National Medical Products Administration (NMPA) Solicits Views on Implementing Regulations of Drug Administration Law of China (Draft Amendments for Comments)

The National Medical Products Administration (NMPA) recently published the Implementing Regulations of Drug Administration Law of China (Draft Amendments for Comments) for public consultation. The draft Amendments were made to facilitate the implementation of the newly revised Drug Administration Law of China and Vaccine Administration Law of China, to further strengthen the supervision and administration of drugs and foster the pharmaceutical industry toward high quality development.

 

The draft Amendments, with expanded contents comprising 181 articles from 80 articles in the current Implementing Regulations of Drug Administration Law (revised in 2019), consolidate the regulatory framework and intellectual property protection measures to encourage pharmaceutical innovation and speed up the accessibility of drugs. In particular, market exclusivity periods are provided for certain new drugs, including first approved drugs in terms of variety, dose form or specification for the use of children; approved new drugs for rare diseases; and first approved chemical generic drugs that have successfully challenged the patent of the relevant brand-name drug.

 

Feedback from the public on the draft Amendments may be directed via email (zfsfgc@nmpa.gov.cn) or by mail to Department of Policies and Regulations of the NMPA before the deadline of 9 June 2022.