EMA experts awarded for excellence in standards development
Five EMA staff members – Paolo Alcini, Sabine Brosch, Tim Buxton, Ilaria Del Seppia and Panagiotis Telonis – have won an ISO Excellence Award for their achievements in the development of international standards for the identification of medicinal products (IDMP). The award was presented by Michael Glickman, chair of the International Organization for Standardization (ISO) Technical Committee for Health Informatics at the ISO plenary meeting on 22 October 2018 in Paestum, Italy.
These standards facilitate the exchange of information about medicines between regulators, worldwide data sources and pharmaceutical companies. They provide the basis for the unambiguous identification of medicines worldwide, which will strengthen regulatory activities and in particular improve the continuous monitoring of the medicines’ safety after they have entered the market.
“I congratulate my colleagues for their invaluable work and major contribution to global standardisation,” said Guido Rasi, EMA’s Executive Director. “Internationally accepted IDMP standards enable the efficient exchange of information on medicines and will improve pharmacovigilance and safety monitoring that we carry out to ensure patient safety.”
Research, development and production of medicines are global. However, regulatory requirements applying to medicines are fragmented as they are developed by various national regulators, resulting in different processes and operating models. This is further complicated by the use of multiple languages, different terminologies and data models, as well as different technical standards for information exchange.
EMA’s team was supported in their efforts by other EMA staff and experts from across the EU. They were part of a global collaborative effort led by ISO, involving medical experts from 32 participating and 27 observing countries who developed a set of five international IDMP standards. These standards provide common formats, data structures, quality criteria and terminologies to identify medicines and exchange information between worldwide regulators and healthcare communities. ISO IDMP covers the entire product lifecycle: medicines in development, medicines under evaluation and authorised products.
EMA is implementing the ISO IDMP standards in phases through its SPOR programme. With SPOR, EMA is delivering a set of master data management services for pharmaceutical and regulatory data relating to substances, products, organisations and referentials (SPOR) to enable consistent reuse in EMA’s multiple business cases.
Referential and organisation services were delivered and are already used in regulatory applications and business processes, such as electronic application forms (eAF), the orphan medicines application portal (IRIS) or the EudraVigilance (EV) user registration process. This is followed by the iterative implementation of products and substance data services.