On August 5, the Hubei Provincial Food and Drug Administration issued “Several Measures for the Provincial Food and Drug Administration to further exert its regulatory functions and promote the high-quality development of the pharmaceutical industry”. It launched 26 specific measures from eight aspects including supporting drug research and development and innovation, supporting traditional Chinese medicine integrity and innovation, accelerating the review and approval of medical devices, strengthening the construction of public service platforms, and deepening the reform of the review and approval system.
Support drug research and development and innovation. Qualified medical institutions, universities, scientific research institutions and inspection and testing institutions are encouraged to participate in the consistency evaluation work. Fully support the registration applications of innovative drugs, rare disease treatment drugs, children’s drugs, vaccines, blood products, etc. to enter the State Food and Drug Administration’s priority review and approval channel, simultaneously carry out on-site registration verification, GMP compliance inspection, and prioritize inspection and testing. For innovative drug clinical trials to be initiated, a commitment system may be adopted to issue a “Drug Production License” in advance based on registration application requirements.
Support the development of high-end raw materials, new pharmaceutical packaging materials, and pharmaceutical excipients. For manufacturers of innovative APIs and small varieties (drugs in shortage) of APIs, they only need to submit a verification plan or verification plan when applying for a “Drug Production License” to increase their production scope. Support the construction of new pharmaceutical packaging materials and pharmaceutical excipients enterprises, and promote the pharmaceutical industry to replenish and strengthen the chain.
Support the integrity and innovation of traditional Chinese medicine. Improve the construction of local standards for traditional Chinese medicine, promote the construction of “one county, one product” Hubei-produced authentic medicinal material base, and cultivate the “Chu Medicine” brand with independent intellectual property rights. If a traditional Chinese medicine formula granule enterprise in the province has passed the drug GMP compliance inspection when filing for the first time, there will be no need to repeat the inspection when filing subsequent varieties and go through the filing procedures directly. Accelerate the application of traditional techniques to prepare traditional Chinese medicine preparations and the registration of entrusted preparation of traditional Chinese medicine preparations, and encourage medical institutions to choose pharmaceutical manufacturers with high quality management levels for entrusted preparation. Optimize the dispensing and use of traditional Chinese medicine preparations in medical institutions, cancel the technical review process, and directly handle the approval procedures. Traditional Chinese medicine preparations with approval numbers or registration numbers that are urgently needed for clinical use can be dispensed and used within the province with the approval of the Provincial Food and Drug Administration, and the period of dispensed use will be extended to 2 years. Encourage traditional Chinese medicine enterprises in the province to assist and cooperate in jointly establishing a medicinal material resource evaluation and sharing platform and a traditional Chinese medicine exogenous pollutant detection platform to achieve resource sharing and reduce enterprise costs.
Innovative management of traditional Chinese medicine preparations. For traditional Chinese medicine pieces that have little clinical demand, have complicated processing techniques, and whose production costs and ex-factory prices are upside down, commissioned production of traditional Chinese medicine pieces is allowed among Chinese medicine piece manufacturers in the province. Chinese medicine pieces production enterprises in our province are allowed to purchase fresh and cut Chinese medicines produced by processing companies with sound quality management systems. Explore the integrated development of processing and processing at the place of origin, study and formulate a catalog of fresh-cut Chinese medicinal materials and guiding principles for fresh-cut and processed Chinese medicinal materials.
Speed up the review and approval of medical devices. For Class II medical devices that meet the urgent needs of innovation and clinical use and are included in the priority review and approval channel, the technical review time limits for initial registration, changes in licensing matters, and registration renewals are reduced by an average of 50% from the statutory time limits. The time limit for approval of renewal of Class II medical device registration certificates and changes in licensing matters is adjusted to 1 working day. To expedite registration services for Class II medical devices, when applying for registration of Class II medical devices (excluding in vitro diagnostic reagents), you can submit literature data of the same type published in professional journals at or above the provincial level or legally obtained clinical use (test) data as clinical evaluation data. The device registration procedures will be adjusted so that if the same product passes the registration verification and the time does not exceed two years, its related production licensing matters will be exempted from on-site inspection. If the medical device registration change only involves textual changes and no substantive content changes, the technical review process will be cancelled, and the approval process will be processed directly. For domestically registered Class II medical device varieties due to industry transfer to our province, if the product has no substantial changes, complies with current laws, regulations and mandatory standards, has completed process verification and passed the registration inspection, the original registration information can be used when applying for registration, the original review and approval opinions can be adopted, and product registration and production licenses can be approved together. For inter-provincial commissioned production under the registrant system, the verification conclusions of the other province’s systems will be recognized to avoid repeated inspections.
Strengthen the construction of public service platforms. Give full play to the role of the “shop waiter” service team of the Provincial Food and Drug Administration, coordinate the strength of the entire system, and provide enterprises with comprehensive services such as policies and regulations, review and approval, inspection and monitoring, and standard research. Key parks implement priority service mechanisms such as “make appointments, centralized consultation, and special treatment”. To support the development of the cosmetics industry, if there are policy and technical needs for cosmetics manufacturing enterprises, organize personnel to go to the site to provide one-on-one “menu-style” services, and actively explore the co-construction and sharing mechanism of inspection and testing resources in cosmetics parks. Relying on various drug regulatory bureaus, explore the establishment of provincial drug regulatory bureau service platforms in Hubei Free Trade Zone and Comprehensive Bonded Zone. The Wuhan Branch of the Provincial Food and Drug Administration (East Lake Branch) is given the responsibility to carry out approval work in the East Lake High-tech Zone, carry out technical review services, serve enterprises at a distance, and improve service quality and efficiency.
Deepen the reform of the review and approval system. With the goal of “getting one thing done efficiently”, we will deepen the reform of “decentralization, regulation and service”, establish and improve emergency approval and vacancy acceptance procedures, improve priority review and rapid review mechanisms, improve consultation and communication mechanisms, and strive to speed up the administrative approval process by 60%. Enterprises with a drug production license (Category A) will add a Category B classification code, and only review the compliance and completeness of the application materials, and are exempt from on-site inspections. Support various pharmaceutical companies with quality management, risk prevention and control and liability compensation capabilities in applying for drug production licenses (Category B). Traditional Chinese medicine preparations that are prepared according to the theoretical formulations of traditional Chinese medicine and have a history of use in this medical institution for more than 5 years can be exempted from major pharmacodynamics, clinical research and other data, and are conditionally exempted from toxicity test data when applying for preparation registration in medical institutions.
Create a fair and orderly legal environment. Strengthen enterprises’ implementation of product life cycle safety responsibilities. Promote “Internet + supervision”, establish and improve the electronic traceability system for drugs (vaccines), and improve the corporate credit supervision system. Effectively implement the “Guidance on the determination of traditional Chinese medicine pieces that do not meet drug standards and will not affect safety and effectiveness.” Explore an inclusive and prudent regulatory system that is compatible with new products, new business formats, new technologies, and new standards, and create a relaxed innovation environment for industry development while maintaining the bottom line of safety.