PSUR Work Sharing and Synchronisation Project
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 is 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. The EU PSUR Work sharing Working Group (WS WG) was established to facilitate the PSUR work sharing project and became a Working Party of CMDh in 2012. In 2015 the working party was renamed to the Pharmacovigilance Procedures Worksharing Working Party; its mandate can be found at (http://www.hma.eu/330.html).
Directive 2010/84/EC establishes the legal requirements for submission of PSURs and introduces the principle of EU single assessment with a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC) for substances authorised in more than one Member State. A step-wise approach has been taken to the full implementation of new PSUR procedures introduced by the pharmacovigilance legislation and the EMA Management Board decided that the implementation of single assessment for substances only included in NAPs will not start in 2013 and that the work sharing project would continue in its current framework until the single assessment procedure is introduced for NAPs. It was subsequently decided that the single assessment procedure would be introduced for procedures that have data lock points (DLP) after 31st August 2014.
PSUR Work Sharing and Nationally Authorised Products with a DLP Synchronised
The Periodic Safety Update Report Work Sharing (PSUR WS) and Synchronisation lists were 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). They have been maintained by the European Medicines Agency (EMA) since 2008 taking into account comments received from Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs).
The PSUR Work Sharing list was updated, merged with some substances from the synchronisation list and renamed 'List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised' in order to accommodate the outcome of the December 2012 EMA Management Board meeting not to start the EU single assessment until further notice of PSURs for active substances and combinations of active substances contained only in nationally authorised medicinal products (NAPs).
Such active substances and combinations of active substances originally included in the List of Union reference dates and frequency of submission of Periodic Safety Update Reports (also called EURD list and defined as the tool to allow for the EU single assessment of PSURs in Article 107c paragraphs (4) and (7) of Directive 2001/83/EC as amended) with Data Lock Points (DLPs) between 1 April 2013 and 31 August 2014, were removed from the EURD list and transferred to the new PSUR WS list until they follow the EU single assessment procedure of PSURs.
MAHs are strongly advised to submit their PSURs in accordance with the List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised which should be legally interpreted as a "coordinated" national request addressed to MAHs in accordance with Article 107c (2) of Directive 2001/83/EC as amended.
- List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised-Excel [PDF version] (February 2015)
For more details on the legal basis, the consequences for removing the substances concerned from the EURD list and on the changes made to the new PSUR WS list please refer to the document Assessment of Periodic Safety Update Reports for Nationally Authorised Products.
- Assessment of Periodic Safety Update Reports for National Authorised Products Cover note (June 2014)
Update: The Agency intends to start the single assessment of active substances contained only in nationally authorised medicines by the end of 2014.
The "List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised" should continue to be followed until the substances and combination of active substances included have passed the published data lock point (DLP). Subsequently, the EURD list should be followed.
Any comments or questions should be addressed to the following mailbox: P-PV-Helpdesk@ema.europa.eu.
PSUR Work Sharing - Other guidance documents
- CMDh Best Practice Guide for Transitional Arrangements for PSUR Work Sharing (January 2015) [Track version]
Annex 1 - Assessment report template (April 2014)
Annex 2 - Email templates
Annex 3 - Template for sending comments to P-RMS
Questions and answers