China's National Health Commission Releases First Batch of Encouraged Generic Drugs List, Highlighting Oncology and Rare Disease Therapies

On October 9, VCBeat (WeChat ID: vcbeat) learned from the National Health Commission (NHC) that, in order to implement the deployment and requirements set forth in the General Office of the State Council’s “Opinions on Reforming and Improving Policies for the Supply, Assurance, and Use of Generic Drugs” and the 12 departments including the NHC’s “Notice on Issuing the Work Plan to Accelerate the Implementation of Policies for the Supply, Assurance, and Use of Generic Drugs” regarding the formulation of a list of encouraged generic drugs, the NHC, in conjunction with the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the National Medical Products Administration, the China National Intellectual Property Administration, and other departments, organized experts to conduct selection and deliberation. This process focused on drugs whose patents have expired or are about to expire without any registration applications filed, drugs facing clinical supply shortages (due to insufficient competition), and drugs voluntarily declared by enterprises. As a result, the “First Batch of Encouraged Generic Drug List” was formulated. The list includes a total of 33 drug items; the detailed list is provided below.

Most of the drugs on the above list are concentrated in the fields of oncology and hereditary rare diseases, as well as for conditions such as HIV, pulmonary arterial hypertension, Parkinson’s disease, and epilepsy. Anti-cancer drugs, which entail high costs, have long been a key focus of national efforts, while drugs for rare diseases have also become a major priority for the government. Compared with the first batch of recommended lists for generic drug development released in June this year, the current catalog has removed rilpivirine (a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection).

In recent years, more than 95% of the nearly 170,000 drug approval numbers in China have been for generic drugs. While the generic drug industry boasts a wide variety of products, it is characterized by being “large but not strong,” necessitating urgent improvements in quality. To balance the encouragement of innovation with the promotion of generic drug production, China is actively exploring measures to foster R&D innovation, ensure supply stability, and promote clinical use of generic drugs.

In April 2018, the General Office of the State Council issued the “Opinions on Reforming and Improving Policies for the Supply, Assurance, and Use of Generic Drugs,” explicitly calling for the promotion of generic drug research and development (R&D) with a focus on addressing the shortage of high-quality generic drugs. To this end, it proposed the regular formulation and publication of a catalog of drugs encouraged for generic replication, so as to guide enterprises in R&D, registration, and production. The following categories of drugs are primarily encouraged for generic replication: drugs that are clinically essential, have proven efficacy, and face supply shortages; drugs required for the prevention and control of major infectious diseases and for the treatment of rare diseases; drugs needed for responding to public health emergencies; pediatric drugs; and drugs for which no registration application has been submitted one year prior to patent expiration.

Subsequently, in December 2018, the National Health Commission and 11 other departments issued the “Notice on the Work Plan for Accelerating the Implementation of Policies to Ensure the Supply and Use of Generic Drugs,” which explicitly called for accelerating improvements in the quality of marketed drugs and made arrangements and requirements for the formulation of a catalog of encouraged generic drugs.