In 2021, the Chinese regulators focused on the public’s demand for drugs, medical devices and cosmetics as well as the actual development of industries, continued to promote the improvement of the legal and regulatory system, earnestly perform regulatory responsibilities, and promoted the healthy and orderly development of drug and medical device industries. Now, let’s review the ten representative policies related to drugs and medical devices in the extraordinary 2021 as selected by the Public Opinion Monitoring Center of the China Health Media Group.

01

Implementation of the newly revised Regulation on the Supervision and Administration of Medical Devices

to support the high-quality development of the industry

Premier Li Keqiang of the State Council signed Order No. 739 of the State Council on February 9, 2021 to announce the revised Regulation on the Supervision and Administration of Medical Devices (hereinafter referred to the Regulation). The Regulation came into effect on June 1, 2021, and its revision this time was another major revision following the comprehensive revision in 2014 and the partial revision in 2017, with the most important part being the implementation of the medical device registrant system, stipulating that registrants shall be responsible according to the law for the whole life-cycle quality management of medical devices from research and development, production, operation, to use, to further ensure the safety and effectiveness of medical devices.

04

Standardization of medical cosmetology services

through eight authorities joining hands to crack down on illegal services

Eight authorities including the National Health Commission, the Office of the Central Cyberspace Affairs Commission, the Ministry of Public Security, the General Administration of Customs, the State Administration for Market Regulation, the State Post Bureau, the National Medical Products Administration, and the National Administration of Traditional Chinese Medicine jointly issued the Special Rectification Work Plan for Cracking Down on Illegal Medical Cosmetology Services in May 2021, according to which, they decided to jointly launch special rectification to crack down on illegal medical cosmetology services from June to December 2021. The special rectification work had four major tasks, including cracking down on illegal medical cosmetology-related activities, strictly regulating medical cosmetology service behavior, cracking down on illegal manufacturing and sales of drugs and medical devices, and seriously investigating and dealing with illegal advertising and internet information.

05

General Office of the State Council issuing

the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability

The General Office of the State Council issued the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability in May 2021 to define 18 key tasks in six aspects. The six aspects include improving the development of the legal and standard systems; improving the review capacity and optimizing the review mechanism; improving the inspection-related law enforcement system and case handling mechanism and strengthening departmental collaboration; improving inspection and testing capabilities and improving the emergency management system; improving the information-based traceability system and enhancing the “Internet Plus drug regulation” application service level; implementing the Action Plan for Drug Regulatory Science in China and enhancing the quality of regulatory teams and the internationalization of regulation.

09

Eight authorities jointly issuing a document to

regulate volume-based procurement of high-value consumables

Eight authorities including the National Healthcare Security Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance, the National Health Commission, the State Administration for Market Regulation, the National Medical Products Administration, and the Logistics Support Department of the Central Military Commission jointly issued the Guiding Opinions on National Organization of Centralized Volume-based Procurement and Use of High-value Medical Consumables in June 2021 to explore the improvement of the centralized procurement policy, gradually expand the coverage, promote the prices of high-value medical consumables back to reasonable levels, reduce the burden on patients and the transaction costs of enterprises, purify the circulation environment, guide medical institutions to standardize the use, and better support the provision of medical services for all the people who need medical attention.

Source: China Pharmaceutical News (excerpts)