[New Express]Guangdong Drug Administration’s “triple” innovative service has achieved remarkable results and continues to help the high-quality development of the province’s biopharmaceutical industry

　　■The scene of the press conference

New Express reporter Lu Yansi, correspondent of the Guangdong Drug Administration reported that on the morning of May 12, the Guangdong Provincial Drug Administration held a special press conference. Yan Zhen, member of the Party Group and Deputy Director of the Provincial Drug Administration, announced that the “three-level” (biopharmaceutical industry) will be launched in 2021. Key projects, key enterprises, key regions) innovation service results, released the third batch of “triple” innovation service list.

It is reported that up to now, the province has more than 240,000 “two products and one machine” certified production and operation enterprises, ranking first in the country; the total production and circulation value of “two products and one machine” exceeds one trillion yuan, ranking first in the country. become a strategic pillar industry. The province has 97 newly approved drugs, 25 innovative medical devices, 2,943 licensed cosmetic manufacturers, and 1.63 million registered cosmetic products, all of which are at the forefront of the country.

Yan Zhen introduced that in 2021, the Guangdong Provincial Drug Administration will give full play to the advantages of the frontier position of reform and opening up, further promote the comprehensive reform of the modernization of the drug regulatory system and regulatory capacity, creatively research and propose “three-fold” innovative service reform measures, and formulate and release the “Guangdong Provincial Drug Administration”. Supervision and Administration of Biopharmaceutical Industry Key Projects, Key Enterprises, and Key Regions of the Innovation Service Management Measures, has released two batches of lists of 19 key projects, 15 key companies and 5 key regions. By building a convenient service platform, The company provided a series of support and assistance methods, which have transformed a number of project results, and achieved phased progress and remarkable results. It mainly includes the following four aspects:

The first is to focus on tackling key problems and make every effort to ensure the “blocking war” of epidemic prevention and control. Up to now, the number of new coronavirus detection reagents, ventilators, medical masks, protective clothing, and infrared thermometers that have been approved and registered in the province ranks first in the country. Including promoting the emergency use and marketing of vaccine products of Shenzhen Kangtai Biological Products Co., Ltd., assisting Zhuhai Livzon Mab Biotechnology Co., Ltd.’s vaccine products to apply for conditional production and marketing to the State Food and Drug Administration, and promoting the transformation of Guangdong Yifang Pharmaceutical Co., Ltd. Shibaidu Granules were approved for registration and listing, etc., and the emergency review and approval ran out of the “Guangdong Speed”. At the same time, it has stepped up efforts to explore and improve the supervision of emergency use of vaccines, concentrated superior forces, formulated inspection points, and established a working mechanism. 37 special supervision and inspection teams with a total of 151 inspectors were dispatched to conduct on-site inspections, and experts were dispatched to give guidance. The output of vaccines increased from the initial 247 10,000 doses/month increased to 13.24 million doses/month. A total of 28 vaccine distribution companies, 305 CDCs, and 8,538 vaccination units were inspected across the province. Strict supervision and inspection set up “Guangdong Standard”.

The second is to increase speed and efficiency, and open a “fast track” for innovative projects to be listed. Promoted BeiGene (Shanghai) Biotechnology Co., Ltd. to hold tislelizumab injection and added Guangzhou BeiGene Pharmaceutical Co., Ltd. as a trusted manufacturer. The approval time was less than 100 working days, becoming the first drug to be launched in China Cases where license holders were approved to increase the entrusted production enterprises and production addresses of biological products; the collar-type artificial cornea project of Guangdong Jiayue Meishi Biotechnology Co., Ltd. was approved for listing in October 2021, becoming the first domestic artificial cornea with independent intellectual property rights. Cornea, breaking the technical barriers of foreign countries, achieving a “zero breakthrough” in domestic artificial corneas, and solving the problem of “stuck neck” in ophthalmic products; Zhongshan Kangfang Biopharmaceutical Co., Ltd.’s “Piamprimab Injection” project was approved It became the first innovative anti-PD-1 monoclonal antibody drug in the Guangdong-Hong Kong-Macao Greater Bay Area; the innovative traditional Chinese medicine “Huzhen Qingfeng Capsule” of Yili Pharmaceutical Co., Ltd. was successfully approved for marketing; Shenzhen Hannuo Medical Technology Co., Ltd., Significant progress has been made in innovative medical device projects urgently needed by the epidemic, such as the Extracorporeal Membrane Oxygenation (ECMO) project of Dongguan Kewei Medical Devices Co., Ltd.

The third is to solve difficulties and bail out, and break the “bottleneck” of enterprises to become better and stronger. Conduct scientific demonstrations for Guangzhou Pharmaceutical Co., Ltd. and Kangze Pharmaceutical Co., Ltd. to build a modern pharmaceutical intelligent logistics center, provide professional advice and guidance, and effectively ensure the scientific, rational and standardized construction of the intelligent logistics center; In the clinical development work of “Cadonilimumab Injection” developed by Fang Biopharmaceutical Co., Ltd., inspectors were dispatched to work overtime to carry out on-site registration verification and GMP compliance inspection, which won time and opportunities for the new drug to be launched this year; The Pharmaceutical Co., Ltd. successfully passed the customs AEO advanced certification, and obtained a green pass for the import of medical equipment in the future; it gave priority to the application for production license change and the filing of key products for Zhongshan Zhongyan Cosmetics Co., Ltd., and vigorously promoted the largest single skin care product factory in China. Completed and put into production.

Fourth, go hand in hand to draw the “concentric circles” of regional industrial development.

The Provincial Institute for Drug Control and Huangpu District cooperated to build a drug safety evaluation center, established a new model of collaborative supervision between provinces and regions, and realized the “submission of inspection in the sampling area of ​​the district bureau” for drug registration inspection, and the inspection period was shortened from the previous 6 months to 1. Within a month; promote the development of Chinese medicine preparations for medical institutions in the Hengqin Guangdong-Macao Industrial Park by TCM medical institutions in the province, establish the “Guangdong-Macao Medical Institution Traditional Chinese Medicine Preparation Center”, and obtain the “Medical Institution Preparation License”, “Yiqi Ganlu Granules” obtained The first filing document number; vigorously promote the construction of the Greater Bay Area Center for Drug Evaluation and Inspection of the State Food and Drug Administration and the Greater Bay Area Center for Medical Device Technology Review and Inspection of the State Food and Drug Administration, and promote the construction of the largest biomedical safety evaluation laboratory in the Greater Bay Area , to help the high-quality development of the biopharmaceutical industry in the Qianhai Cooperation Zone.

At the press conference, the third batch of “triple” innovative service list of the Provincial Drug Administration was also announced: a total of 8 innovative drugs, 4 innovative medical devices and 1 new cosmetic raw material projects were listed as key projects; involving Guangzhou, Shenzhen, A total of 13 pharmaceutical, medical device and cosmetic manufacturers in Foshan, Dongguan, Huizhou, Zhaoqing, Zhanjiang and other places were listed as key enterprises.