16 Oct 25
Welcome to tranScrip’s monthly newsletter where we share with you the latest news and views from across the organisation. This edition includes:
A message from our Head of Regulatory
Dear Readers,
I’m delighted to welcome you to the June edition of tranScrip’s newsletter.
This month, our spotlight turned to the evolving regulatory landscape in Europe, with insights drawn from our latest webinar, “Optimising EU Success With Smart Regulatory Strategy”. The session explored the importance of early integration of EU regulatory plans into global development strategies, highlighted key EU requirements for paediatric development, provided practical guidance for navigating the Clinical Trials Information System (CTIS), and examined medical writing and data transparency expectations in the EU.
We also delved into the EU’s Health Technology Assessment (HTA) Regulation. With Joint Clinical Assessments (JCAs) mandatory for oncology and advanced therapeutic medicinal products (ATMPs) since January 2025, and soon to include orphan drugs and all centrally authorised products, biotech companies must proactively prepare for JCA submissions. Our article outlined what you need to know and do to stay ahead.
From paediatric strategies to disclosure and redaction planning in medical writing, one thing is clear: success in today’s EU regulatory environment demands foresight, expertise, and collaboration. tranScrip’s team of specialists stand ready to partner with you to develop smart regulatory strategies that will expedite your path to market and help bring effective medicines to patients quickly.
Thank you for staying connected with us.
Warm regards,
Roz Sutton
SVP, Head of Regulatory
tranScrip
Optimising EU Success With Smart Regulatory Strategy
In our latest webinar, tranScrip experts explored the critical elements of building a globally effective regulatory strategy, with a sharp focus on the evolving European landscape.
Here are the top insights:
Early planning, communication and engaging with experts is essential – tranScrip is at the ready to partner with your teams and guide you through the complexity > contact us
Missed the session? Keep your eye on our LinkedIn page for the recording!
EU HTA Regulation: Are you Ready for JCA?
With the EU HTA Regulation coming into effect from January 2025, there is growing interest and discussion around the exact expectations for EU JCA. For new medicines that fall under the scope of the regulation, a JCA submission will be required. The JCA submission, that details clinical data related to market access considerations, will undergo an EU-wide assessment that will run in parallel with EMA’s regulatory review.
JCAs are now mandatory for oncology and ATMPs and the scope will expand over the coming years to include orphan drugs and all centrally authorised products.
What does this mean for biotech?
– One EU-wide assessment of clinical data related to market access
– Earlier planning to generate the data needed for a JCA submission will be critical
Read our latest article to find out what you need to do now to stay ahead:
EU HTA Regulation: Are you Ready for Joint Clinical Assessment?
Upcoming Conferences and Events
Christopher Floyd will be joining an exciting line up of panellists at One Nucleus’ ON Helix this year.
As part of the session “Getting Ready for Clinic”, Chris will be contributing his deep expertise in early drug development to a discussion that tackles the challenges of pre-clinical research and the strategic decisions that pave the way for clinical success.
If you’re also attending, get in touch, it would be great to connect.
Thank you for reading this month’s edition of tranScrip’s newsletter. Feel free to share your feedback in the comments.
To learn more about how we can support you, contact us.
Best regards, The tranScrip Team
Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.