A year from now, drugmakers in the EU will be required to submit postmarket safety reports to an online central repository, the European Medicines Agency (EMA) has confirmed.
In January 2015, EMA announced the launch of a central repository, hosted on the eSubmissions website, for submitting periodic safety update reports (PSURs).
In the EU, drugmakers are required to submit PSURs to EMA at regular intervals. These reports are evaluated and used to ensure a product's safety after it is authorized by identifying new risks observed through a product's use.
According to EMA, the repository will be used to store both PSURs and corresponding PSUR assessment reports, comments and outcomes through a secure system that can be accessed by national competent authorities, EMA and its committees and the European Commission (EC).
The repository was developed as part of the EU Telematics Strategy, which was endorsed by the Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) Management Board in 2014 to improve the IT systems used in the regulation of medicines.
One of the strategy's objectives is to improve the technologies used to support pharmacovigilance in the EU, including:
- "An enhanced EudraVigilance system including capacity and tools for patient reporting, forwarding reports to Member States, extensive data access for industry and data provisions to [the World Health Organization];
- Literature monitoring by EMA on behalf of industry to enter cases into EudraVigilance;
- A repository for Periodic Safety Update Reports (PSURs) and their assessments including their collection, storage, retrieval and evaluation;
- The EU medicinal products web-portal linked to national web-portals;
- An auditable system for tracking drug safety signals (signal detection) and other pharmacovigilance issues;
- A database of medicinal products (Article 57 database)."
At its meeting this week, the EMA Management Board greenlit the repository to move forward following a positive evaluation by auditors from PricewaterhouseCoopers.
On 13 June 2016, drugmakers will be required to use the new repository for all PSUR-related activities. Additionally, beginning 1 September 2015, companies will be required to use an XML delivery file to submit PSURs to EMA, as opposed to older manual file-naming formats.
EMA Press Release, EMA Management Board Announcement