# National Medical Products Administration / Center for Drug Evaluation

Source: https://onco.cc/institutions/nmpa-cde/  
OnCo record `nmpa-cde` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

China's drug regulator and its review centre, whose reforms since 2015 turned China into the world's second-largest source of new cancer drugs and a leader in ADCs and bispecifics.

## Summary

The National Medical Products Administration (formerly CFDA) and its Center for Drug Evaluation regulate medicines in China. Reforms beginning in 2015 cleared a backlog of applications, accepted overseas clinical data, introduced breakthrough, conditional and priority review pathways, and brought China into ICH in 2017, cutting approval times and enabling domestic companies to develop PD-1 antibodies, antibody-drug conjugates, bispecifics and CAR-T at pace. The CDE publishes technical guidelines including those on single-arm trials and oncology endpoints, and its decisions on domestic PD-1s, ivonescimab and Chinese ADCs are followed closely by global companies licensing Chinese assets. Reimbursement is decided separately through the National Reimbursement Drug List negotiations.

## Fields

- Kind: Institution
- Last checked: 2026-09-09
- Also known as: NMPA; CDE; CFDA; China FDA
- City: Beijing, CN
- Type: government
- Website: https://www.cde.org.cn

## Sources

- CDE: https://www.cde.org.cn
- NMPA: https://www.nmpa.gov.cn

## Connected records

- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- drugs: [Disitamab vedotin](https://onco.cc/drugs/disitamab-vedotin/), [Ivonescimab](https://onco.cc/drugs/ivonescimab/), [Mecapegfilgrastim](https://onco.cc/drugs/mecapegfilgrastim/)
- companies: [Akeso](https://onco.cc/companies/akeso/), [BeOne Medicines (formerly BeiGene)](https://onco.cc/companies/beone/), [Sichuan Kelun-Biotech](https://onco.cc/companies/kelun-biotech/)
- institutions: [Cancer Hospital, Chinese Academy of Medical Sciences](https://onco.cc/institutions/cams-cancer-hospital/), [Chinese Society of Clinical Oncology](https://onco.cc/institutions/csco/), [Clinical Data Interchange Standards Consortium](https://onco.cc/institutions/cdisc/), [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [Fudan University Shanghai Cancer Center](https://onco.cc/institutions/fuscc/), [National Cancer Center of China](https://onco.cc/institutions/ncc-china/), [National Healthcare Security Administration](https://onco.cc/institutions/nhsa/), [Sun Yat-sen University Cancer Center](https://onco.cc/institutions/sysucc/)
- people: [Huang Guo](https://onco.cc/people/huang-guo/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/)
- terms: [China Drug Administration Law (2019) and expedited pathways](https://onco.cc/terms/china-drug-administration-law/), [China Human Genetic Resources rules (2019, 2023)](https://onco.cc/terms/china-hgr-rules/), [China National Reimbursement Drug List negotiation and volume-based procurement](https://onco.cc/terms/china-vbp-nrdl/), [ICH good clinical practice (E6)](https://onco.cc/terms/ich-gcp/), [PIPL (China Personal Information Protection Law 2021)](https://onco.cc/terms/pipl/)
- trials: [ORIENT-11](https://onco.cc/trials/orient-11/)

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