Regulatory updates on China, January 2020

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on February 1st, 2020

Medical Devices
The Medical Device Unique Device Identification (UDI) System is Coming to China

On December 10, 2019 the Unique Device Identification (UDI) system was launched in China in accordance with requirements of ‘Unique Device Identification System Rules’ and ‘Unique Device Identification System Pilot Work Plan’. The UDI system is now open to enterprises to submit UDI related data of their medical devices. Liaoning Province is in the first batch of pilot areas to implement the UDI system with high-risk implantable medical devices such as heart and orthopedic products produced in the province becoming the first batch of pilot submittals. When the UDI system is fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.

Agalsidase Beta for Injection Approved in China for Patients with Rare Fabry Disease

Recently, the China National Medical Products Administration (NMPA) has approved Agalsidase Beta for Injection (trade name: Fabrazyme), which is the first drug approved in China for the treatment of Fabry disease, a rare genetic disease caused by the deficiency of alpha-galactosidase enzyme A. Fabrazyme  suitable for children over the age of 8, adolescents and adults.
The approval is based on the results of overseas clinical trial data, combined with the effectiveness and safety characteristic of the product. Fabrazyme was declared by Sanofi (China) Investment Co., Ltd on behalf of Genzyme Europe B.V., and has been listed in the second batch of NMPA clinically urgently needed new drugs and included it in priority review varieties.

Public Announcement of the Second Round of National Procurement

On January 17, 2020, under the guidance the National Medical Insurance Bureau, the Joint Procurement Office announced winning results of the second batch of national centralized procurement of drugs: A total of 32 varieties were purchased, and a total of 100 products were selected. 122 companies participated in the bidding, resulting in 77 companies being awarded. Compared with 2018 purchase prices, the average price of the proposed bid decreased by 53%. Levocetirizine produced by Jiudian Pharmaceutical had the highest decline by 97.44% and for the “blockbuster” hypoglycemic drugs – Acarbose,Bayer lowered the price 0.8353 CNY/tablet. The reduced prices will help medicare funds to incorporate drugs with more curative effect.

NMPA: Continue Marketing New Drugs and Good Drugs, Promote Consistency Evaluation of Generics

On January 18-19, 2020, the National Conference on Drug Registration Management and Post-Marketing Supervision was held in Beijing, China. At the meeting the China’s National Medical Products Administration (NMPA requested the continued marketing of new drugs and good drugs and promoting consistency in the evaluation of generic drugs. Key tasks for drug registration management in 2020 included:  coordination of national drug registration management work; comprehensive promotion of revision of supporting documents for the newly revised Measures for the Administration of Drug Registration; reforms to the management of Chinese medicine registration; and to promote the inheritance and innovative development of Chinese medicine.

China Approves First ACD Drug

On Jan 21, 2020, Trastuzumab emtansine (trade name Kadcyla) produced by Roche has been approved by the China National Medical Products Administration (NMPA). The Antibody-Conjugated Drug (ACD) fills the gap in the treatment for patients with HER2-positive breast cancer in China who have not achieved complete pathological remission (pCR) after neoadjuvant therapy. Although Kadcyla was first approved by the U.S. Food and Drug Administration (FDA) in February 2013, the new indication approved in China was approved by the FDA and E.U. European Medicines Agency (EMA) in May 2019 and December 2019, respectively. Simultaneous approval with the E.U. and U.S. provides a new option for Chinese patients with HER2-positive early breast cancer and allows Chinese patients to use international innovative drugs as soon as possible.

National Medical Insurance Bureau Issues Special Reimbursement Policy for Novel Coronavirus

Recently, novel coronavirus broke out in China. Against this emergency, The China National Medical Insurance Bureau has issued a special reimbursement policy All medicines and medical service items covered by the ‘New Coronavirus Infected Pneumonia Diagnosis and Treatment Program’ will be temporarily included in the medical insurance fund payment scope, guaranteeing patients’ payment in time. With regard to hospitals under centralized treatment, the government will prepay medical funds to reduce financial stress on these hospitals.

Medical Devices
Four New Coronavirus Nucleic Acid Detection Kits Approved by NMPA for Emergency Response

On January 26, 2020, the China National Medical Products Administration (NMPA) approved four new coronavirus detection kits from four companies (Shanghai ZJ Bio-Tech Co., Ltd, Shanghai GENEODX, BGI Genomics, and MGI Tech Co., Ltd), expanding the supply of new coronavirus detection reagents, to better serve the needs of epidemic prevention and control. Immediately after the outbreak, the NMPA initiated the emergency approval process for medical devices and expedited the review and approval process. Currently, four products including the new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method) and the 2019 new coronavirus nucleic acid sequencing system have been approved. At the same time, provincial drug regulatory departments have been required to strengthen supervision and inspection of the above-mentioned product manufacturing enterprises to ensure product quality and safety. NMPA will continue to adopt special approval procedures for drugs and medical devices needed for epidemic prevention and control and strive for relevant products to be listed as quickly as possible.