EMA calls for industry involvement in applying new ISO standards to drugs

By Gareth Macdonald contact

- Last updated on GMT

Europe
Europe

Related tags: Pharmacology, European union

The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.

The European Medicines Agency (EMA) called for expressions of interest​ last Friday, asking drug firmsinterested in taking part - as well as industry groups and national regulators - to apply before March 6.

The new standards – called the identification of medicinal products (IDMP) – were finalised by the International Organization for Standardization​ (ISO) in 2012. They include identification numbers for drugs as well as information on ingredients, dosage forms and administration routes.

According to the EMA “The 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​.”

The agency added that the taskforce will develop implementation guidelines for the standards, with the aim being to complete the project this year ahead of roll out early in 2016.

Pharmacovigilance

Under pharmacovigilance rules introduced in 2012​, drugs sold in the European Union must be identified using common standards, specifically the ISO IDMP standards, to facilitate more straightforward information exchange.

The EMA’s decision to seek industry involvement in the IDMP roll-out follows a year after its plan to charge drugmakers fees for drug safety assessments – also part of the 2012 pharmacovigilance rules – met with a hostile response​.

In addition, while the new taskforce will focus on how the IDMP can be best applied to facilitate data exchange in the EU, its work will have an impact on the agency's interaction with other regulators.

In 2014, the EMA and the US Food and Drug Administration (FDA) started holding monthly teleconferences to discuss drug information and safety issues.

These discussions involved exchange of information of pharmacovigilance. 

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