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Regulatory News | 23 February 2015 | By Michael Mezher
The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs.
The goal of the task force will be to develop a roadmap for EU-wide implementation of identification of medicinal products (IDMP) standards developed by the International Organization for Standardization (ISO).
EMA recently issued an explanatory document titled Data submission of authorised medicines in the European Union. The document outlined the data submission requirements for medicinal products under Article 57 of Regulation (EC) No. 726/2004, and provided information to companies on the scope and format of the data to be submitted.
For more information about data submission requirements under see our article “EMA Explains Centralized Product Database, Talks Future Changes”
In the document, EMA says that it is looking to replace its current eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) with IDMP standards. The move is also made to comply with Articles 25 and 26 of Commission Implementing Regulation (EU) No. 520/2012 which “require the use of common standards, formats and terminologies for the identification and exchange of information on medicines.”
Regulation (EU) No. 520/2012 specifically states that member states, EMA and marketing authorization holders must apply terminology from the following ISO standards: 11615:2012, 11616:2012, 11238:2012, 11239:2012 and 11240:2012.
EMA is calling for interested parties to apply to participate in the EU ISO IDMP Task Force. The task force will be made up of representatives from EMA, national competent authorities and pharmaceutical industry association members. The agency is also looking for task force members who develop medicinal product dictionaries and databases, as well as other parties with expertise in the field.
The task force will be responsible for developing a roadmap that will include “a gap analysis comparing XEVMPD and ISO IDMP” and a plan to migrate data from XEVMPD to ISO IDMP.
Interested parties can submit expressions of interest to the agency by 6 March 2015.
By moving to IDMP standards, EMA hopes it will be easier for regulators to exchange information and facilitate healthcare authorities’ efforts to develop electronic health records. In addition, the agency says common, internationally accepted standards for drug identification will improve the assessment of pharmacovigilance data.
EMA plans to transition to using IDMP standards in July 2016.
EMA Call for Expression of Interest
Tags: ISO, IDMP, XEVMPD