CERSI-PGx works to overcome regulatory challenges in pharmacogenomics, developing proportionate, patient-focused pathways that support the safe and effective use of genetic testing in healthcare. By engaging regulators, industry, and academia, we aim to accelerate adoption of pharmacogenomics in the NHS and promote innovation in the UK.

• What is Regulatory Science?
• Challenges in Pharmacogenomics Regulation
• How CERSI-PGx Supports Implementation
• Stakeholder Collaboration

What is Regulatory Science?

Regulatory science is the study and application of tools, standards, and methods to evaluate the safety, efficacy, quality, and performance of medical products.

Challenges in Pharmacogenomics Regulation

We define industry and regulatory issues, conduct gap analyses, and design pathways for commercial assay accreditation. Our initiatives include a regulatory portal to facilitate access to guidance and streamline testing approval.

How CERSI-PGx Supports Implementation

Regulatory science involves developing new tools, standards, and approaches to assess the safety, efficacy, and quality of medical products. Pharmacogenomics studies how genetic variation affects drug response, enhancing efficacy and safety.

Stakeholder Collaboration

Collaboration with regulators, industry partners, academia, and patients ensures that pathways are practical, proportionate, and patient-focused, enhancing adoption across the UK healthcare system.