Hubei Provincial Food and Drug Administration issued a document to promote the high-quality development of the pharmaceutical industry

On August 5, the official website of Hubei Provincial Drug Administration issued a notice on the issuance of the "Several Measures for the Provincial Drug Administration to Further Utilize Regulatory Functions to Promote the High-quality Development of the Pharmaceutical Industry", and introduced 26 measures to promote the high-quality development of the pharmaceutical industry in Hubei Province

The original text is as follows:

Various offices, sub-bureaus, and directly affiliated units of provincial bureaus:

"Several Measures for the Provincial Drug Administration to Further Utilize the Supervision Function to Promote the High-quality Development of the Pharmaceutical Industry" has been reviewed and approved by the party committee of the bureau

Hubei Provincial Drug Administration

August 5, 2021

(Disclosure attributes: disclosed upon application)

Appendix

Several measures for the Provincial Drug Administration to further exert its supervisory functions to promote the high-quality development of the pharmaceutical industry

In order to implement the "Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Building of Drug Regulatory Capability" (Guobanfa [2021] No.

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It is allowed to cut Chinese medicinal materials while the source is fresh
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The province's traditional Chinese medicine decoction pieces production enterprises can purchase freshly cut Chinese medicinal materials produced by processing enterprises in the production area with a sound quality management system
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Combining with the actual situation of the province, explore the integrated development of production area processing and processing, study and formulate the catalog of fresh-cut Chinese medicinal materials and the guiding principles for fresh-cut processing
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Five, speed up the review and approval of medical devices

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Optimize the procedures for handling second-class medical devices
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For the second-class medical devices that meet the urgent needs of innovation and clinical and are included in the priority review and approval channel, the technical review time limit for the first registration, change of licensing items, and renewal of registration is reduced by an average of 50% compared with the legal time limit
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The time limit for review and approval of the renewal of the second category medical device registration certificate and the alteration of licensing items has been adjusted to 1 working day
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Expedite the registration services of the second category of medical devices
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Learn from the experience and practices of other provinces and cities to further release the feasible space for the acceleration and efficiency of the second-class medical device registration and inspection in our province, and effectively improve the sense of acquisition of enterprises
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To apply for the second category of medical device registration (excluding in vitro diagnostic reagents), you can submit literature data published in professional journals above the provincial level or legally obtained clinical use (test) data of the same species as clinical evaluation data
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13.
Optimize medical device registration procedures
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If the registration of the same product is passed and the time is less than two years, the related production license items can be exempted from on-site inspection
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If the medical device registration changes only involve textual changes and no substantive content changes, the technical review process will be cancelled and the approval will be processed directly
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14.
Promote medical device manufacturers outside the province to settle in Hubei
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If the domestic registered second-class medical device varieties are transferred to our province due to the industrial transfer, the products have no substantial changes, comply with the current laws, regulations and mandatory standards, complete the process verification and the registration inspection is qualified, the original registration data can be used when applying for registration, and the original review can be adopted.
Review and approve opinions, and combine approval of product registration and production licenses
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Establish a new mechanism for medical device registration and verification
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Coordinate the supervision and inspection resources of the province’s system, implement the work mechanism organized by the provincial bureau review center and the drug regulatory sub-bureaus for the second category of medical device registration verification, integrate registration verification and supervision and law enforcement inspections, and conduct cross-provincial entrusted production in accordance with the registrant system.
, Recognize the verification conclusions of other provinces' systems and avoid repeated inspections
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6.
Strengthen the construction of public service platforms

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Give full play to the role of the provincial bureau's "dian second" service group
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Coordinating the overall system strength, adopting various methods such as business training, special seminars, on-site guidance, review prompts, review consensus, etc.
, to provide enterprises with a full range of services such as policies and regulations, review and approval, inspection monitoring, and standard research, and guide enterprises in accordance with the law Scientifically and efficiently carry out product R&D registration and production quality management
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17.
Docking the development of service industry clusters
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Actively integrate into the Optics Valley Science and Technology Innovation Corridor strategy, and promote the construction of Hubei's "Big Health Industry Belt"
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In Wuhan National Biological Industry Base, Optics Valley Nanda Health Industry Base, Longyang Lake Health Valley, Yichang Biomedicine Industrial Park and other industrial bases, priority service mechanisms such as "booking appointments, centralized consultations, and special treatments" are implemented to accurately meet the needs of enterprises , Implement "one-to-one" tracking service
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18.
Support the development of cosmetics industrial parks
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Actively support the standardized construction of cosmetic industry parks in various regions, and create a beauty cluster and high-quality development demonstration zone for resource sharing in the cosmetics industry chain
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For cosmetics companies that have policy and technical requirements in terms of functional layout design of production workshops, laboratory construction, and equipment installation, organize personnel to carry out one-to-one "menu->
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Support cosmetics companies to strengthen cooperation with universities and colleges, testing and inspection institutions, strengthen the training of inspectors, and improve inspection and testing capabilities
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Actively explore the joint construction and sharing mechanism of inspection and testing resources in the park
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19.
Establish a service platform for key parks
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Relying on various drug regulatory sub-bureaus, explore the establishment of provincial bureau service platforms in Hubei Free Trade Zone, Comprehensive Bonded Zone and key biomedical industry parks
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The Wuhan Branch of the Provincial Bureau (Donghu Branch) is assigned the responsibility of carrying out examination and approval work in the East Lake High-tech Zone, carrying out technical review services, accepting the business guidance and supervision of the provincial bureau, and serving enterprises with zero distance to improve service quality and efficiency
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Strengthen the construction of medical research platforms
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Taking advantage of the key laboratories of the Provincial Institute for Drug Inspection and the National Bureau of the Provincial Institute for Medical Inspection, carry out basic, critical, forward-looking and strategic regulatory technology research in the fields of blood product quality control, traditional Chinese medicine quality control, and ultrasonic surgical equipment quality evaluation.
Support the application of national and provincial major special projects and scientific and technological innovation projects
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Promote the construction of a technical support service platform
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Actively strive for the implementation of the Central China branch of the National Drug and Medical Device Evaluation Center
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Encourage leading domestic testing technology institutions to set up headquarters or branches in our province
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Support the biomedical companies in the province to divest their superior inspection and testing resources and establish third-party testing technology institutions with independent legal person status
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Deepen the reform of the review and approval system

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Promote process optimization and reengineering
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With the goal of “achieving one thing efficiently”, we will deepen the reform of “delegating management and service”, establish and improve emergency approval and tolerance acceptance procedures, improve the priority review and rapid review mechanism, improve the consultation and communication mechanism, and make every effort to achieve administrative approval The link speed increased by 60%
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23.
Explore innovative working mechanisms
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Companies with drug production licenses (Class A) add Class B classification codes, and only conduct compliance and completeness inspections of the declared materials, and are exempt from on-site inspections
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Support all kinds of pharmaceutical companies with quality management, risk prevention and control and liability compensation capabilities to apply for drug production licenses (Category B)
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TCM preparations formulated in accordance with the theoretical formulas of Chinese medicine and prescriptions with more than 5 years of use history in the medical institution can be exempted from the main pharmacodynamics, clinical research and other materials when applying for the registration of the medical institution preparations, and the toxicity test materials are conditionally exempted
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Create a fair and orderly legal environment

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Compact the main responsibility of the enterprise
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Vigorously carry out publicity and training of the "Three Laws and Two Regulations", strengthen production and operation compliance guidance, improve the quality and safety management level of pharmaceutical production and operation enterprises, and strengthen enterprises to implement product safety responsibilities throughout the life cycle
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25.
Give full play to the effectiveness of credit supervision
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Promote the "Internet + supervision", establish and improve the electronic traceability system of drugs (vaccine), improve the corporate credit supervision system, promote the integrated online and offline supervision, and strengthen the self-discipline and binding force of the industry
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26.
Promote inclusive, prudential and precise supervision
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Optimize the division of powers, reduce repetitive or unnecessary inspection items, and promote the standardization and standardization of supervision and inspection
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Practically implement the "Guiding Opinions on the Confirmation of Safety and Effectiveness of Traditional Chinese Medicine Decoction Pieces Does Not Meet Drug Standards,"
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Explore an inclusive and prudential supervision system that is compatible with new products, new business formats, new technologies, and new models, and create a relaxed innovation environment for industry development on the premise of maintaining a firm bottom line
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