On 15 December 2010, the European Parliament issued Regulation
No 1235/2010 amending earlier regulations 726/2004 and 1394/2007. Although this
regulation focused on pharmacovigilance, it also directed to set up and maintain a list of all medicinal products for human use
authorized in the EU and to comply with this regulation in 2012. The
regulation itself did not include any mandate about the format which needed to
be used and the EMA decided to use the Article 57 format or eXtended
EudraVigilance Product Report Message (XEVPRM) format to store date in Extended
EudraVigilance Medicinal Product Dictionary (XEVMPD).
On June 19, 2012 Regulation (EU) No 520/2012 was issued,
specifically stating reference to the ISO norms 11615, 11616, 11238, 11239 and
11240 as the terminology to be used for communication of pharmacovigilance and
medicinal product information. The implementation stated from July 1, 2016. This is how; ISO Identification of Medicinal
Product (IDMP) put forward as regulatory framework.
In light of the
above developments, the current Art57/XEVPRM format will be replaced with the
formats, terminologies and standards as defined by the ISO IDMP standards.
ISO IDMP Standard
was developed in response to a worldwide demand for internationally harmonized
specifications for Medicinal Products.
IDMP is a key
regulatory framework that developed under the umbrella of the ISO organization.
European region is the only one mandating compliance with IDMP at this point of
time but once the IDMP standards get adopted across different regions, it will enable
consistent data entry, thereby providing regulators the means to compare data
across regions for consistency, particularly in the case of global companies.
These standards
include a variety of regulatory activities related to development, registration
and life cycle management of medicinal products, as well as pharmacovigilance
and risk management.
So how XEVPRM works?
XEVPRM is based on
XML files. Basically
your software will gather together all your product licence information and any
related data about organisations etc, put it into XML format, and create a ZIP
file from it, along with any documents that are also required. You will then
send this file to the EMA. EMA will process this file per their rules and
review and update their database with your valid information and generate EV
codes for the new records. Then it will create an acknowledgement file that
will say which data it found to be valid and which is invalid. Finally it sends
the file back to you. Your software will then read this file and use it to
update your database with the EV Codes that it has allocated to your data.
IDMP will also
require software implementation but it is far more comprehensive than XEVPRM. Comparative
analysis of IDMP requirements Vs. XEVMPD given below shows IDMP is a far more broad
set of standards vs. XEVMPD.
|
XEVMPD
|
IDMP
|
IDMP data Source
|
|
Medicinal
product
|
Medicinal product
|
Regulatory
Knowledge, RIM System
|
|
Regulated
document
|
Regulated document
Version
|
Regulatory
Knowledge, RIM, ERP Systems
|
|
Medicinal
Product name
|
Medicinal Product name
Country/language
|
Regulatory
Knowledge, RIM System
|
|
Medicinal
product classification
|
Medicinal product classification
Manufacturer/Establishment
Marketing authorization holder
Manufacturing operation
Medicine regulatory agency
|
Regulatory
Knowledge, RIM System
|
|
Marketing
authorization
Marketing
authorization procedure
Marketing
authorization application
|
Marketing authorization
Marketing authorization procedure
Marketing authorization application
Marketing status
PSUR
|
Regulatory
Knowledge, RIM System
|
|
Packaged
medicinal product
Device
|
Packaged medicinal product
Device
Device batch identification
Batch identifier
Shelf life/storage
Device nomenclature
Package Container
Package component
Manufactured item
Other characteristic
Physical characteristics
Device batch identification
|
Labeling/ERP
Systems
|
|
Pharmaceutical
product
Route
of administration
|
Pharmaceutical product
Route of administration
Pharmaceutical product characteristics
PHPID set
|
Regulatory
Knowledge, RIM System
|
|
Specified
substance
Reference
strength
Ingredients
Strength
Substance
|
Specified substance
Reference strength
Ingredients
Strength
Substance
|
CTD
Module 3, Quality Systems
|
|
Clinical
particulars
Therapeutic
indication
|
Clinical particulars
Therapeutic indication
Undesirable effects
Contraindication
Interaction
Interactant
Population specifics
Other therapy Specifics
|
Regulatory
Knowledge, Labeling, Pharmacovigilance, Clinical
|
|
New requirement
Scope expanded
Same
|
||
Reference to above
table, 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. To comply with the IDMP
standards; companies will need to do data assessment, Preparation to meet the
gaps, software selection and implementation of the system.
The EMA expects to have draft guidance in June 2015.
