The latest development of the "Hong Kong and Macau Medicines and Equipment Links"!

Medical News, August 31, August 27, Guangdong Provincial Food and Drug Administration and Guangdong Provincial Health Commission held a special press conference
.
Su Shengfeng, a member of the Party Group of the Guangdong Provincial Drug Administration, notified the pilot work of the "Hong Kong and Macau Medicine and Equipment Exchange" at the meeting, and introduced the main supporting system documents of the "Hong Kong and Macau Medicine and Equipment Exchange" policy and the formal expansion implementation work arrangements
.
Zhou Zixiao, member of the Party Group and Deputy Director of the Guangdong Provincial Health Commission, introduced the latest developments in designated medical institutions, and Qiu Nan, Director of the Administrative Licensing Division of the Guangdong Provincial Food and Drug Administration, introduced the policy of “simplifying the registration and approval of traditional Chinese patent medicines for external use in Hong Kong and Macau”.
, Li Xuejun, director of the Pharmaceutical Affairs Department of the Guangdong Provincial Health Commission, participated in the Q&A session
.
The press conference was presided over by Lin Ying, director of the Office of the Guangdong Provincial Drug Administration
.

 

It is understood that since the “Hong Kong and Macau Medicines and Devices ” policy pilot program started in January this year, 9 imported drugs and 2 medical devices have been approved for urgent clinical use , benefiting 150 patients in total
.
At the same time, clarify the list of the first batch of designated medical institutions in the Mainland for policy expansion, specifically: The University of Hong Kong Shenzhen Hospital (tertiary hospital, pilot hospital), Guangzhou Modern Hospital (secondary hospital), Guangzhou United Family Hospital (secondary hospital), Zhuhai Ximalin Shunchao Eye Hospital (second-level hospital) and Zhongshan Chenxinghai Hospital (third-level hospital)
.

 

　　Source: Official WeChat Account of Hong Kong University Shenzhen Hospital

 

　　Approved much-needed clinical use of imported Medical Device 11 Ge

 

　　In order to implement the "Innovative Development Work Plan for Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area" (hereinafter referred to as the "Plan") issued by 8 ministries and commissions including the State Administration for Market Regulation and the State Drug Administration The designated medical institutions operating in the city use urgently needed clinically needed drugs that have been marketed in Hong Kong and Macau, and use urgently needed clinically needed medical devices that have been purchased and used by public hospitals in Hong Kong and Macau and have advanced clinical applications.
" Under the overall planning and promotion of the joint conference system of Guangdong, Guangdong, Guangdong, Hong Kong and Macao Greater Bay Area for the innovation and development of drug and medical device supervision, the Guangdong Drug Administration takes the lead in coordinating with the Provincial Health Commission, the Guangdong Branch of the General Administration of Customs and other relevant departments and Shenzhen , Organized and carried out the pilot policy of "Hong Kong and Macao Medicine and Equipment Communication" in the Shenzhen Hospital of the University of Hong Kong
.
At present, the pilot work has been completed and good results have been achieved.
It is planned to extend the experience and practices obtained in the pilot to other cities and designated medical institutions that meet the requirements in the Guangdong-Hong Kong-Macao Greater Bay Area
.

 

　　Su Shengfeng said, “Since the launch of the “Hong Kong and Macau Medicines and Devices” policy trial in January this year, 9 imported drugs and 2 medical devices have been approved for clinical urgent use, benefiting 150 patients
.
Among them, there are many of them.
Newer anti-cancer drugs in the world such as Nigeria
.
” During the pilot period, the Guangdong Drug Administration took the lead in establishing a traceability management system for the whole process.
The University of Hong Kong Shenzhen Hospital as a pilot medical institution further explored and established the storage and use management of related drugs and medical devices.
The pilot distribution companies have established proprietary management standards and operating procedures and formed a system
.
The evaluation results of the pilot work organized by a third-party organization show that the "Hong Kong-Macao medicine and equipment exchange" policy pilot work has established a sound management mechanism, the responsibilities of the cooperative departments are clear, the work process is smooth and orderly, and the product safety risk is controllable, which can effectively promote Guangdong, Hong Kong and Macao.
The process of "homogenization" of medical quality in the Greater Bay Area has a foundation that can be replicated and promoted
.

 

　　It is understood that, in order to formally expand the implementation of the "Hong Kong-Macao Medicines and Equipment Exchange" policy in the 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area, based on the comprehensive summary of the pilot work experience, the Guangdong Provincial Drug Administration took the lead in organizing the formulation and distribution of the "Guangdong-Hong Kong-Macao Greater Bay Area".
The region urgently needs to import Hong Kong and Macao medicines and medical devices management interim regulations and other policy supporting system documents, which clarify the specific contents and requirements of the designated medical institutions, the scope of imported medical equipment, the approval mode, the responsibilities of all parties, and risk control
.
The formulation and promulgation of the policy documents will establish a standardized management system for urgently needed drugs and medical devices for the formal implementation of the "Hong Kong and Macau Medicines and Devices Communication" policy, and provide clear guidance for all participants including medical institutions and distribution companies, and provide a clear guideline for policymakers in 9 cities in the Greater Bay Area.
The extended implementation provides institutional guarantees
.

 

　　Identify the 5 first batch of designated medical institutions in the Mainland

 

　　According to Zhou Zixiao, “At present, the Guangdong Provincial Health Commission considers the qualifications of medical institutions, the level of cooperative medical care, and the form of ownership and management, and organizes implementation in accordance with the three steps of medical institution declaration, provincial health commission review and research and determination.
The selection and review determined the 5 first batch of designated medical institutions in the Mainland, involving 2 in Guangzhou, 1 in Shenzhen, Zhuhai, and Zhongshan
.
Specifically: The University of Hong Kong Shenzhen Hospital (a tertiary hospital, a pilot hospital), and Modern Hospital Guangzhou (a second-level hospital) hospital), Guangzhou United family hospital (two hospitals), beads Haisch Marlin Chao-shun Eye hospital (two hospitals) and Zhongshan Chen Xinghai hospital (tertiary hospitals)
.
"Next, the Guangdong Provincial health health Committee will be the first good guidance On the basis of the implementation of policies and regulations by designated medical institutions in the Mainland, combined with the actual use of drugs and medical devices listed in Hong Kong and Macao that are urgently needed for clinical use in the Mainland, timely research will be carried out to supplement the next batch of designated medical institutions
.

 

　　The press conference also introduced the specific content of the "plan" related to the "simplification of the import registration approval process for traditional Chinese patent medicines listed in Hong Kong and Macau", and simultaneously publicly released the "Announcement on Simplifying the Registration and Approval of Traditional Chinese Patent Medicines Listed in Hong Kong and Macau for External Use" "(Hereinafter referred to as "Announcement")
.

 

　　Qiu Nan, Director of the Administrative Licensing Division of the Guangdong Provincial Food and Drug Administration, said, “In order to simplify the registration and approval process of traditional Chinese patent medicines for external use on the market in Hong Kong and Macau (hereinafter referred to as Hong Kong and Macao proprietary Chinese medicines for external use), and to solve the convergence of drug usage habits in Guangdong, Hong Kong and Macau, the drug registration management system For different issues, the Guangdong Provincial Food and Drug Administration, on the basis of fully listening to the opinions of the Hong Kong and Macao industries, combined with the characteristics of Hong Kong and Macao's external use of proprietary Chinese medicines for many years, widespread use by the masses, and relatively high safety of topical pharmaceuticals, research and formulation of corresponding policies and measures, and It is supported by the State Drug Administration and Hong Kong and Macau drug regulatory authorities
.
"

 

　　Specific policies and measures include: (1) Adjusting the powers of examination and approval
.
The registration and approval items of proprietary Chinese medicines for external use in Hong Kong and Macau include listing registration, post-marketing changes and re-registration, which were reviewed by the State Drug Administration and adjusted to simplified approval by the Guangdong Drug Administration
.
(2) Streamline the application materials
.
Based on the actual listing and use of proprietary Chinese medicines for external use in Hong Kong and Macau as important evidence, and following the characteristics of proprietary Chinese medicines for external use, clinical trial data for drugs can no longer be provided
.
In order to avoid repeating relevant experimental research, the experimental research data submitted when the original Chinese patent medicines for external use in Hong Kong and Macao were originally registered in Hong Kong and Macao can be provided as the corresponding application materials
.
(3) Simplify the approval process
.
Approval of listing registration, through the docking of Guangdong, Hong Kong and Macao drug regulatory mechanisms, can reduce the production site inspection and system verification links in the approval process
.
Approval of changes after listing, if the relevant changes are approved in Hong Kong and Macau, you can apply for adjustment of the approval process instead of filing
.
(4) Shorten the approval time
.
The technical review of the listing registration approval was reduced from the original 200 working days to 80 working days, and the total approval time was reduced from the original 235 days to 115 days.
The approval time was reduced by half; the approval and re-registration time limits were changed after the listing.
It also reduced 50 days respectively, further shortening the approval time and speeding up the approval process
.
(5) Optimize examination and approval services
.
Comprehensive policy advisory services have been opened to facilitate Hong Kong and Macao enterprises to familiarize themselves with the Mainland Chinese patent medicine registration management policies and obtain guidance on simplified registration approval policies
.

　　Medical News, August 31, August 27, Guangdong Provincial Food and Drug Administration and Guangdong Provincial Health Commission held a special press conference
.
Su Shengfeng, a member of the Party Group of the Guangdong Provincial Drug Administration, notified the pilot work of the "Hong Kong and Macau Medicine and Equipment Exchange" at the meeting, and introduced the main supporting system documents of the "Hong Kong and Macau Medicine and Equipment Exchange" policy and the formal expansion implementation work arrangements
.
Zhou Zixiao, member of the Party Group and Deputy Director of the Guangdong Provincial Health Commission, introduced the latest developments in designated medical institutions, and Qiu Nan, Director of the Administrative Licensing Division of the Guangdong Provincial Food and Drug Administration, introduced the policy of “simplifying the registration and approval of traditional Chinese patent medicines for external use in Hong Kong and Macau”.
, Li Xuejun, director of the Pharmaceutical Affairs Department of the Guangdong Provincial Health Commission, participated in the Q&A session
.
The press conference was presided over by Lin Ying, director of the Office of the Guangdong Provincial Drug Administration
.

 

　　It is understood that since the “Hong Kong and Macau Medicines and Devices ” policy pilot program started in January this year, 9 imported drugs and 2 medical devices have been approved for urgent clinical use , benefiting 150 patients in total
.
At the same time, clarify the list of the first batch of designated medical institutions in the Mainland for policy expansion, specifically: The University of Hong Kong Shenzhen Hospital (tertiary hospital, pilot hospital), Guangzhou Modern Hospital (secondary hospital), Guangzhou United Family Hospital (secondary hospital), Zhuhai Ximalin Shunchao Eye Hospital (second-level hospital) and Zhongshan Chenxinghai Hospital (third-level hospital)
.

 

　　

　　Source: Official WeChat Account of Hong Kong University Shenzhen Hospital

 

　　Approved much-needed clinical use of imported Medical Device 11 Ge

 

　　In order to implement the "Innovative Development Work Plan for Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area" (hereinafter referred to as the "Plan") issued by 8 ministries and commissions including the State Administration for Market Regulation and the State Drug Administration The designated medical institutions operating in the city use urgently needed clinically needed drugs that have been marketed in Hong Kong and Macau, and use urgently needed clinically needed medical devices that have been purchased and used by public hospitals in Hong Kong and Macau and have advanced clinical applications.
" Under the overall planning and promotion of the joint conference system of Guangdong, Guangdong, Guangdong, Hong Kong and Macao Greater Bay Area for the innovation and development of drug and medical device supervision, the Guangdong Drug Administration takes the lead in coordinating with the Provincial Health Commission, the Guangdong Branch of the General Administration of Customs and other relevant departments and Shenzhen , Organized and carried out the pilot policy of "Hong Kong and Macao Medicine and Equipment Communication" in the Shenzhen Hospital of the University of Hong Kong
.
At present, the pilot work has been completed and good results have been achieved.
It is planned to extend the experience and practices obtained in the pilot to other cities and designated medical institutions that meet the requirements in the Guangdong-Hong Kong-Macao Greater Bay Area
.

 

　　Su Shengfeng said, “Since the launch of the “Hong Kong and Macau Medicines and Devices” policy trial in January this year, 9 imported drugs and 2 medical devices have been approved for clinical urgent use, benefiting 150 patients
.
Among them, there are many of them.
Newer anti-cancer drugs in the world such as Nigeria
.
” During the pilot period, the Guangdong Drug Administration took the lead in establishing a traceability management system for the whole process.
The University of Hong Kong Shenzhen Hospital as a pilot medical institution further explored and established the storage and use management of related drugs and medical devices.
The pilot distribution companies have established proprietary management standards and operating procedures and formed a system
.
The evaluation results of the pilot work organized by a third-party organization show that the "Hong Kong-Macao medicine and equipment exchange" policy pilot work has established a sound management mechanism, the responsibilities of the cooperative departments are clear, the work process is smooth and orderly, and the product safety risk is controllable, which can effectively promote Guangdong, Hong Kong and Macao.
The process of "homogenization" of medical quality in the Greater Bay Area has a foundation that can be replicated and promoted
.

 

　　It is understood that, in order to formally expand the implementation of the "Hong Kong-Macao Medicines and Equipment Exchange" policy in the 9 cities in the Guangdong-Hong Kong-Macao Greater Bay Area, based on the comprehensive summary of the pilot work experience, the Guangdong Provincial Drug Administration took the lead in organizing the formulation and distribution of the "Guangdong-Hong Kong-Macao Greater Bay Area".
The region urgently needs to import Hong Kong and Macao medicines and medical devices management interim regulations and other policy supporting system documents, which clarify the specific contents and requirements of the designated medical institutions, the scope of imported medical equipment, the approval mode, the responsibilities of all parties, and risk control
.
The formulation and promulgation of the policy documents will establish a standardized management system for urgently needed drugs and medical devices for the formal implementation of the "Hong Kong and Macau Medicines and Devices Communication" policy, and provide clear guidance for all participants including medical institutions and distribution companies, and provide a clear guideline for policymakers in 9 cities in the Greater Bay Area.
The extended implementation provides institutional guarantees
.

 

　　Identify the 5 first batch of designated medical institutions in the Mainland

 

　　According to Zhou Zixiao, “At present, the Guangdong Provincial Health Commission considers the qualifications of medical institutions, the level of cooperative medical care, and the form of ownership and management, and organizes implementation in accordance with the three steps of medical institution declaration, provincial health commission review and research and determination.
The selection and review determined the 5 first batch of designated medical institutions in the Mainland, involving 2 in Guangzhou, 1 in Shenzhen, Zhuhai, and Zhongshan
.
Specifically: The University of Hong Kong Shenzhen Hospital (a tertiary hospital, a pilot hospital), and Modern Hospital Guangzhou (a second-level hospital) hospital), Guangzhou United family hospital (two hospitals), beads Haisch Marlin Chao-shun Eye hospital (two hospitals) and Zhongshan Chen Xinghai hospital (tertiary hospitals)
.
"Next, the Guangdong Provincial health health Committee will be the first good guidance On the basis of the implementation of policies and regulations by designated medical institutions in the Mainland, combined with the actual use of drugs and medical devices listed in Hong Kong and Macao that are urgently needed for clinical use in the Mainland, timely research will be carried out to supplement the next batch of designated medical institutions
.

 

　　The press conference also introduced the specific content of the "plan" related to the "simplification of the import registration approval process for traditional Chinese patent medicines listed in Hong Kong and Macau", and simultaneously publicly released the "Announcement on Simplifying the Registration and Approval of Traditional Chinese Patent Medicines Listed in Hong Kong and Macau for External Use" "(Hereinafter referred to as "Announcement")
.

 

　　Qiu Nan, Director of the Administrative Licensing Division of the Guangdong Provincial Food and Drug Administration, said, “In order to simplify the registration and approval process of traditional Chinese patent medicines for external use on the market in Hong Kong and Macau (hereinafter referred to as Hong Kong and Macao proprietary Chinese medicines for external use), and to solve the convergence of drug usage habits in Guangdong, Hong Kong and Macau, the drug registration management system For different issues, the Guangdong Provincial Food and Drug Administration, on the basis of fully listening to the opinions of the Hong Kong and Macao industries, combined with the characteristics of Hong Kong and Macao's external use of proprietary Chinese medicines for many years, widespread use by the masses, and relatively high safety of topical pharmaceuticals, research and formulation of corresponding policies and measures, and It is supported by the State Drug Administration and Hong Kong and Macau drug regulatory authorities
.
"

 

　　Specific policies and measures include: (1) Adjusting the powers of examination and approval
.
The registration and approval items of proprietary Chinese medicines for external use in Hong Kong and Macau include listing registration, post-marketing changes and re-registration, which were reviewed by the State Drug Administration and adjusted to simplified approval by the Guangdong Drug Administration
.
(2) Streamline the application materials
.
Based on the actual listing and use of proprietary Chinese medicines for external use in Hong Kong and Macau as important evidence, and following the characteristics of proprietary Chinese medicines for external use, clinical trial data for drugs can no longer be provided
.
In order to avoid repeating relevant experimental research, the experimental research data submitted when the original Chinese patent medicines for external use in Hong Kong and Macao were originally registered in Hong Kong and Macao can be provided as the corresponding application materials
.
(3) Simplify the approval process
.
Approval of listing registration, through the docking of Guangdong, Hong Kong and Macao drug regulatory mechanisms, can reduce the production site inspection and system verification links in the approval process
.
Approval of changes after listing, if the relevant changes are approved in Hong Kong and Macau, you can apply for adjustment of the approval process instead of filing
.
(4) Shorten the approval time
.
The technical review of the listing registration approval was reduced from the original 200 working days to 80 working days, and the total approval time was reduced from the original 235 days to 115 days.
The approval time was reduced by half; the approval and re-registration time limits were changed after the listing.
It also reduced 50 days respectively, further shortening the approval time and speeding up the approval process
.
(5) Optimize examination and approval services
.
Comprehensive policy advisory services have been opened to facilitate Hong Kong and Macao enterprises to familiarize themselves with the Mainland Chinese patent medicine registration management policies and obtain guidance on simplified registration approval policies
.