PSUR as an example of standardisation and harmonisation

Written by: Fleming. Team

1. What are the most significant changes in the latest updates on PSUR regulatory demands?

The most significant change is the mandatory use of the PSUR Repository for all PSUR submissions as of 13 June 2016. Another important change is the establishment of an Advisory Group for the EU reference date list (GPAG), which allows harmonisation of DLP for different products.

Many initiatives were done in 2016, for example, the PRAC/CMDh workshop in January 2016 for common understanding of optimal use of the single assessment for old substances, finalisation of the PRAC/CMDh working document on common understanding of PSUR assessment in May 2016 and a first draft for public consultation of Explanatory Note to GVP Module VII.

The next steps to expect in 2017 would be Joint assessors’ & industry training and revision of GVP Module VII on PSUR.

2. What are the challenges connected to changes to the submission of PSURs and how to use the PSUR repository correctly?

This new process was implemented very smoothly. There were no big challenges in the submission process. Good training, excellent webinars and training materials contributed to the successful implementation of the new process.

One of the challenges that I would like to mention is availability of information at different places that MAH have to monitor. For example, EMA will publish information on the outcome of PSURs in the PRAC minutes and on the EPAR page for CAPs; the EC Decision on the PSURs will also be published in the Community Register and the outcome of PSURs for NAPs only as well as for mixed CAPs/NAPs will be published on the EMA website. Final assessement reports are published on EMA websites that is not easy to search.

Update of product information and RMP based on PSUR evaluation is another challenge. This could be avoided if the distribution of Final AR is done to all MAHs in the EU that need to implement the outcomes.

3. What are the most common mistakes we should avoid regarding PSUR submissions?

Some MAHs experience a problem in submission if the product was not registered in the article 57 database or if the product was registered in less than 24 hours. In this case, submission will not be possible. To avoid this, you have to register your product, wait for 24 hours and then submit.

Another challenge is situations for MRP/DCP products where EURD list entry is not yet established and legally binding – submission via EU Single assessment mode not possible. In such cases, the Non-EU single assessment mode of the PSUR Repository has to be used.

I also would like to mention that there were many discussions for generic companies when there were changes in the EURD list from “submission required” to “submission not required”. Changes of the EURD list became effective six months later and there was confusion if a generic company would have to submit PSUR or not.

Find out more about PSUR regulatory demands at the

Europe Pharma

Pharmacovigilance & Risk Management Strategies

Visit event website