Hello, fellow healthcare enthusiasts and pharmaceutical professionals! The European Medicines Agency (EMA) has just dropped a new set of answers in their post-authorisation procedural advice! If you're not already in the know, this is the guidance document (EMEA-H-19984/03 Rev. 105) that provides crucial advice for users of the centralised procedure. Let's delve into the exciting answers and updates that were rolled out in October 2023.
Understanding the Centralised Procedure of Marketing Authorization in Europe:
But before we jump into the new insights, let's refresh our memory about what the centralized procedure is all about. In the European Union (EU), there are various pathways for getting new medicinal products to the market. The centralised procedure is a streamlined approach reserved for medicines with significant public health benefits. It offers a single marketing authorization that's valid across all EU member states, ensuring efficient access to vital medications for all.
The October 2023 Update - What's New?
So, what's fresh in this latest update? Let's take a closer look:
- Co-Rapporteur's Role in Type II Variations
Wondering about the involvement of the Co-Rapporteur in Type II Variations? Well, the Co-Rapporteur typically doesn't participate in the assessment of Type II Variation applications, which include quality, non-clinical, clinical changes, and RMP updates. However, their involvement is often deemed necessary for new therapeutic indications or modifications of approved indications.
- Non-Interventional Imposed PASS
The rules governing non-interventional imposed PASS are set in Articles 107n-q of Directive 2001/83/EC.
- EU PAS Register - Speedy Updates for Transparency
Marketing Authorization Holders (MAHs) should register study protocols and public abstracts of results of non-interventional imposed PASS (Post-Authorisation Safety Study) in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register) as soon as they're finalized. It's all about fostering transparency in non-interventional PASS and supporting the exchange of pharmacovigilance information between the EMA, NCAs (National Competent Authorities) and MAHs.
- RMP Summary Publication
The EMA is taking transparency up a notch by publishing the full Risk Management Plan (body and annex 4 & 6) for all post-authorisation RMP updates assessed and approved in procedures concluding on or after 20 October 2023.
The redacted RMP PDF will be published on the EMA website at the time of the EPAR update, on the product’s page (EPAR summary landing page).
- Article 46 Pediatric Study Submission
The EMA's update reaffirms the obligation for Marketing Authorization Holders to submit MAH-sponsored pediatric studies, whether or not they are part of a Paediatric Investigation Plan (PIP). This includes studies regardless of their status, publication, or where they were performed. It's all about ensuring comprehensive data availability.
- Requesting Central Marketing Authorization Withdrawal
The process of requesting the withdrawal of central marketing authorization has been clarified.
Provided that the withdrawal is solely based on commercial reasons (i.e. the withdrawal of the marketing authorisation is not linked to underlying quality, safety, efficacy or benefit/risk issues), it is agreed at EU level that there is no need for batch recalls, the medicinal product can remain on the EU market until expiry date. The MAH remains responsible for the batches on the market and for pharmacovigilance activities.
In Conclusion
The October 2023 updates in the EMA's post-authorisation procedural advice are not just pieces of paper; they are blueprints for a healthier, safer, and more transparent future for all of us. Whether you're shaping the future of medicine, overseeing their quality, or relying on it for your health, these updates are key to navigating the pharmaceutical world's ever-changing landscape.
Stay tuned for more developments and keep an eye on the EMA's guidance documents – they're your compass in a rapidly evolving healthcare environment.
And if you're seeking expert support in pharmacovigilance and regulatory affairs services, don't hesitate to reach out. We're here to guide you through these changes and help you make the most of them.
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