to support additional
European requirements for market authorization changes. This means the standard
should be future-proof. In other words, there should be no need to change the
standard. But how much needs to be implemented now?
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IDMP IN THE SPOTLIGHT: BALANCING COST AND VALUE IN APPROACH TO IMPENDING STANDARD
Requirements vs. XEVMPD
Regulated
Document
Country/
Language
Interactant
Interactions
Medicinal
Product
Classification
Version
Manufacturer/
Establishment
(Organisation)
Medicinal
Product
Name
Other Therapy
Specifics
Marketing
Authorisation
Procedure
Medicinal
Product
Pharmaceutical
Product
Marketing
Authorisation
Application
Periodic Safety
Update Report
Submission
Marketing
Status
ContraIndication
Therapeutic
Indication
Marketing
Authorisation
Holder
(Organisation)
Marketing
Authorisation
Undesirable
Effects
Clinical
Particulars
Population
Specifics
Medicines
Regulatory
Agency
(Organisation)
Manufacturing
Operation
Device Batch
Identification
Packaged
Medicinal
Product
Batch
Identifier
Device
Nomenclature
Device
Shelf Life/
Storage
Data Carrier
Identifier
Package Item
(Container)
Route of
Administration
Pharmaceutical
Product
Characteristics
PhPID Set
Device Batch
Identification
Other
Characteristics
Package
(Component)
Manufactured
Item
Specified
Substance
Ingredients
New Requirement
Physical
Characteristics
Substance
Expanded
Reference
Strength
Same or “merely”
remapped
Strength
*International Standard ISO 11615. First Edition. 2012-11-01
Exhibit 2: What Might Be Required by Full ISO*
The ISO guidance that has been released talks about how to compose the data
for the entire standard. So there is plenty of information on how to send an IDMP
registration, but very little on what content has to go in it. Is it necessary to
completely specify packaging? Is it necessary to send indications, contraindications,
drug interactions and adverse events? Currently, for example, Europe only requires
indications be sent in an XEVMPD submission — the rest of those clinical particulars
aren’t required.
In its paper, EFPIA called for staged implementation, noting that it should be “driven
by success and experiences allowing for the processes and systems to mature and
for the stakeholders to gain an understanding prior to any expanded rollout or
requirements.” The organization also called for the data scope to be the same as
what exists in XEVMPD.
That would now seem to be the intent of the authorities. Information that emerged
from the EU IDMP Task Force meeting in early April 2015 shows the agency plans
to implement the same data that currently exists in XEVMPD, with the addition of
whatever is needed to specify all IDMP identifiers. In other words, it would appear
that companies will need to provide a little more packaging information to specify
package identifiers, and they may need to provide a little more product data in
order to create the pharmaceutical product IDs and medical products IDs.
Interpreting the announcement, the implication is that the EMA’s goal is not to
burden sponsors any more than necessary. The agency appears to be asking for
the minimum necessary for IDMP, but will likely ask for more data in another year.
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IDMP IN THE SPOTLIGHT: BALANCING COST AND VALUE IN APPROACH TO IMPENDING STANDARD
Nevertheless, it remains unknown how much work will be involved in gathering
additional information for IDMP. Nor will it be a one-size-fits-all exercise. Rather,
it will vary significantly depending on the complexity of the product suite, whether
companies file centrally (which likely means they would have only one version of
the label), whether they have separate packages for languages, whether there are
different trade names in various countries, and how many products are involved. For
example, a company with 400 different medicinal products marketed in each EU
state, with packages in different languages, could face a massive workload. For such
a company, there would be thousands of pieces of packaging information for those
hundreds of IDMP records.
A large amount of relevant data previously was only found in unstructured sources,
such as documentation, as opposed to it being structured system data. Therefore,
it isn’t going to be as simple as pressing a button and getting a report out of an
existing system. Data will exist in multiple places; some of it will be in the supply
chain system, and some of it will have to be gathered from clinical documentation
and the regulatory submission information. All that data will have to be extracted
and made ready for IDMP.
The other consideration is whether an incremental approach is really in companies’
interests. Deciding to put off further changes until they are absolutely necessary
means that software will continue to change, tools will have to change and
companies will have to repeat the effort of gathering information on a regular
basis until the authorities say they are satisfied.
GETTING AN EARLY START
Given the burden companies are facing and the likelihood that the regulators will
stagger the adoption of IDMP, the challenge will be to decide how much work to
do now and how much to put off. It’s a matter of weighing cost against benefit.
It may be worth trying to gather more of that master data, more information about
each product — how it’s manufactured, how it’s used, how it shouldn’t be used —
now, even if it isn’t necessary for IDMP right away. By getting that information into
a Regulatory Information Management (RIM), Master Data Management (MDM) or
IDMP-specific system, companies will be able to use the information to improve
the whole regulatory process. Full compliance may also require deciding between
duplicating manufacturing and Enterprise Resource Management (ERM) data in the
IDMP system, or creating direct interfaces into those other systems.
Currently, much of that information is distributed not only across documentation, but
also across geography. In many companies — particularly larger organizations — the
local affiliate manages information for each country, meaning the official version from
which data needs to be extracted will be in each affiliate company, in each market.
What companies need to consider is whether to centralize the data management
process, so that once information has been filed by the affiliate company to the local
authorities, it is held in a central system. At the very least, that information needs to
be centralized for the purpose of assembling the IDMP submission. But IDMP presents
the opportunity to have in place an MDM system or RIM system that is the definitive
source of information, giving companies a clear overview of their products across
all markets. In other words, the decision to adopt an MDM philosophy — where
information is stored in one place — allows companies to gain a single, holistic
source of truth.
In the coming years, regulators will seek more consistent information from
companies to improve management of patient safety. At the same time, taking a
comprehensive or MDM-style approach to IDMP has several benefits for companies.
Having consistent data from a single source of truth prevents mistakes; it allows
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IDMP IN THE SPOTLIGHT: BALANCING COST AND VALUE IN APPROACH TO IMPENDING STANDARD
them to manage the product life cycle more efficiently; and it gives them broader
knowledge of their own information and global product portfolio. Having deeper
knowledge of what products exist around the world will allow companies to
penetrate new markets, expand sales channels in existing markets, compare what’s
happening in different countries, and reach new customers. It’s an opportunity to
access markets that companies didn’t know were available to them.
Today’s challenge is to determine the value of initiating full IDMP data collection
and integration versus incremental steps matching agency requests.
ABOUT THE AUTHOR
Joel Finkle is Advisor, Emerging Practices with CSC’s Life Sciences BPS group.
You can follow his blog at Life Sciences Regulatory Technology.
About CSC
CSC is a global leader in next-generation IT services and solutions. The company’s mission is to enable superior returns on
our clients’ technology investments through best-in-class industry solutions, domain expertise and global scale. For more
information, visit us at www.csc.com.
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