Guizhou's measures to promote the high-quality development of the pharmaceutical industry

Medical Network, August 18 News On August 13, Guizhou Provincial Food and Drug Administration issued a notice on "Several Measures to Promote the High-Quality Development of the Pharmaceutical Industry"
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The original text is as follows:
Municipal (prefecture) market supervision bureaus: In order to conscientiously implement the decisions and deployments of the Party Central Committee, the State Council, the Provincial Party Committee and the Provincial Government and the State Food and Drug Administration on deepening the reform of “delegation, regulation and service” and promoting the high-quality development of the pharmaceutical industry, and promote the inheritance of traditional Chinese medicine Innovative development, to promote the implementation of industrial doubling in our province and strive to achieve industrial breakthroughs.
The Provincial Bureau has formulated the "Measures to Promote the High-Quality Development of the Pharmaceutical Industry", which is hereby issued to you.
Please implement it in accordance with the actual situation
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Guizhou Provincial Drug Administration August 10, 2021 (this document is actively disclosed)
Several measures
to promote high-quality development of the pharmaceutical industry "Government and service" reform and decision-making deployment to promote the high-quality development of the pharmaceutical industry, promote the inheritance and innovative development of traditional Chinese medicine, promote the implementation of industrial multiplication actions in our province, and strive to achieve industrial breakthroughs.
Combining actual work, the following work measures are proposed
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1.
The guiding ideology
is guided by Xi Jinping’s thoughts on socialism with Chinese characteristics in the new era, with the “four strictest” as the fundamental follow, fully implement the spirit of General Secretary Jinping’s inspection of Guizhou’s important speech, and thoroughly study and implement the 19th National Congress of the Communist Party of China and the 19th National Congress of the Communist Party of China The spirit of the Second, Third, Fourth and Fifth Plenary Sessions of the 12th Provincial Party Committee and the Eighth and Ninth Plenary Sessions of the Twelfth Provincial Party Committee, focusing on the main objectives of the “Four New” and the “Four Modernizations” to further deepen the review of pharmaceuticals and medical devices Reform of the examination and approval system will continue to promote the modernization of the drug regulatory system and regulatory capabilities, promote the implementation of industrial multiplication actions in our province, strive to achieve industrial breakthroughs, promote the inheritance and innovative development of traditional Chinese medicine, and promote the high-quality development of the pharmaceutical industry
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2.

Strict development goals for medicines and cosmeticsAnd medical devices are supervised by the entire subject, variety, and chain, and resolutely maintain the bottom line of drug safety
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Efforts will be made to deepen the reform of "decentralization, management and service" to optimize the business environment
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Strengthen the protection of intellectual property rights, support enterprise patent applications, the transformation and application of invention and creation achievements, and promote enterprise innovation and development
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Insist on combining supervision with service, attach equal importance to quality and efficiency, and use more practical measures to further promote the implementation of industrial multiplication actions in our province, strive to achieve industrial breakthroughs, promote the inheritance and innovative development of traditional Chinese medicine, and promote the high-quality development of the pharmaceutical industry
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3.
Main measures
　　(1) Encourage integrity and innovation
1.
Improve the quality standards of Chinese medicinal materials and Chinese medicinal pieces
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Promote the formulation and revision of the quality standards for traditional Chinese medicinal materials and national medicinal pieces of Chinese medicine in Guizhou Province, and incorporate the special processing methods of Chinese medicinal varieties such as dendrobium and prickly pear into local standards to promote the development of traditional Chinese medicine inheritance and innovation
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2.
Encourage the research and development of ancient classic Chinese medicine compound preparations
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Guide enterprises to carry out the research and development of ancient classic Chinese medicine compound preparations in accordance with relevant policies and technical requirements of the State Drug Administration, and encourage the use of new technologies and new methods to optimize production processes and improve the quality of preparations research and development
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3.
Support the innovation and development of traditional Chinese medicine and biological products
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Support enterprises to carry out the secondary development and quality standard improvement of superior varieties of traditional Chinese medicine and national medicine, strengthen policy guidance and technical support; encourage enterprises to develop biological product research and development, support enterprise technological innovation, accelerate the application of new technologies, and promote the innovative development of the biomedical industry
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4.
Standardize the registration and management of traditional Chinese medicine preparations in medical institutions
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Formulate the implementation rules for the registration and management of medical institutions in Guizhou Province, improve and improve the registration system of traditional Chinese medicine preparations in medical institutions, strengthen the supervision and management of preparations registration in medical institutions, and promote the development of the preparation industry of medical institutions
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5.
Encourage medical devicesInnovation and development
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Encourage enterprises to carry out the research and development application of innovative medical devices in accordance with the "Special Approval Procedures for Innovative Medical Devices in Guizhou Province (Trial)", assign special personnel to carry out special guidance, shorten the initial review time limit, and cooperate with enterprises to register and declare with the State Food and Drug Administration
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　　(2) Support the development of the industry
6.
Promote the development of the Chinese herbal medicine industry
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Organize the formulation of a catalogue of Chinese medicinal materials processing (prepared freshly cut) in Guizhou Province and processing guidelines, and allow Chinese medicinal pieces manufacturers to purchase Chinese medicinal materials that meet the standards for processing at the place of production (cut freshly prepared), and support Chinese medicinal pieces manufacturers in the place of production.
Increase production address
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7.
Promote the development of the traditional Chinese medicine formula granule industry
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Encourage enterprises to improve the standard of Chinese medicine formula granules, organize the formulation of quality standards for Chinese medicine formula granules in Guizhou Province, formulate rules for the management of Chinese medicine formula granules in conjunction with industrial policies, and support the healthy development of the Chinese medicine formula granules industry
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8.
Support the development and growth of production enterprises
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Support drug manufacturers to adopt mergers, reorganizations, alliances, etc.
to integrate their stock assets, and if they meet the requirements of industrial development policies and relevant laws and regulations, the "Drug Production License" will be issued or changed
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9.
Support enterprises to accelerate the implementation of pharmaceutical GMP transformation
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Strengthen technical guidance and regulatory consulting services, accelerate the progress of drug GMP compliance inspection, encourage and guide drug manufacturers to accelerate the implementation of drug GMP transformation, and promote the upgrading of the pharmaceutical industry
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10.
Support enterprises to accelerate the compliance construction of medical device production
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Encourage companies to implement compliance reforms, guide and help companies to carry out production activities in accordance with regulatory requirements, and support the development of medical device companies
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11.
Encourage the development of modern pharmaceutical logistics
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Implement the extended demonstration project of pharmaceutical logistics services, encourage the standardization and socialization of logistics functions of pharmaceutical distribution companies, and support third-party pharmaceutical modern logistics companies to extend modern pharmaceutical logistics services to manufacturing companies and medical institutions
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　　(3) Strengthen technical support
12.
Strengthen the construction of inspection and testing capabilities
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Strengthen the capacity building of provincial-level drug and medical device inspection and testing institutions, improve the efficiency of inspection and testing, and provide powerful inspection and testing technical services for drug and medical device innovation, research and development, and emergency protection
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13.
Carry out laboratory comparison work
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Organize drug and medical device inspection and testing institutions and manufacturing enterprise laboratories to carry out inspection and testing comparisons, verify the reasonable use of laboratory equipment and facilities, ensure that the inspection and testing data are true and effective, and improve the testing and operating skills of the inspectors
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14.
Promote the innovation of medical device technology services
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Supporting the cooperation between medical device inspection and testing institutions and third-party inspection and testing institutions, assisting medical device enterprises in product innovation and R&D, and promoting the development of the medical device industry
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15.
Establish a sound pharmacovigilance system
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Supervise and urge enterprises to establish a sound pharmacovigilance system, strengthen drug safety risk management, and provide technical support for enterprises to carry out drug safety risk control; improve the establishment of a monitoring and evaluation system for adverse drug reactions in medical institutions
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16.
Promote the construction of a team of professional inspectors
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Study and formulate plans for the construction of a professional inspector team, adjust and enrich the inspector team through multiple channels, improve the talent structure of inspectors, strengthen the management of the inspector team, combine theoretical study with work training, and continuously improve the professional quality and work ability of inspectors
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　　(4) Optimized review and approval
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Optimized technical review
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In-depth advancement of administrative licensing "provincial administration, one-time operation", domestic drug re-registration, and licensed pharmacist "inter-provincial administration"; strengthen technical guidance and services, optimize technical review procedures, implement combined inspections, and improve review efficiency
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18.
Support the establishment of high-quality medical equipment products in Guizhou
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For the second-class medical device products that have been approved for registration or have obtained the import medical device registration certificate in other provinces and cities, if they meet the production conditions and product safety bottom line requirements, the review and approval process can be simplified
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19.
Support the use of preparations in medical institutions
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The preparations of traditional Chinese medicine ethnic medicine medical institutions for external use can be transferred to medical institutions in the province; other traditional Chinese medicine ethnic medicine medical institutions preparations that are not used can be adjusted step by step to the second-level or above Chinese medicine hospitals in our province and have traditional Chinese medicine on the basis of pilot use.
For use by hospitals above the department; the preparations of counterpart assistance hospitals can be transferred to the recipient hospital during the period of counterpart assistance; the preparations of medical institutions between the compact medical consortium and affiliated hospitals of the same medical school can be adjusted for use; The use period of preparations in medical institutions has been adjusted from 6 months to 12 months
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　　(5) Standardize the market order
20.
Implement the strictest supervision
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Strictly implement the "four most stringent" requirements, intensify the supervision of drugs, cosmetics and medical devices, severely crack down on illegal activities such as the manufacture and sale of counterfeit and shoddy products, and create a strong industry with strong supervision and promote the high-quality development of the pharmaceutical industry
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21.
Establish a sound security risk prevention and control system
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Establish a risk consultation system, organize regular risk consultation meetings, formulate guidelines for the construction of a drug safety risk prevention and control system, comprehensively investigate hidden risks, and further prevent and resolve the quality and safety risks of drugs, cosmetics and medical devices
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22.
Increase the intensity of random inspections
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Scientifically formulate and implement annual sampling inspection plans for drugs, cosmetics and medical devices, complete sampling tasks in an all-round way, strengthen special sampling inspections, actively promote risk monitoring and exploratory inspections, and publish inspection and testing results in a timely manner in accordance with the law
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23.
Promote the construction of "data center"
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Relying on the Guizhou Drug Administration's comprehensive supervision platform, build an online data center for drug supervision across the province, realize unified management of data, and gradually realize "one product, one file" and "one company, one file"; promote the construction of drug traceability monitoring subsystems, and carry out production and storage The collection of retrospective data in the links of, distribution, etc.
, early warning, analysis, and research and judgment of abnormal drug circulation, and effectively guarantees the safety of people's medical equipment
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　　4.
Organize and guarantee the
establishment of a leading group of the Provincial Drug Administration to promote the high-quality development of the pharmaceutical industry.
The chief leader of the bureau will serve as the team leader, the in-charge leader will serve as the deputy team leader.

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All responsible units must establish an overall concept, according to the division of responsibilities, focus on main responsibilities, strengthen coordination and cooperation, do a good job implementation, coordinate the implementation of the industrial multiplication action, strive to achieve industrial breakthroughs, promote the inheritance and innovation of traditional Chinese medicine, and promote the high-quality development of the pharmaceutical industry.

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