China NMPA Applies ICH M14 to Non-Interventional Safety Studies using Real-World Evidence

On January 26, 2026, the National Medical Products Administration (NMPA) issued “Announcement No. 16 of 2026,” published on January 27, 2026, confirming to apply the ICH guideline “M14: General Principles on Planning, Design, Analysis and Reporting of Non-Interventional Studies Using Real-World Data for Safety Assessment of Medicines.”

Alignment with ICH M14 

With this announcement, China formally adopts the ICH M14 framework into its regulatory toolbox for drug safety assessment, supporting continued alignment of China’s drug registration technical standards with international practice under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 

M14 sets out general principles for planning, design, analysis, and reporting of non-interventional pharmacoepidemiologic studies that use real-world data (RWD) to generate real-world evidence (RWE) for safety evaluation. By applying this framework, NMPA sets clearer methodological expectations for sponsors using real-world evidence in China. 

For overseas pharmaceutical companies conducting or planning non-interventional safety studies to support NMPA submissions, this step provides greater regulatory predictability and harmonization with global standards. 

Note: ICH M14 is a methods and reporting standard; it does not by itself authorize acceptance of any given external/overseas dataset. NMPA/CDE will still evaluate data relevance, reliability, and analytic validity case‑by‑case per M14’s framework. 

Scope and Effective Date

As the notice was published on January 27, 2026, studies initiated on or after the announcement’s publication date are expected to conform to M14. 

Sponsors designing non-interventional studies that rely on RWD for safety assessment in China should ensure that study protocols, statistical analysis plans, and reporting are aligned with M14 from the outset. 

Practical Implications for International Applicants 

For marketing authorization holders and overseas sponsors seeking or maintaining access to the China market and intending to use RWE for post-marketing safety evaluation, risk assessment, or supplementary submissions should: 

• Review ongoing and planned non-interventional studies against M14 principles 
• Tighten methodological rigor consistent with ICH expectations
• Monitor CDE technical clarifications and any local implementation notes post-announcement 

In practice, sponsors should align global RWE strategies with China-specific expectations with M14 early — closing gaps before submission or technical review. 

For companies seeking expert guidance on China drug registration and RWD/RWE compliance, Cisema offers specialized pharmaceutical regulatory consulting tailored to manufacturers and sponsors — get in touch with Cisema today to ensure your strategies align with current NMPA and ICH requirements. 

Further Information 

• Explore Cisema’s pharmaceutical consulting services to ensure your China drug registration and real-world evidence strategies align with current NMPA and ICH requirements. 

References 

• Read the National Medical Products Administration Announcement on the Application of the ICH Guideline “M14: Non-Interventional Studies Using Real-World Evidence for Safety Assessment of Medicines — General Principles for Planning, Design, Analysis, and Reporting” (Announcement No. 16 of 2026) (Simplified Chinese)