National Medical Products Administration (NMPA)
Is Pramlintide legal in China?
Not approvedNot approved in China; only old clinical-stage filings by domestic developers appear in the public register.
Not approved as a medicine here.
CDE's public register lists nine records for pramlintide acetate, filed between 2008 and 2014 by domestic developers (Hainan Zhonghe in 2008, Hanyu Pharmaceutical in 2010 and 2014, and two 2009 records without a named company), all new-drug or supplementary filings and none a marketing application for an approved product. Pramlintide is not on the 2025 national insurance list and we found no NMPA approval, so it cannot lawfully be sold as a medicine in China.
Last verified 2026-09-29 · how we verify
Pramlintide elsewhere
Sources (3)
- 01CDE public register of accepted drug applications (受理品种目录浏览)Center for Drug Evaluation (CDE), NMPA · 2026-09-29 · accessed 2026-09-29
- 02National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug List (2025 edition), effective 2026-01-01National Healthcare Security Administration (NHSA) · 2025-12 · accessed 2026-09-29
- 03Drug Administration Law of the PRC (中华人民共和国药品管理法)National Medical Products Administration (NMPA) · 2019-08-26 · accessed 2026-09-29