Periodic Safety Update Single Assessment (PSUSA) – An Overview

In this blog we look at the Periodic Safety Update Single Assessment  or PSUSA.

The World Health Organisation defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Due to limits of clinical trials, continuing to collect information on a medicine following authorisation is an important way to monitor the safety of medicines.

In Europe, one way regulatory authorities collect this important information is via Periodic Safety Update Reports (PSURs). These documents are intended to provide a thorough analysis of the risk-benefit balance of a medicine taking into account new or emerging safety information.

The European Medicines Agency (EMA) currently maintains a list known as the “EURD list”, the principles of which are included in the GVP Module VII. This consists of a list of active substances and combinations of active substances for which PSURs are to be submitted in accordance with the EU reference dates (the first or earliest known date of the marketing authorisation in the EU) according to defined frequencies. The list aims to harmonise the frequency of PSUR submissions thus allowing the single assessment of related PSURs to take place.

The EURD list also defines the type of procedure for a PSUR single assessment i.e. if it involves nationally authorised products (NAP), centrally authorised products (CAP) or a mix of both. This is important when it comes to submitting the PSUR, as currently the different procedure types have different submission requirements. For example for a PSUSA procedure involving NAPs only, submission is made to all member states, the lead member state appointed and the EMA. However the good news is that from June 2016, PSURs will be submitted to the EMA only via a central PSUR repository and submission to national competent authorities will no longer be required.

Once the PSUR has been submitted, the MAH can expect to receive the assessment outcome according to following timetable;

Start of procedure: Day 0

PRAC Rapporteurs preliminary assessment report by: Day 60

PRAC and MAH comments on the Rapporteur preliminary assessment report by: Day 90

PRAC Rapporteur’s updated assessment report (where applicable) by: Day 105

PRAC recommendation: Day 120

So what are the possible outcomes of the single assessment? The outcome may be maintenance of the current licence or a variation may be required. Where PRAC recommends any regulatory action, the recommendation will be sent to the CHMP/ CMDh. In this case the CHMP opinion / CMDh position is available by Day 134.

The EMA publishes a list of outcomes for NAPs on their website while outcomes for CAPs are published as part of each medicine’s European public assessment report (EPAR). Any changes to the product information as a result of the PSUR assessment are implemented without subsequent variation for CAPs and through the appropriate variation at national level for NAPs.

If you would like to discuss issue further with us, then please call us on 00353 52 61 76706 or complete your details below.