China Released Draft Amendment on the Regulations of National Essential Medicines List for Public Opinions

On November 15, 2021, National Health Commission (“NHC”) released the “Regulations on National Essential Medicines List (Draft Amendment)” (“Regulations”) for public opinions. The Regulations mentioned that the national essential medicines include a catalog of chemical medicines, biological products, Chinese medicines and children's medicines, etc. Chemical medicines and biological products are mainly classified according to clinical pharmacology, Chinese patent medicines are mainly classified according to function, and children's medicines are mainly classified according to children's specific applicable medicines. 

The highlights of the Regulations are as follow:

1. Adding a new children's medicines list. The category of national essential medicines has been added to the children’s medicines catalog to solve the problems of different levels of children’s medicines in the country, lack of dosage forms, and clinical use of children’s medicines beyond the instructions, etc.

2. The medicines included in the national key monitoring and rational use medicine list will no longer be included in the selection scope of the national essential medicine list. (1) Containing national endangered wild animal and plant medicinal materials; (2) Mainly used for nourishment and health care, easy to abuse, and included in the national key monitoring and rational use of drugs; (3) Due to serious adverse reactions, the national drug regulatory authority clearly stipulates the suspension of production, sale or use; (4) Violation of national laws, regulations, or ethical requirements; (5) Other circumstances specified by the National Essential Medicines Working Committee.

3. The catalog adjustment cycle is changed. The Regulations pointed out that the National Essential Medicine Catalog insists on regular evaluation and dynamic management, and the adjustment cycle should not exceed 3 years in principle. Adjustments can be organized in due course with the approval of the National Essential Medicines Working Committee if necessary.