New drug clinical trial applications 2020 annual report was published on November 10, 2021, by the China CDE (Center for Drug Evaluation). The online drug platform received a total of 2602 clinical trial applications in 2020 with an increase of 9.1% as compared to 2019.
According to the new drug clinical trial applications 2020 annual report, 1473 applications were for new drugs and 1129 applications were for generic drugs. Under the new drug category, 801 applications (73.6%) were for chemical drugs, 605 applications (23.8%) were for biological products, and 67 applications (4.5%) were chinese medicine and natural drug products.
Although the report points out problem such as homogenization in drug clinical trials, inefficient implementation of clinical trials after approvals, etc., there is still an increasing demand of clinical trial applications for drugs in China.
Further information
Read the original CDE report on new drug clinical trial applications in 2020.
In China, drugs are divided into TCM (Traditional Chinese Medicine), chemical drugs, and biological products for classified management.
As part of the registration of pharmaceuticals, manufacturers must also submit the DMF (Drug Master File) number of the pharmaceutical packaging and ingredients. Cisema can support the applicant during the preparation of the supplementary dossier and the second NMPA technical evaluation.
If you would like to learn more about pre-market registration or post market surveillance for pharmaceutical products in China, contact Cisema.
