How to prepare your PSURs/ PBRERs
Today we are continuing our series on PSURs and PBRERs by focusing on how to prepare your Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Evaluation Reports (PBRERs) for medicinal products.
Don’t miss the important tip for today at the end of this blog…
How many PSURs/ PBRERs should I prepare?
You should submit one PSUR/ PBRER covering your medicinal products with the same active substance or combination of active substances according to the European Union reference dates (EURD) list. This should include all:
- authorised indications
- routes of administration
- dosage forms and dosing regimens
This applies even if the products have different names.
What about different products with the same active?
You should only submit separate PSURs/ PBRERs for different products with the same active substance if this was agreed when your MA was granted e.g. when there are different formulations of the active substance with significantly different indications.
You should follow the ICH guidelines and the Good pharmacovigilance practices (GVP VII) to prepare your document.
What are Data Lock Points (DLPs)?
Your ‘Data Lock Point’, which is what your specific submission date is based on, is the cut off point for preparing your report i.e. the end of the cycle.
What if my date is not on the EURD list?
If your submission date is not on the EURD list, it will be:
- 70 days after your DLP if your PSUR covers a period of 12 months or less
- 90 days after your DLP if your PSUR covers a period of 12 months or more
What should comprise my risk-benefit evaluations?
Your PSUR/ PBRER should:
- critically examine information received since your last PSUR to see if there are new signals that have led to potential or current risks or update information on previous risks
- summarise any new information on the safety, efficacy and effectiveness of the product that could affect its risk-benefit balance
- provide an integrated benefit-risk analysis from the date of an interventional clinical trial (in any country) for all authorised indications – if you don’t know the date or you can’t access the information use the earliest applicable date for clinical developments as a starting point
- summarise any risk minimisation actions implemented or planned during the reporting interval
- outline plans for signal or risk evaluations including timelines and/or proposals for additional pharmacovigilance activities
- also include the results of any new studies carried out on the safety of your product around off-label use, with a summary of their impact.
What sources can I use to help demonstrate the efficacy, effectiveness and safety information of the product in my risk-benefit evaluation?
Sources might include:
- non-clinical studies
- spontaneous reports (e.g. reports on the marketing authorisation holder’s safety database)
- active surveillance systems (e.g. sentinel sites)
- investigations of product quality
- product usage data and drug utilisation information
- clinical trials, including research in unauthorised indications or populations
- observational studies, including registries
- patient support programs
- systematic reviews and meta-analysis
- marketing authorisation holders’ sponsored websites
- published scientific literature or reports from abstracts, including information presented at scientific meetings
- unpublished manuscripts
- licensing partners, other sponsors or academic institutions and research networks
- competent authorities (worldwide)
Other sources outside of those above can also be included to demonstrate the risks and benefits of the medicinal product.
Are there any exemptions?
You need not submit routine PSURs/ PBRERs if your medicinal product falls under some articles in the European Commission’s directive (2001/83/EC), unless there’s a specific condition in your MA or it’s indicated in the EURD list. These are:
- article 10.1 generic (previously article 10.1 a ii)
- article 10.a – well established use (previously article 4.8ii)
- article 14 – homeopathic medicine
- article 16a – traditional herbal medicine
See the European Commission’s directive (2001/83/EC) for more information.
You may be able to use some of the same modules in the development safety update report (DSUR) and or risk management plan in the PSUR/ PBRER to minimise duplication and improve efficiency. See appendix D in the ICH guidelines for more information.
Other blogs in this series include:
- An introduction to PSURs and PBRERs
- How are PSURs processed in the EU?
- How are PSURs processed in the UK?
Do you have any questions/ comments or need support in this area? If so then please get in touch with us here at Fusion Pharma – we love hearing from you:
firstname.lastname@example.org or Tel: +44 (0) 203 1379 799