Healthcare Author: Mianmian Wang May 10, 2022 08:20 PM (GMT+8)

In the next five years, China will actively boost the development of bioeconomy while adherng to the new Drug Administration Law to meet the rising demand for healthcare and better lives.

Digital medical

Today, National Development and Reform Commission (NDRC) unveiled the five-year plan for bioeconomy which is in line with the requirements of the 14th Five-Year Plan.  

In terms of the development of bioeconomy in the medical industry, the plan stated it will promote the deep integration of advanced technologies such as gene testing and biological genetics for a more accurate early screening of serious diseases such as cancer and cardiovascular diseases. 

It will also promote the iteration of vaccine technology and accelerate the development of genetic engineering vaccines and therapeutic vaccines to enable a better response to severe infectious diseases. 

Meanwhile, the National Medical Products Administration (NMP) released a new document as well and is seeking public advice for the new Drug Administration Law of China. 

The draft states that the law will provide approved medications for rare diseases with maximum seven years of guaranteed market exclusivity if the Marketig Authorization Holder (MAH) guaranteens the supply. If the MHA fails to perform the relevant obligations, the exclusivity will be ceased. 

According to the draft, the law encourages the R&D and innovation of children’s medications. The applicants are recommeded to submit the development plan of the dosage, specification and usage of the children's medication when applying for Premarket Approval (PMA). 

The draft also stipulates that the domestic or overseas R&D of drugs targeting China market shall be performed under the relevant obligations in accordance with the provisions of this Law. 

Key research records and data shall be reliable, accurate, complete, and traceable. The nonclinical safety evaluation of drugs shall be conducted in insititutes certified with Good Laboratory Practice (GLP). The drug preparation for clinical trials shall fulfill the regulations of Good Manufacturing Practice of Medical Products (GMP).