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EMA and national Scientific Advice
Navigating the regulatory pathways for pharmaceuticals and medical products in Europe requires careful strategic planning.
One of the most effective strategies to ensure success is seeking EMA/National scientific advice through all the drug development process, especially when aligning development plans with EU Health Technology Assessment (HTA) requirements.
At AzurBio Consulting, we specialize in guiding pharmaceutical sponsors through EMA and national Scientific Advice procedures, ensuring robust preparation and requirements fulfillment.
What is EMA and national Scientific Advice?
EMA Scientific Advice is an essential regulatory procedure provided by the European Medicines Agency (EMA), offering sponsors critical feedback on their quality, clinical, non-clinical, and methodological plans for medicinal product development. Early and continuous dialogue with the EMA via scientific advice can substantially streamline your drugs regulatory journey, minimizing uncertainties and reducing the risk of development setbacks.
National Scientific Advice is proposed by national competent authority (NCA). Each of them has their own requirements, processes and timelines and can cover all scientific and regulatory aspects. National advice can be critical depending on the regulatory route selected for registration or as a preliminary discussion before EMA Scientific Advice.
Why Regulatory Agencies Scientific Advice Matters for EU HTA
In the evolving landscape of European health policy, the interplay between regulatory approval (EMA/NCAs) and market access evaluations (HTA bodies) is increasingly integrated. With the introduction of the EU-wide Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), alignment of regulatory and HTA requirements has become crucial.
EMA/National Scientific Advice now frequently involves parallel consultations with HTA bodies, facilitating a harmonized approach toward evidence generation. This harmonization ensures that clinical studies not only satisfy regulatory criteria but also meet the expectations of HTA bodies responsible for reimbursement decisions across EU Member States.
Key Benefits of Seeking EMA/National Scientific Advice Early
1. Enhanced Predictability
By engaging EMA/NCAs early in the product development phase, sponsors can clarify regulatory expectations, streamline trial designs, and avoid unnecessary studies, significantly enhancing predictability and efficiency.
2. Alignment with HTA Requirements
EMA/National Scientific Advice sessions can be coordinated with HTA bodies, providing invaluable insights into clinical endpoint selection, comparator choice, patient-reported outcomes, and economic modeling considerations.
3. Accelerated Access to Patients
Clear guidance from EMA/NCAs and HTA bodies helps accelerate product development, reducing time to market and improving patient access to innovative therapies.
4. Cost and Risk Mitigation
Avoiding misalignment between regulatory and HTA expectations helps mitigate financial risks, saving resources by eliminating redundant or non-essential trials.
EMA Scientific Advice on certain high-risk medical devices
EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.
Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit their request for advice via a portal and consult the medical device expert panels at different stages of the clinical development. Advice given by the medical device expert panels is a key tool to foster innovation and promote faster patient access to safer and more effective devices.
Manufacturers of high-risk medical devices intended for the treatment of a rare condition should apply for advice via the ongoing pilot programme to support orphan medical devices.
Conclusion
Why Partner with AzurBio Consulting?
AzurBio Consulting is uniquely positioned to bridge regulatory expectations with market access realities. Our team’s expertise in EMA and national scientific advice, combined with deep knowledge of HTA procedures, ensures your drugs development strategy is robust, efficient, and aligned for success.
Start Your European Scientific Advice Journey Today
Ensure your product’s successful journey through regulatory approval and market access processes by leveraging expert EMA/national scientific advice. Contact AzurBio Consulting today to learn how we can optimize your development pathway, align your clinical trials with EMA and HTA expectations, and bring your medicinal products to market faster and more efficiently.