Periodic Safety Update Single Assessment (PSUSA) – An Overview

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

What Is Pharmacovigilance?

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.

PSUR’s

In Europe, one method that regulatory authorities use to 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 medicine taking into account new or emerging safety information.

The EURD List

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.

PSUR Timetable

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 the 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.

Need PSUR Assistance?

Our pharmacovigilance team works with clients on all PV issues, including those related to PSUR’s.  We can assist you with any issues that you might have. If you would like to discuss the issue further with us, then please call us on 00353 52 61 76706 or complete your details below. [ninja_form id=1]

Further Reading from Acorn Regulatory

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients. Read more here.

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about it here.  5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated. Read the full article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team. Download the e-book here.

A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail. Read more here.