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Since the issuance of the "Drug Production License" (B Certificate) in Hainan Province on September 30, 2020, a total of 14 "Drug Production Licenses" (B Certificate) have been issued
.
It is reported that currently 13 drug varieties in Hainan Province have settled in Hainan from other provinces (some companies are going through the procedures for declaration and transfer of document numbers), accounting for one-fifth of Hainan's new drug varieties in 2021
.
According to the industry, these companies will cultivate a new force for the pharmaceutical industry in Hainan and inject new vitality into the development of the pharmaceutical industry
.
It is understood that previously, drug R&D institutions without drug production capacity could not directly obtain drug approval numbers, and drug approval numbers could only be settled in drug manufacturers
.
The B certificate allows R&D institutions to entrust production by enterprises with production conditions and capabilities through entrusted production methods, so as to solve the obstacles to production qualifications for R&D institutions
.
At present, most of the 14 companies in Hainan Province that hold B certificates are drug research and development institutions, some are drug dealers, and some domestic pharmaceutical companies are also contacting and applying for B certificates, and some companies have begun preparations for commissioned production
.
Relevant persons said that most of these drug varieties have good market prospects, and these companies will also cultivate a new force for the Hainan pharmaceutical industry and inject new vitality into the development of the pharmaceutical industry
.
For holders of drug research and development institutions and other holders to apply for a drug production license (B certificate), the notice issued by Hainan Province this year pointed out that priority should be given to the application
.
The notice stated that it encourages the undertaking of the production and transfer of medicines and medical devices
.
The first is to release the dividends of the licensor and registrant system
.
Use relevant preferential policies of the Free Trade Port to actively guide biomedical companies outside the province to land in Hainan through the system of drug marketing license holders and medical device registrants
.
For holders of drug research institutions and other holders to apply for a drug production license (B certificate), priority will be given to the application
.
For cross-provincial entrusted production of medical devices, strengthen cooperation with relevant provincial drug regulatory authorities, explore mutual recognition of cross-provincial registration quality management system verification results, and effectively implement the main responsibility of medical device registrants
.
The relevant person in charge stated that the Type B production license is a new thing, and there are no ready-made and perfect regulations in the existing drug laws and regulations..
The Hainan Provincial Drug Administration is exploring how to access Class B production licenses while exploring how to effectively supervise Class B production license companies, so that they can effectively assume the main responsibility for the entire life cycle of drugs and enable such companies to develop healthily.
.
According to reports, in the supervision and inspection of Class B manufacturing enterprises, the Hainan Provincial Drug Administration urges the enterprises to complete the role change, establish and improve the quality management system covering the entire life cycle of the drug, and have substance for all links of the entrusted manufacturing enterprise.
Supervision, take the responsibility of the change management of the drug after the market, and strengthen the learning and training of relevant laws and regulations
.
Some companies stated that the drug marketing authorization holder system separates the holding of drug approval documents from the production of drugs, and the holders authorize other manufacturers to produce or sell and operate enterprises to sell, and obtain more returns, which is conducive to further stimulation The innovative vitality of drug R&D institutions and scientific researchers encourages drug innovation
.
"We look forward to more companies submitting applications, maximizing the release of policy dividends, attracting more companies to invest in Hainan, blooming a hundred flowers, creating a good business environment for the development of the domestic pharmaceutical industry, and creating a gathering place for the biopharmaceutical industry
.
" The industry said, The overall plan for the construction of the Hainan Free Trade Port proposes to vigorously develop the biomedical industry, and the implementation of the drug marketing license holder system is an important part of promoting the development of the biomedical industry
.
.
It is reported that currently 13 drug varieties in Hainan Province have settled in Hainan from other provinces (some companies are going through the procedures for declaration and transfer of document numbers), accounting for one-fifth of Hainan's new drug varieties in 2021
.
According to the industry, these companies will cultivate a new force for the pharmaceutical industry in Hainan and inject new vitality into the development of the pharmaceutical industry
.
It is understood that previously, drug R&D institutions without drug production capacity could not directly obtain drug approval numbers, and drug approval numbers could only be settled in drug manufacturers
.
The B certificate allows R&D institutions to entrust production by enterprises with production conditions and capabilities through entrusted production methods, so as to solve the obstacles to production qualifications for R&D institutions
.
At present, most of the 14 companies in Hainan Province that hold B certificates are drug research and development institutions, some are drug dealers, and some domestic pharmaceutical companies are also contacting and applying for B certificates, and some companies have begun preparations for commissioned production
.
Relevant persons said that most of these drug varieties have good market prospects, and these companies will also cultivate a new force for the Hainan pharmaceutical industry and inject new vitality into the development of the pharmaceutical industry
.
For holders of drug research and development institutions and other holders to apply for a drug production license (B certificate), the notice issued by Hainan Province this year pointed out that priority should be given to the application
.
The notice stated that it encourages the undertaking of the production and transfer of medicines and medical devices
.
The first is to release the dividends of the licensor and registrant system
.
Use relevant preferential policies of the Free Trade Port to actively guide biomedical companies outside the province to land in Hainan through the system of drug marketing license holders and medical device registrants
.
For holders of drug research institutions and other holders to apply for a drug production license (B certificate), priority will be given to the application
.
For cross-provincial entrusted production of medical devices, strengthen cooperation with relevant provincial drug regulatory authorities, explore mutual recognition of cross-provincial registration quality management system verification results, and effectively implement the main responsibility of medical device registrants
.
The relevant person in charge stated that the Type B production license is a new thing, and there are no ready-made and perfect regulations in the existing drug laws and regulations..
The Hainan Provincial Drug Administration is exploring how to access Class B production licenses while exploring how to effectively supervise Class B production license companies, so that they can effectively assume the main responsibility for the entire life cycle of drugs and enable such companies to develop healthily.
.
According to reports, in the supervision and inspection of Class B manufacturing enterprises, the Hainan Provincial Drug Administration urges the enterprises to complete the role change, establish and improve the quality management system covering the entire life cycle of the drug, and have substance for all links of the entrusted manufacturing enterprise.
Supervision, take the responsibility of the change management of the drug after the market, and strengthen the learning and training of relevant laws and regulations
.
Some companies stated that the drug marketing authorization holder system separates the holding of drug approval documents from the production of drugs, and the holders authorize other manufacturers to produce or sell and operate enterprises to sell, and obtain more returns, which is conducive to further stimulation The innovative vitality of drug R&D institutions and scientific researchers encourages drug innovation
.
"We look forward to more companies submitting applications, maximizing the release of policy dividends, attracting more companies to invest in Hainan, blooming a hundred flowers, creating a good business environment for the development of the domestic pharmaceutical industry, and creating a gathering place for the biopharmaceutical industry
.
" The industry said, The overall plan for the construction of the Hainan Free Trade Port proposes to vigorously develop the biomedical industry, and the implementation of the drug marketing license holder system is an important part of promoting the development of the biomedical industry
.