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Recently, the "Regulations of Shanghai Pudong New Area on Promoting the Construction of Zhangjiang Biomedical Industry Innovation Highland" (referred to as the "Regulations") were voted and passed at the 38th meeting of the Standing Committee of the 15th Municipal People's Congress
.
On the whole, the "Regulations" set the main tone for the development of the biopharmaceutical industry and meet the people's new needs for a healthy life
.
There are two meanings in it: one is that innovative medical devices must be able to "save lives"; the other is that they are affordable and affordable for the majority of patients
.
In addition to the above content, it is worth noting that the "Regulations" also specify that a small amount of clinically needed medical equipment will be allowed to be imported, and can be used for specific medical purposes in designated medical institutions in Pudong New Area, so that new overseas drugs can be "expedited" to patients.
.
In this regard, the industry believes that the new regulations will encourage qualified biopharmaceutical companies to conduct applied research on a small number of drugs and medical devices that are urgently needed for clinical import, and may explore the use of relevant data for registration, so as to speed up the process of new drug launches and benefit more.
Many patients
.
In fact, in addition to Shanghai, there are reports showing that the Hainan Provincial Food and Drug Administration has also made new moves in the import of new drugs recently.
It has approved 3 medical institutions in the Boao International Hospital, Boao Super Hospital, and Hainan Provincial People’s Hospital Lecheng District.
Use Encorafenib, Infigratinib, Fortantinib, and Tepotinib, which are not yet registered in China and are in urgent need of clinically imported drugs
.
The analysis believes that the Hainan Provincial Food and Drug Administration once again approved the use of four clinically urgently needed imported drugs in batches because it has been innovating the system and mechanism in many aspects such as drug approval and supervision in recent years
.
In addition, at the end of November, the "Henan Province's Pilot Work Plan for Developing Cross-border E-commerce Retail Imported Drugs" (hereinafter referred to as the "Plan") was officially issued
.
The industry believes that this means that in the future, consumers can order imported drugs online at their doorsteps, which will greatly improve the accessibility and convenience of imported drugs
.
It is worth mentioning that, in order to further reduce the price of cross-border e-commerce retail imported drugs, Henan is also accelerating the construction of the Zhengzhou drug import port function, gradually applying for import registration functions such as medicinal materials and biological products, and promoting the use of international highways, China-Europe trains, etc.
Import medicines by different modes of transportation
.
At present, all localities are making frequent moves in importing new drugs
.
The industry believes that these measures are due to national policies as a whole
.
It is understood that as early as April 12, 2018, the State Council issued the "Opinions on Implementing the Division of Labor of Key Work Departments in the Government Work Report", which clarified: For drugs that have been on the market overseas, study and simplify the approval procedures for import and use
.
On July 10 of the same year, the National Medical Products Administration issued the "Technical Guidelines for Accepting Data from Overseas Clinical Trials of Drugs", clarifying overseas clinical trial data, including but not limited to innovative drugs obtained overseas by applicants through simultaneous domestic and overseas research and development of drugs Clinical trial data.
.
.
On the whole, with the introduction of a series of accelerated approval and review policies for new drugs and medical devices, the pace of importing medical devices has begun to accelerate
.
In the future, under the continuous efforts of national and local policies, the industry expects that a large number of overseas new drugs and medical devices will accelerate into the Chinese market to better meet the needs of domestic patients
.
.
On the whole, the "Regulations" set the main tone for the development of the biopharmaceutical industry and meet the people's new needs for a healthy life
.
There are two meanings in it: one is that innovative medical devices must be able to "save lives"; the other is that they are affordable and affordable for the majority of patients
.
In addition to the above content, it is worth noting that the "Regulations" also specify that a small amount of clinically needed medical equipment will be allowed to be imported, and can be used for specific medical purposes in designated medical institutions in Pudong New Area, so that new overseas drugs can be "expedited" to patients.
.
In this regard, the industry believes that the new regulations will encourage qualified biopharmaceutical companies to conduct applied research on a small number of drugs and medical devices that are urgently needed for clinical import, and may explore the use of relevant data for registration, so as to speed up the process of new drug launches and benefit more.
Many patients
.
In fact, in addition to Shanghai, there are reports showing that the Hainan Provincial Food and Drug Administration has also made new moves in the import of new drugs recently.
It has approved 3 medical institutions in the Boao International Hospital, Boao Super Hospital, and Hainan Provincial People’s Hospital Lecheng District.
Use Encorafenib, Infigratinib, Fortantinib, and Tepotinib, which are not yet registered in China and are in urgent need of clinically imported drugs
.
The analysis believes that the Hainan Provincial Food and Drug Administration once again approved the use of four clinically urgently needed imported drugs in batches because it has been innovating the system and mechanism in many aspects such as drug approval and supervision in recent years
.
In addition, at the end of November, the "Henan Province's Pilot Work Plan for Developing Cross-border E-commerce Retail Imported Drugs" (hereinafter referred to as the "Plan") was officially issued
.
The industry believes that this means that in the future, consumers can order imported drugs online at their doorsteps, which will greatly improve the accessibility and convenience of imported drugs
.
It is worth mentioning that, in order to further reduce the price of cross-border e-commerce retail imported drugs, Henan is also accelerating the construction of the Zhengzhou drug import port function, gradually applying for import registration functions such as medicinal materials and biological products, and promoting the use of international highways, China-Europe trains, etc.
Import medicines by different modes of transportation
.
At present, all localities are making frequent moves in importing new drugs
.
The industry believes that these measures are due to national policies as a whole
.
It is understood that as early as April 12, 2018, the State Council issued the "Opinions on Implementing the Division of Labor of Key Work Departments in the Government Work Report", which clarified: For drugs that have been on the market overseas, study and simplify the approval procedures for import and use
.
On July 10 of the same year, the National Medical Products Administration issued the "Technical Guidelines for Accepting Data from Overseas Clinical Trials of Drugs", clarifying overseas clinical trial data, including but not limited to innovative drugs obtained overseas by applicants through simultaneous domestic and overseas research and development of drugs Clinical trial data.
.
.
On the whole, with the introduction of a series of accelerated approval and review policies for new drugs and medical devices, the pace of importing medical devices has begun to accelerate
.
In the future, under the continuous efforts of national and local policies, the industry expects that a large number of overseas new drugs and medical devices will accelerate into the Chinese market to better meet the needs of domestic patients
.
