This Policy Dividend Cannot be Missed by Medical Workers

On December 12th, the seminar on innovation of medical product review was held, As an important activity of the 2020 Smart Supervision Innovation Conference, the seminar attracted many audiences, and the conference room was packed, and even the audience standing and listening to the lecture was outside the door.

At the meeting, representatives from government, enterprises, academia and research institutes had in-depth discussions on hot topics such as innovation of medical device registration system, wisdom evaluation and real-world data research. Experts attending the meeting believed that with the deepening of the reform of the examination and approval system, many policy dividends were continuously released, which promoted the approval and listing of urgently needed clinical medical devices, and met the people's demand for equipment to a large extent. Experts also reminded that the reform of the examination and approval system is not only the innovation of the regulatory authorities, but also the industry needs to think and improve, strengthen the understanding of policies and regulations, establish a more efficient communication mechanism between government and enterprises, and jointly promote the innovation of medical devices to meet clinical needs.

Review and approval system reform stimulates innovation vitality

"China's medical device industry maintains a rapid development trend, and the global market demand continues to grow. "Du Huiqin, deputy director of the Medical Device Registration Management Department of the State Drug Administration, said at the meeting that in recent years, China's medical device industry has continued to grow and develop, and the regulatory cause has also made great progress, making important contributions to ensuring public use of equipment and promoting industrial innovation and development. In August 2015, the State Council issued the "Opinions on Reforming the Examination and Approval System for Pharmaceutical Medical Devices", which officially kicked off the reform of the examination and approval system; In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices, which further promoted the reform in depth.

In order to implement the spirit of the reform of the review and approval system, the national drug regulatory authorities have issued a series of policy "combination boxing": issuing and implementing the "Special Review Procedures for Innovative Medical Devices" and "Priority Approval Procedures for Medical Devices" to encourage industrial innovation and development; Adhere to scientific supervision and continuously expand the scope of the catalogue of products exempted from clinical trials; Improve the quality of clinical evaluation and reasonably set the requirements of clinical evaluation data; Piloting the medical device registrant system, "unbundling" product registration and production license, and stimulating the vitality of scientific research and innovation; Optimize the licensing matters related to the production of imported medical device products in domestic enterprises in China, save resources of all parties, and improve the efficiency of review and approval; Strengthen standards, classification, naming and coding, and lay a solid foundation for supervision.

The reform of the examination and approval system has achieved remarkable results. Du Huiqin said: "Encouraging innovation and development has achieved remarkable results,Since the implementation of the special approval procedures for innovative medical devices, 98 innovative medical device products have been approved for listing. "

According to Du Huiqin, the pilot system of medical device registrant has been solidly promoted in 22 provinces (autonomous regions and municipalities) including Beijing, Shanghai and Guangdong. As of September 11th this year, 552 products were approved for listing according to the pilot system of medical device registrant, an increase of 493% compared with the end of 2019.

"The construction of UDI system is also progressing in an orderly manner. This year, the pilot work of UDI has achieved important results in the "three medical linkages". "Du Huiqin said that the State Food and Drug Administration has issued the Rules for Unique Identification System of Medical Devices, issued four technical standards, built a unique identification database of medical devices, and jointly carried out UDI pilot work with the National Health and Health Commission and the National Medical Insurance Bureau,The first batch of 9 categories and 69 varieties of the third type of medical devices were included in the first batch of pilot projects.

Informatization means to help wisdom review

After the outbreak of pneumonia in COVID-19, the Medical Device Technology Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Device Evaluation Center) devoted itself to the emergency evaluation work, and completed the evaluation of four products of four enterprises in only four days, creating the speed of "device evaluation" in China.

In this emergency review, the electronic declaration information system (eRPS) for medical device registration plays an important role. The system realizes remote submission of electronic application materials by enterprises and real-time remote online review by reviewers, which reduces the burden of enterprises and the flow of personnel, facilitates enterprises to submit applications, and provides strong support for emergency review.

Wu Kun, director of the Project Management Department of the Equipment Testing Center, introduced at the meeting that on June 24, 2019, the eRPS system was put into operation. ERPS system not only helps to reduce the reporting burden of administrative counterparts, greatly improves the quality of registration reporting materials, and opens up a "highway" for enterprise registration reporting, but also is an important measure for China's medical device supervision to further integrate with international standards.

Wu Kun said that the first batch of online declaration projects include 8 categories, such as the registration of domestic third-class and imported second-class and third-class medical device products, and the change of registration items, covering 98% of the current declaration items.

"Continued registration, changes in registration items, changes in licensing items, and online declarations of product registration are far greater than the offline declarations of these projects, indicating that registration applicants have basically used to submit registration applications through the eRPS system. "Wu Kun said that by the end of November this year, eRPS system had received more than 40,000 applications for registration of various medical devices, among which applicants submitted more than 37,000 applications online, accounting for more than 90%.

The emergency review during the pneumonia epidemic in COVID-19 is a big test on the effectiveness of the reform of medical device review and approval system, and the device review center has delivered an excellent answer. In the process of reforming the examination and approval system of medical devices, the center optimized the electronic process of examination and approval, and promoted and implemented 15 systems including electronic declaration, filing examination, intelligent distribution, expert consultation and collective decision-making.

"When the reform is not completed, the re-evaluation of 15 new evaluation systems is a key work of CERN in 2020 . Electronic declaration and review electronic process are the basis of intelligent review, and the center will introduce more information means to help realize intelligent review. "Wu Kun said.

Real-world data applications are moving forward in exploration

"I am a representative from an enterprise and want to ask a question about real-world data research ... "During the discussion session, a delegate raised his hand to ask questions. After the meeting, he took the initiative to ask experts for advice. In fact, there are not a few people from the industry who come to the seminar to learn from the experience. The application of real-world data is a hot topic, and it is also a topic mentioned many times by participating experts during this conference.

In April 2019, the State Food and Drug Administration initiated the implementation of the China Drug Regulatory Science Action Plan, and "Methodological Research on the Clinical Evaluation of Medical Devices with Real World Data" was among the first nine key research projects; In June, the State Food and Drug Administration and the Hainan Provincial Government jointly launched the pilot project of clinical real-world data application in Hainan; In September, "Implementation Plan of Clinical Real World Data Application Pilot Work in Lecheng International Medical Tourism Pioneer Zone, Boao, Hainan" and other documents were released to promote the pilot landing.

On November 26 this year, the State Food and Drug Administration issued the "Technical Guiding Principles of Real World Data for Clinical Evaluation of Medical Devices (Trial)", which clarified the specific requirements of real world data for clinical evaluation of medical devices; On November 27th, the Scientific Research Base of Drug and Medical Device Supervision of State Food and Drug Administration was established in Boao.

"The establishment of a regulatory scientific research base is only the beginning,The key is to think about how to better carry out research work in the next step. "Li Yaohua, director of Hainan Drug and Medical Device Evaluation Service Center, introduced that the regulatory scientific research base will carry out clinical real-world data research around the special policy of urgently needed imported drugs and medical devices in Boao Lecheng Medical Tourism Pioneer Zone (hereinafter referred to as Pioneer Zone).

Li Yaohua said that real-world data research is helpful to establish a new clinical confirmation method for evaluating the safety and effectiveness of medical instruments. "Real-world evidence can be used as a useful supplement to traditional clinical trial evidence. When using real-world data as clinical evaluation evidence, the regulatory authorities will not lower the requirements and standards for clinical evidence. "

According to the relevant person in charge of Aijian Company, Qiao Yadeng, a medical and aesthetic product of the company, has been approved by Hainan Provincial Food and Drug Administration and tried first in the pioneering area.

This is mainly due to the approval authority granted by the State Council to Hainan Province in 2018 to import medical devices and drugs (excluding vaccines) which are urgently needed clinically.

According to Chief Physician Wang Danru, deputy director of the Department of Orthopedic Surgery, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Qiao Yadeng is a sodium hyaluronate product used to improve the capacity of chin and jaw face. In December, 2019, the team of reconstructive surgery experts in his hospital completed the first injection operation in China to improve the capacity of chin and jaw.

Wang Danru said that the global innovative products will be tested first in the pioneering area, which will not only benefit Chinese patients from the global advanced medical devices, but also help the healthy and benign development of the medical and aesthetic industry.