Regulatory Science & Policy
FDA, EMA, ICH guidelines, accelerated approval.
The regulatory environment in 2027 is defined by accelerated approval reform under FDORA, the rolling implementation of the Inflation Reduction Act's Medicare drug price negotiation, and ongoing harmonization through ICH. WCPD 2027 will cover the FDA's post-Aduhelm tightening of confirmatory trial requirements, the new pre-approval inspection expectations for cell and gene therapy facilities, and the EMA's parallel moves on PRIME and conditional marketing authorization. Sessions will also examine the IRA's impact on R&D portfolio decisions, the small-molecule vs biologic price-negotiation timeline asymmetry, PBM reform proposals, and the global divergence on AI/ML-enabled software as a medical device.
- IRA Medicare price negotiation: 2026/2027/2028 selected drugs
- Accelerated approval reform and confirmatory trial mandates
- Cell and gene therapy CMC and pre-approval inspections
- FDA, EMA, PMDA, NMPA harmonization and ICH E6(R3)
- AI/ML-enabled software as a medical device (SaMD)
- PBM reform, 340B, and biosimilar interchangeability
- Real-world evidence in regulatory submissions (21st Century Cures)