Arnold & Porter
7 Experts
1 Contributions by Arnold & Porter Experts
PRACTICE NOTES
Advances in medicine, biomicrobiology and biotechnology have given rise to a state-of-the-art group of medicinal interventions that deploy gene therapy, somatic cell therapy and engineered tissues to prevent, manage or even cure human disease. The newness, intricacy and variety of these products has required fresh regulatory instruments, both legislative measures and guidance, to strike an appropriate balance between risks and patient benefits. In the EU and the UK, lawmakers classify this group as ‘advanced therapy medicinal products (ATMPs)’ to safeguard the highest standards of public health while recognising their unique challenges, particularly around clinical trials, manufacturing and pharmacovigilance. Yet oversight of genetically modified organisms (GMOs) used as starting materials for ATMPs remains a national matter and therefore varies from one Member State to the next. These divergences have produced a complicated regulatory environment for ATMPs. Oversight of tissues and cells is likewise
Life Sciences
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