EMA Plans Task Force for ISO Standards


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-23-2015 14:53

  

The European Medicines Agency (EMA) is establishing a task force for the implementation of international standards for the identification of medicinal products (IDMP) for human use in the European Union (EU). The agency is inviting interested parties to express their interest in being part of the task force.

The IDMP standards developed by International Organization for Standardization (ISO) establish data elements, formats, and terminologies for the unique identification of medicines and the exchange of information on medicines, including pharmaceutical dose forms, routes of administration, packaging, and active substances. These standards are expected to simplify the exchange of information between regulatory authorities across the world and to support healthcare authorities in the development of electronic health records. They should also improve the safety monitoring of medicines by facilitating the assessment of data across classes of medicines and therapeutic areas.

The standards were finalised in 2012. The implementation guides are currently under development at international level and expected to be available in 2016. The European pharmacovigilance legislation requires the use of common standards in the EU to identify and exchange information on medicines, and makes specific reference to the ISO IDMP standards.

With the establishment of an ISO IDMP task force, EMA and the European medicines regulatory network intend to open a dialogue with all interested parties to discuss the implementation of the ISO IDMP standards in Europe. The task force will agree an EU strategy and develop a road map and an EU implementation guide as key deliverables for 2015. The task force will include representatives from the EMA, national competent authorities in EU Member States, pharmaceutical industry represeneatives as nominated by the EU pharmaceutical industry associations, software vendors, service providers and developers of medicinal product dictionaries or databases, and other interested parties such as organisations with expertise in terminologies supporting the electronic exchange of information on medicines and substances. Interested parties need to submit their expressions of interest to the EMA by March 6, 2015.

Source: EMA

0 comments
30 views


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription 

Permalink