EMA Green Lights New Central Safety Report Repository

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-15-2015 13:12


The European Medicines Agency (EMA) Management Board gave its green light for the central repository for periodic safety update reports (PSURs) for medicines authorized in the European Union (EU). In one year’s time, on June 13, 2016, the central repository will become the single, central platform for these reports to be used by all regulatory authorities and pharmaceutical companies in the EU to exchange information on the safety of medicines.

The decision of the Management Board follows an independent audit of the repository that evaluated whether it meets the agreed functional specifications. On the basis of the audit outcome, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the use of the new electronic repository for the whole of the EU.The central repository for safety reports is a new tool introduced by the EU pharmacovigilance legislation that is intended to facilitate the exchange of information on the safety of authorized medicines between national competent authorities (NCAs) and the pharmaceutical companies in safety monitoring for authorized medicines across the EU. It has been delivered under the EU Telematics Strategy 2014-2016.

The EMA said that the centralized PSUR repository provides an important simplification for the industry allowing marketing authorization holders to upload the PSURs to one location. It also facilitates the assessment process by ensuring NCAs in each member state, EMA and its scientific committees, and the European Commission have timely and secure access to all relevant documents.

PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. Marketing authorization holders must submit PSURs at defined time points following a medicine’s authorization. PSURs summarize data on the benefits and risks of a medicine and include the results of all studies carried out with this medicine, both in its authorized uses and in unauthorized uses.

The agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed. It can then decide if further investigations need to be carried out or can take action to protect the public from the risks identified, such as updating the information provided for healthcare professionals and patients.

Pharmaceutical companies now transmit their PSUR-related information to EMA via the eSubmission Gateway/Web ClientExternal link icon website, the agency’s secure electronic submission channels for documents supporting applications for human medicines.

As of September 1, 2015, companies should use the XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website. After this date, it will no longer be possible to submit PSUR submissions using the existing file-naming convention. The PSUR XML delivery file for EMA submission is introduced to harmonize the submission mechanism for all PSURs submitted to EMA and it will apply to all types of PSUR and PSUR supplementary information submissions. Further information can be accessed via the statement of intent for use of xml delivery file. External link iconPharmaceutical companies, who have not done so already, are encouraged to register to use the submission tools as soon as possible. This can be done via the eSubmission Gateway/Web Client website, where interactive training sessions and tools are also available.

Source: EMA


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