Regulatory Frameworks for the Integration of Quantum Computing in Pharmaceutical R&D: Implications for Drug Development and Compliance Monitoring.

BACKGROUND: Quantum computing (QC) is rapidly developing as an enabling technology that could potentially have major impacts in pharmaceutical drug research and development, but also faces significant challenges in terms of regulation in drug development and drug control contexts. OBJECTIVE: The purpose of this review is to assess different ways that existing pharmaceutical regulations, both within and outside regions such as the EU and US, enable, limit, or necessitate modification for applications throughout the drug development process. METHODS: A regulatory science-based analytical approach was used to examine how existing regulatory instruments, such as the FDA's Emerging Technology, EMA's DARWIN EU, and ICH, measure up to the validation, transparency, and reproducibility imperatives it is believed would emerge from drug development involving quantum technology. Relevant case studies were reviewed to provide context for new governance structures and global regulatory precursors. RESULTS: Although regulators have implemented various flexible pathways-including regulatory sandboxes, model-informed drug development, and adaptive licensing-these mechanisms currently still fail adequately to address the challenges of verification and auditability and the integrity of quantum algorithms for molecular modeling, pharmacogenomics, and pharmacovigilance. The main gaps were identified in ethical oversight, cybersecurity, and model validation standards. CONCLUSION: Coordinated regulatory science will help enable the safe, effective, and regulatory-acceptable use of quantum computing for pharmaceutical R&D. The combination of established standards in guidelines such as ICH E6(R3), GAMP 5, and GDPR with quantum-specific validation and governance pathways could enable responsible innovation while maintaining patient safety, data integrity, and public trust.