The NMPA, in collaboration with the Chinese Pharmaceutical Association (CPA), issued the 2nd Edition of the Annex Methodological Guidelines for Pharmacoepidemiological Research. The guideline outlines standards for pharmacoepidemiological studies, including data sources, study design, data quality, ethics, and transparent publication.
Key highlights:
- Defines requirements for primary and secondary data integrity
- Details study design principles minimizing bias
- Emphasizes data quality assurance and ethical compliance
- Promotes transparent reporting of research outcomes
This update enhances China’s framework for evaluating real-world evidence and post-marketing safety.
Source
Select Mandate HA
Select Mandate Function