In December 2015, we published a pharmacovigilance article “Periodic Safety Update Single Assessment (PSUSA) – An Overview” which outlined the process the European Medicines Agency(EMA) take to monitor the safety of medicines in Europe. Periodic safety update reports (PSURs) are pharmacovigilance documents submitted by marketing authorisation holders (MAHs) at defined time points during the post-authorization phase of their medicinal products. PSURs provide a comprehensive and critical analysis of the risk-benefit balance of a medicinal product taking into account new or emerging safety information.
The EMA currently maintains a list known as the “EURD list” which governs the active substances/combinations of active substances and EU reference dates for which PSURs are to be submitted. The EURD list also defines the type of submission procedure for a PSUR single assessment (PSUSA). For nationally authorised products (NAPs), the PSUR submission is made to the relevant National Competent Authorities of the registered member states, the lead member state appointed and the EMA. While for centrally authorised products (CAPs), PSURs are submitted to the EMA only via a central PSUR repository.
In order to determine the type of procedure (CAPs, CAP/NAP, NAPs only), submission dates, PSUSA procedure number and requirements for submission of products referred to in articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended, please refer to the EURD list.
However, from 13 June 2016 this central PSUR repository will become mandatory for all PSUR submissions for both NAPs and CAPs. From this date onwards, the MAHs will be required to submit PSURs to the EMA via the PSUR Repository only and there will no longer be any requirement to submit PSURs to National Competent Authorities. As always, MAHs are required to submit PSURs once a medicinal product is authorised in the EU, regardless of its marketing status.
A new version of the PSUR Repository which went live in January can be accessed using the eSubmission Gateway/Web Client. Further information can be found here: http://esubmission.ema.europa.eu/psur/psur_repository.html.
It is now mandatory to include an XML delivery file within the PSUR submission package (i.e. in the relevant ZIP file). The delivery files can be created here: https://psur-repo.ema.europa.eu/psur-ui/prepare/submission.html
Please note that the delivery file name cannot be changed and must remain as originally created i.e. delivery.xml. The mandatory use of the PSUR XML delivery file is introduced to harmonise the submission mechanism for all PSURs and it applies to all types of PSUR and PSUR supplementary information submissions.
In conclusion, for medicinal products registered through CAPs, PSUR submissions to the PSUR Repository are already mandatory. From 13 June 2016, this will also apply to NAPs. In the meantime, PSUR submissions for NAPs are made through both the PSUR Repository and relevant National Competent Authorities in which the medicinal product is registered. The PSUR must be submitted as per CTD style electronic formats i.e. eCTD or NeeS and validated using an appropriate validator. PSURs submitted that are not in CTD format or validated cannot be uploaded into the PSUR Repository.
If you have questions about PSUR submissions or need support with your in-licencing requirements, call or email us here at Acorn Regulatory.
We’ll be glad to help!