On February 28, 2021, the international community observes the 14th Rare Disease Day, which is a time of the year to raise awareness among the general public and to also reflect upon the progress of orphan drugs development. There are approximately 7,000 existing rare diseases in the world, and less than 10% of them have […]

On Dec 30, 2020, the National Health Commission (NHC) announced the list of second batch of encouraged generic drugs, including 19 drugs in which patents are about to expire in 2021 and 2022. The list is selected collectively by the National Health Commission (NHC), Ministry of Science and Technology (MOST), Ministry of Industry and Information […]

The Pharmacopoeia of the People’s Republic of China 2020 Edition (hereinafter referred to as the Chinese Pharmacopoeia) officially comes into force on Dec 30, 2020.   Since Dec 30, 2020, for all varieties of medicines that have been included in former versions of pharmacopoeia and standard promulgated by China bureau-level and ministerial-level units, if they […]

On Dec. 21, 2020, China Ministry of Finance published the 2021 Tariff Adjustment Plan (hereafter referred to as “the Plan”). The Plan adjusts the provisional tariff rates and conventional tariff rates for some import products in order to respond to the Dual Circulation, a new development pattern raised by President Xi in May. The provisional […]

On Dec 28th, 2020, the National Healthcare Security Administration (NHSA) and Ministry of Human Resources and Social Security (MOHRSS) together issued the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2020 Edition), hereinafter referred to as the 2020 NRDL. It includes a total of 2800 medicines, including 1264 traditional Chinese […]

Introduction: Following the new Version of Measures for the Administration of Drug Registration, the new re-registration procedures for drugs manufactured overseas have been more detailed. This revision clearly stipulates that no supplementary application can be filed during the re-registration period, and clarifies the authority of supplementary application and re-registration. On September 15, the Center for […]

Abstract: most drugs are used for rare diseases. To implement the policies set forth in the State Council executive meetings and speed up the entry of overseas new drugs urgently needed in clinical practice to China, according to the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Urgently Needed in […]

Let’s talk about the difference between the National Health Commission of the People’s Republic of China, the National Healthcare Security Administration and the National Medical Products Administration. And these three ministries have the closest relationship with our medical personnel. From the perspective of the functions of ministries, the Health Commission has the closest relationship with […]

The fourth batch of centralized procurement of drugs is expected to be officially launched around February 2021. While covering diabetes, hypertension, respiratory disease, psychotherapy, cancer, fungal infections, anesthesia pain, eye drops, and other drug areas, this centralized procurement mainly focuses on oral products, along with eight injection products. It is noteworthy that the fourth batch […]

On Dec 10, 2020, National Healthcare Security Administration (NHSA) replied that among more than 50 orphan drugs currently on the market with indications, more than 40 drugs of them have been included in the National Reimbursement Drug List (NRDL). China has published five versions of the NRDL so far, increasing the number of medicines from […]