Real-World Evidence China: draft guidelines on communication for real world evidence to support drug registration applications have now been published by the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).
- These draft guidelines apply to communications when real-world evidence is used to support a drug registration application as key evidence to support efficacy and/or safety evaluation.
- These draft guidelines are based on the trial Guidelines for Real World Evidence to Support Drug Development and Review (Trial) (No. 1, 2020), published by the NMPA on January 7, 2020. The latter introduced the provision for the use of real-world evidence to support drug registration requires adequate communication with the CDE was introduced to ensure that both parties agree on the use of real-world evidence and the conduct of real-world studies.
- The overarching legislation concerning communication meetings was issued by the CDE on December 10, 2020 entitled “Management of Communication for Drug Development and Technical Review” (No. 48 of 2020). Whereas this draft guideline specifies the core issues to be discussed in communication when using real-world evidence to support registration applications, meeting material requirements, etc., and provides recommendations for applicants to carry out communication at key time points to enhance the efficiency of drug clinical development.
- The new draft guideline provides a framework and direction for drug registration applicants on the core issues to be discussed in the communication process in four areas:
- the necessity and feasibility of a real-world study pathway,
- key elements of the study programme,
- applicability of real-world data,
- and transparency of the study.
- According to the specific situation of the research, the drug registration applicant can apply to the CDE for a communication meeting in three stages:
- before the implementation of the research,
- during the research,
- and before submitting the application for listing registration.
- At the end of each meeting, the applicant is required to submit a finalized meeting memo, which will be included in the marketing registration application package.
If you would like to learn more about our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods contact Cisema.