All departments and bureaus of and entities directly under the National Medical Products Administration:
In order to thoroughly implement the decisions and arrangements of the CPC Central Committee and fully serve and support the overall situation of economic and social development, the work related to further strengthening services for foreign-funded enterprises is hereby notified as follows:
I. To increase the efforts to support enterprises. You should deepen the reforms to streamline administration and delegate power, improve regulation, and upgrade services, take further scientific and effective means and methods in aspects including medical device registration applications, cosmetic registration filing, and regulation, and, while meeting the regulatory needs, fully consider the problems and difficulties faced by enterprises and provide good services for them.
II. To innovate regulatory methods and ways. You should vigorously advance the development of the drug information traceability system and improve the capacity for intelligent regulation over drugs, cosmetics, and medical devices; fully implement the Marketing Authorization Holder (MAH) system, the medical device registrant (filing entity) system, and the cosmetic registrant (filing entity) system; accelerate the building of the Guangdong-Hong Kong-Macao Greater Bay Area (“GBA”), actively implement the Work Plan for Innovative Development of Regulation over Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area, steadily advance the innovative development of regulation over drugs and medical devices in the GBA, and support Hong Kong and Macao MAHs and medical device registrants in having their drugs and medical devices produced by eligible enterprises in the nine mainland cities in the GBA.
III. To accelerate the marketing review and approval of innovative and urgently needed products. You should be oriented by clinical value and, on the premise of ensuring safety, effectiveness, and quality controllability, continue to optimize the review and approval process and increase the review and approval efficiency; give full play to the role of the four fast tracks for drug review and speed up the marketing of urgently-needed overseas new drugs for clinic use, rare disease drugs, pediatric drugs, and drugs for major infectious diseases; accelerate the review and approval of innovative medical device products and fully implement the priority review and approval procedures for innovative medical devices; support the production of imported medical device products by enterprises within China and encourage and support real-world data studies and utilization; continue to improve the building of legal and standard systems for cosmetics, establish and improve the technical review and in-house audit mechanism for cosmetics, study and develop the plan to build a technical support system for safety evaluation of cosmetics, develop technical guidelines for safety evaluation of new raw materials, and preliminarily establish a safety evaluation database.
IV. To advance the implementation of the pharmaceutical patent linkage system. You should, by following the introduced Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes (for Trial Implementation), continue to advance the implementation of the related information disclosure, patent right registration, generic drug patent declaration, judicial linkage and administrative linkage, and first generic market exclusivity period systems, and refine and improve the specific work requirements as required by practice.
V. To actively advance the conversion of international rules. You should strengthen exchange and cooperation on international regulation over drugs, deeply get involved in the development of international regulatory rules, actively convert and implement international technical standards and guidelines, and advance the modernization of regulation through the internationalization of regulation; actively participate in the development and revision of international rules, deeply get involved in the work of related international organizations such as the World Health Organization (WHO), International Coalition of Medicines Regulatory Authorities (ICMRA), International Medical Device Regulators Forum (IMDRF), and International Cooperation on Cosmetics Regulation (ICCR), and advance the conversion and implementation of related guidelines.
VI. To comprehensively strengthen the building of drug regulation capabilities. You should earnestly implement the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability of the General Office of the State Council and accelerate the implementation of the Action Plan for Drug Regulatory Science in China; targeting regulatory needs in the development of new technologies, new products, and new business forms in the medical field, you should focus on the frontiers, highlight priorities, develop and apply a new group of new tools, new standards, and new methods, and improve the capability to solve regulatory problems.
VII. To unblock channels for enterprises to communicate their demands. You should collect enterprise demands and timely sort out the problems encountered by enterprises in registration, filing, production, and operation processes; publicize and interpret regulations and systems in multiple forms such as enterprise symposiums and publicity training sessions and focus on related common problems in the regulation work.
VIII. To further strengthen regulation over drug safety. You should increase regulation over high-risk key products, comprehensively strengthen regulation over the quality of drugs and medical devices for COVID-19 prevention and control, and stick to the combination of special sampling inspections and daily supervision and inspection; increase regulations publicity and training for cosmetic registrants (filing entities) and continue to strengthen regulation over them.
You should earnestly implement the requirements of the “Four Strictest (strictest standards, regulation, punishment and accountability)”, strive to ensure safety and safeguard bottom line, promote development and pursue high line, make every effort to stabilize foreign investment and foreign trade, support the high-quality development of the medical industry, and ensure that excellent results are achieved by the time the 20th National Congress of the CPC is convened.
In order to thoroughly implement the decisions and arrangements of the CPC Central Committee and fully serve and support the overall situation of economic and social development, the work related to further strengthening services for foreign-funded enterprises is hereby notified as follows:
I. To increase the efforts to support enterprises. You should deepen the reforms to streamline administration and delegate power, improve regulation, and upgrade services, take further scientific and effective means and methods in aspects including medical device registration applications, cosmetic registration filing, and regulation, and, while meeting the regulatory needs, fully consider the problems and difficulties faced by enterprises and provide good services for them.
II. To innovate regulatory methods and ways. You should vigorously advance the development of the drug information traceability system and improve the capacity for intelligent regulation over drugs, cosmetics, and medical devices; fully implement the Marketing Authorization Holder (MAH) system, the medical device registrant (filing entity) system, and the cosmetic registrant (filing entity) system; accelerate the building of the Guangdong-Hong Kong-Macao Greater Bay Area (“GBA”), actively implement the Work Plan for Innovative Development of Regulation over Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area, steadily advance the innovative development of regulation over drugs and medical devices in the GBA, and support Hong Kong and Macao MAHs and medical device registrants in having their drugs and medical devices produced by eligible enterprises in the nine mainland cities in the GBA.
III. To accelerate the marketing review and approval of innovative and urgently needed products. You should be oriented by clinical value and, on the premise of ensuring safety, effectiveness, and quality controllability, continue to optimize the review and approval process and increase the review and approval efficiency; give full play to the role of the four fast tracks for drug review and speed up the marketing of urgently-needed overseas new drugs for clinic use, rare disease drugs, pediatric drugs, and drugs for major infectious diseases; accelerate the review and approval of innovative medical device products and fully implement the priority review and approval procedures for innovative medical devices; support the production of imported medical device products by enterprises within China and encourage and support real-world data studies and utilization; continue to improve the building of legal and standard systems for cosmetics, establish and improve the technical review and in-house audit mechanism for cosmetics, study and develop the plan to build a technical support system for safety evaluation of cosmetics, develop technical guidelines for safety evaluation of new raw materials, and preliminarily establish a safety evaluation database.
IV. To advance the implementation of the pharmaceutical patent linkage system. You should, by following the introduced Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes (for Trial Implementation), continue to advance the implementation of the related information disclosure, patent right registration, generic drug patent declaration, judicial linkage and administrative linkage, and first generic market exclusivity period systems, and refine and improve the specific work requirements as required by practice.
V. To actively advance the conversion of international rules. You should strengthen exchange and cooperation on international regulation over drugs, deeply get involved in the development of international regulatory rules, actively convert and implement international technical standards and guidelines, and advance the modernization of regulation through the internationalization of regulation; actively participate in the development and revision of international rules, deeply get involved in the work of related international organizations such as the World Health Organization (WHO), International Coalition of Medicines Regulatory Authorities (ICMRA), International Medical Device Regulators Forum (IMDRF), and International Cooperation on Cosmetics Regulation (ICCR), and advance the conversion and implementation of related guidelines.
VI. To comprehensively strengthen the building of drug regulation capabilities. You should earnestly implement the Implementing Opinions on Comprehensively Strengthening the Building of Drug Regulation Capability of the General Office of the State Council and accelerate the implementation of the Action Plan for Drug Regulatory Science in China; targeting regulatory needs in the development of new technologies, new products, and new business forms in the medical field, you should focus on the frontiers, highlight priorities, develop and apply a new group of new tools, new standards, and new methods, and improve the capability to solve regulatory problems.
VII. To unblock channels for enterprises to communicate their demands. You should collect enterprise demands and timely sort out the problems encountered by enterprises in registration, filing, production, and operation processes; publicize and interpret regulations and systems in multiple forms such as enterprise symposiums and publicity training sessions and focus on related common problems in the regulation work.
VIII. To further strengthen regulation over drug safety. You should increase regulation over high-risk key products, comprehensively strengthen regulation over the quality of drugs and medical devices for COVID-19 prevention and control, and stick to the combination of special sampling inspections and daily supervision and inspection; increase regulations publicity and training for cosmetic registrants (filing entities) and continue to strengthen regulation over them.
You should earnestly implement the requirements of the “Four Strictest (strictest standards, regulation, punishment and accountability)”, strive to ensure safety and safeguard bottom line, promote development and pursue high line, make every effort to stabilize foreign investment and foreign trade, support the high-quality development of the medical industry, and ensure that excellent results are achieved by the time the 20th National Congress of the CPC is convened.
Comprehensive Division of National Medical Products Administration
June 24, 2022
June 24, 2022