EMEA to fully implement Product Information Management

October 2, 2009
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Pharmaceutical Technology Europe PTE

The EMEA intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into the centralized procedure within 2 years, according to a statement of intent from the agency.

The EMEA intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into the centralized procedure within 2 years, according to a statement of intent from the agency.

PIM implementation is in a pilot phase where PIM submissions are only accepted subject to prior discussion with the EMEA. The agency's statement, however, has outlined four main milestones that will lead to full implementation of PIM.

  • Q2 2009. The EMEA began migration analysis and planning, with proof-of-concept migration exercises to be conducted towards the end of 2009.
  • Q1 2010. All centrally authorized product information will begin to migrate to the PMI format.
  • Q3 2010. The formal pilot phase will end. The PIM approach will be strongly recommended for all new marketing authorization applications and post-authorization activities for products that have already migrated.
  • End of Q4 2011. All centrally authorized product information should be in PIM format. The EMEA will strongly recommend the PIM approach for all new marketing authorization applications and post authorization activities.

PIM was first introduced by the EMEA in December 2005 to help improve the management and exchange of product information, as well as its quality and consistency. According to a Q&A published on the agency's website, the PIM approach will "allow better interoperability with other regulatory agency information systems". It will also "facilitate provision of product information to the public and healthcare professionals as the data will be of higher quality, and files easier to navigate".

Ultimately, the agency believes that PIM will lead to better quality information.

www.emea.europa.eu