ISO IDMP EMA official guidelines

ISO IDMP EMA official guidelines

The ISO IDMP standards establish
definitions and concepts, and describe data elements and their structural
relationships in order to build the unique identification of the medicinal
product.

Officially, ISO IDMP remains to
be implemented since July 2016, but due to delays in finalisation of the ISO
standards, it was agreed with the European Commission to implement ISO IDMP in
phases, as follows:

  • Iteration 1: Current Article 57 data and
    minimum required elements to assign and maintain identifiers for ISO IDMP
    (MPIDs, PCIDs and PhPIDs);
  • Iteration 2: ISO IDMP 11615 content to
    support the assignment and maintenance of the Investigational Medicinal Product
    IDs;
  • Iteration 3: Remaining EU requirements for
    the Clinical Particulars section;
  • Iteration 4: Batch Identifiers and remaining
    EU ISO 11615 and ISO TS 20443 compliant.

The Iteration 1 is expected to
be mandatory in 2019, and it covers the Article 57(2) Database from
Pharmacovigilance legislation.

The Article 57(2) of Regulation
(EU) 726/2004 states that for the purposes of the database, the Agency shall
set up and maintain a list of all medicinal products for human use authorised
in the European Union. Since 2012, the Marketing Authorisation Holders were
required to submit their data through XEVMPD database.

If XEVMPD contains currently
only Regulatory and Pharmacovigilance data, the ISO IDMP includes more detailed
information than XEVMPD ones, e.g.: Manufacturers, Investigational medicinal
products, Clinical particulars, Batch IDs.

Following this approach, the EMA
is looking for the implementation of SPOR data management system, which states
for Substance, Product, Organisation, and Reference, and which is considered as
a vehicle for implementing the ISO IDMP standards.

According to the last SPOR/IDMP
Task Force meeting, EMA is expected to run internal Organisation Management
System and Reference Management System in March 2017, and therefore external in
April 2017.

Asphalion is in direct contact
with EMA, and can give any support you need. If you need support please contact us at info@asphalion.com

More information on ISO IDMP can
be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp.

 

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