A widening of the definition of a gene therapy medicinal product (GTMP) is among the many changes proposed in draft legislation, which once finalized, will reform the EU pharmaceutical legislation.
Wider Gene Therapy Definition In EU Will Require ‘Myth-Busting’ From EMA
The European Commission’s proposed pharma legislation overhaul could expand the definition of a gene therapy medicinal product, posing challenges both from a regulatory and public perception perspective.

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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
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Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such as a requirement for EU countries to prioritize the security of supply over price when procuring drugs.