The PSUR Work Sharing and Synchronisation Project was initiated in 2002 under the auspices of the HMA and the European Risk Management Strategy Facilitation Group (ERMS FG). The concept of the project was that substances would have harmonised birthdates allowing MAHs to submit PSURs for products containing the same substance to NCAs at the same time, thereby allowing work sharing and reducing administrative burden. To this purpose, the PSUR Work Sharing and Synchronisation list, containing the EU birth dates and synchronised DLP of substances, was compiled with input from the Pharmacovigilance Working Party (retired in July 2012) and representatives from the European Federation of Pharmaceutical Industries and Associations (EFPIA), Association of the European Self-Medication Industry (AESGP) and European Generic medicines Association (EGA). The list was maintained by the EMA since 2008 considering comments received from MAHs and NCAs. Moreover, the CMDh PSUR Work Sharing Working Group (PSUR WS WG) was established to facilitate the PSUR Work Sharing Project and became a Working Party of CMDh in 2012. In 2015, the group was renamed Pharmacovigilance Procedures Work Sharing Working Party and its mandate was widened; the mandate can be found at https://www.hma.eu/human-medicines/cmdh/cmd-working-parties-/-working-groups/working-party-on-pharmacovigilance-procedures-work-sharing.html.
