On May 15, 2026, China’s National Medical Products Administration (“NMPA”) issued the Implementation Measures for Drug Trial Data Protection (the “Measures”), effective immediately, to formalize China’s protection regime for eligible undisclosed chemistry, manufacturing and control (CMC) and clinical study data submitted in marketing authorization applications. The Measures define the eligible products, protection periods, application process, publication mechanism, and restrictions on follow-on applications that rely on protected data.

Continue Reading China’s NMPA Issues Final Measures on Regulatory Data Protection

For almost a decade, the scientific research provisions of the General Data Protection Regulation (GDPR) have lacked authoritative, European Union (EU)-wide interpretation, leaving sponsors of clinical trials and research institutions alike to navigate a patchwork of national implementing laws. A 2019 study commissioned by the European Data Protection Board (EDPB) — the body comprising EU national data protection authorities — confirmed significant divergence among EU Member States, and interim guidance published in 2021 by the EDPB highlighted — but left unresolved — several key GDPR compliance issues facing organisations in the life sciences industry. In the years since, the COVID-19 pandemic and the United Kingdom’s post-Brexit departure from the EU framework have only sharpened the need for more specific guidance. Ropes & Gray attorneys co-authored an article published in Science magazine in October 2020 that provided a summary of the complexity in this space and potential solutions.

Continue Reading The European Data Protection Board Releases New Guidelines on the Processing of Personal Data for Scientific Research