From 13 June, 2016 onwards
In a recent update, it has come to light that the companies in the UK will no longer be submitting the Periodic Safety Update Reports (PSURs) to the national regulators including the Medicinal and Healthcare products Regulatory Agency (MHRA). Alternatively, the submissions will be directed towards the central repository at the European Medical Agency (EMA), which is going to be mandatory from 13 June 2016.
What is a PSUR?
A PSUR/PBRER (Periodic Benefit Risk Evaluation Report) is a periodic safety update which is being submitted to MHRA once a product is registered in the EU region irrespective of whether the product is marketed or not. The report contains all the information regarding active ingredients, components, combinations, formulation, dosage, indications etc. The main purpose of submitting this report is to provide safety information related to the approved drug and to include new limitations if any.
So far companies in the UK are habituated to submit the periodic safety reports to MHRA, once in every six months or once a year, based on product’s market presence. But from now on, even if the product is approved and authorized only in the United Kingdom, companies shall submit PSURs to central repository at EMA which was introduced in July 2012 for the storage of related assessment reports.
The PSUR submission to EMA repository is going to be mandatory from 13 June 2016, but till then companies should also follow current submission procedures to MHRA, as usual. As per updated MHRA guidance, companies can continue submitting the PSURs to MHRA with:
- a cover letter containing: a summary of submission being made, MA number, the product name and the reporting period outlined in the EURD list
- the filled up application form
- the PSUR/PBRER which is prepared as per ICH guidelines
Submissions & the XML Approach
The EMA has recently developed a user interface, availing which companies can generate XML delivery files that are to be included in the PSUR submission package. As referred in Annex 3, submissions in conjunction with required XML delivery file will no longer require the previous file naming conventions. There are no special requirements of ‘spaces’ or ‘underscores’.
Submitting the periodic safety reports is a critical process. Especially in short timeframes, it will be more challenging to source the information and to validate the safety and efficacy of the same. To navigate through these complexities, it is recommended to consult a global regulatory partner for mandate-driven services.