Talk Innovative Therapies, Precision Medicine & Diagnostics track
S0501 - Overcoming global challenges for Advanced Therapy Medicinal Products through Collaboration, Regulatory Convergence & Reliance
Tue, Mar 18, 2025 · 1:30–2:40 PM CET Boston 1-2 Room, Congress Center Basel
About this session
Regulatory frameworks for ATMPs are rapidly evolving to address the unique nature of these therapeutics. However, many countries lack the expertise and resources to develop a regulatory framework to support timely introduction of ATMPs.
To address this, it is recommended that countries follow WHO considerations on regulatory convergence of Cell and Gene Therapy Products and create flexible legal frameworks that account for current and future modalities. Clear definitions are crucial for determining product classification and the corresponding regulation, especially for the delineation between Human Cell and Tissue products for medical use (HCTs) and ATMPs. Transparent publication of classification decisions is important for consistent regulation.
Access to ATMPs can be delayed in certain countries due to differences in data requirements. For instance, in some situations, country-specific testing or import/export requirements can jeopardize the availability of material needed for patient treatments. Similarly, country specific labeling of the primary packaging could create technical challenges due to the ultralow temperature storages. Lack of alignment in topics, such as GMP for ATMP or GMO requirements, could also create significant roadblock to patient access. Following up on 2023 position paper on convergence and reliance for ATMP, IFPMA has been working on mapping the situation of some of these challenges related across ICH regulatory members. The mapping exercise was further expanded to screen for exceptional situations that can lead to an exemption from a medicinal product marketing authorization procedure. The outcome of this study will be presented and use to stimulate discussion and experience sharing among the participants.
The session will invite participants to discuss options that could be considered to address these challenges, including reliance and/or recognition approaches to enable patients’ access to ATMPs.
Programme:
- 2. Regulator’s efforts towards convergence — Caroline Pothet
- Panel Discussion — Julia Djonova, Asmaa Fouad, Caroline Pothet, Günter Waxenecker, Stuart Beattie
- 3. Overcoming global challenges for Advanced Therapy Medicinal Products through collaboration, regulatory convergence and Reliance — Stuart Beattie
- 1. Introduction — Kowid Ho
Speakers
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Head of the Austrian Medicines and Medical Devices Agency · Austrian Medicines and Medical Devices Agency (AGES)
Panelist
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Biologics & ATMPs Regulatory CMC Early Development Lead, Associate Director · Biogen
Speaker
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Head Central Adm. of Biological, Innov. Products & Clinical Trials · Egyptian Drug Authority
Panelist
