Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial
Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial
2 PagesThe European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex, with approval pathways dependent on product classification by the EMA's Committee for Advanced Therapies (CAT). Premier Research assisted a European ATMP developer with a Phase 2a study in six countries, involving a genetically modified naked DNA plasmid classified as a gene therapy medicinal product. To streamline regulatory submissions and avoid lengthy GMO approvals, Premier Research developed a documented risk assessment and rationale to persuade authorities in four countries that additional GMO approvals were unnecessary.
