The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs by medicines regulatory authorities in the EU.
Periodically, pharmaceutical companies are required to evaluate the benefits and risks of authorised medicines and to summarize the results in a PSUR submitted to EMA. The Agency uses this information to determine whether new risks are identified for a medicine or the balance of benefits and risks of a medicine has changed and take appropriate action. For medicines containing the same active substances or combinations of active substances, the Agency assesses the related PSURs together even if the specific substances are contained in different medicines and authorised in more than one Member State.
The new central repository stores PSURs, PSUR assessment reports, comments, and final outcomes, and gives secure access to authorised users from national competent authorities (NCAs) in EU Member States, EMA, Agency committees, and the European Commission. It will ensure that all people involved in benefit risk assessments of medicines have timely access to all relevant documents in one location.
The repository also facilitates the electronic submission of PSURs by pharmaceutical industry. While PSURS are transmitted via the existing eSubmission Gateway/Web Client, which are the Agency’s secure electronic submission channels for documents supporting applications for human medicines, companies can now complete an XML delivery file attached to the submission and no longer need to use manual file naming conventions.
Companies are encouraged to register for webinars on the PSUR Repository for pharmaceutical industry, which will be organised in February 2015 followed by weekly questions and answers sessions, and to regularly check the eSubmission website for updates on the phased implementation process. Further information on webinars and registration can be found on EMA website. Companies, who have not previously used eSubmission Gateway/Web Client, should register as soon as possible. More information on the eSubmission Gateway/Web Client can be found on the eSubmission Gateway/Web Client website.