Bringing a medicine to Europe requires navigating several key regulatory milestones before submission. The European Union (EU) pharmaceutical regulatory landscape is undergoing significant reform, with proposed legislation set to reshape how medicines are developed, assessed, and approved.
We hosted a webinar outlining the key EU pre-approval regulatory deliverables required to support successful marketing authorisation and discussed how the upcoming EU pharmaceutical legislation will impact regulatory planning and medicine development.
Webinar topics included the following regulatory deliverables:
- Scientific Advice procedures
- Orphan Drug Designation and maintenance
- Paediatric Investigation Plans (PIPs)
- Expedited EU pathways (PRIME)
- Marketing Authorisation Application preparation
Here is a snippet of some of the topics we covered in the webinar…
Orphan-designated medicines
The proposed pharmaceutical legislation introduces important changes for orphan-designated medicines. While the current prevalence threshold for orphan designation remains unchanged, the legislation places greater emphasis on products addressing high unmet medical need.
This may affect eligibility criteria and market exclusivity incentives, with revised protection periods depending on product type and unmet need status.
Priority Medicines (PRIME) scheme
The PRIME scheme supports medicines targeting unmet medical needs through early regulatory interaction and accelerated assessment opportunities. The reforms propose enhanced support for innovative therapies, orphan medicines, and priority antimicrobials addressing antimicrobial resistance.
Paediatric medicine development
Paediatric medicine development will continue to require an agreed PIP or waiver before submitting an MAA. Procedural changes are proposed, including shifting responsibility for PIP review under the Committee for Medicinal Products for Human Use (CHMP) and providing free scientific advice on paediatric study design.
The Marketing Authorisation Application (MAA)
The pharmaceutical legislation also aims to streamline the MAA process through consolidated EMA committees, a simplified centralised procedure, and reduced evaluation timelines for new medicines.
Regulatory data and market protection
The regulatory data and market protection framework will become more conditional, with extension opportunities linked to unmet medical need, EU-wide launches, and additional indications.
Watch the webinar recording
To learn more about the evolving EU regulatory landscape and the practical implications for your development strategy, download the webinar to explore the key pre-approval regulatory deliverables and upcoming pharmaceutical legislative changes in more detail.
Watch Now
Sign up to our monthly newsletter to watch this webinar now. Our newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.