Five categories and 20 specific measures Heilongjiang determined to support the development of pharmaceutical industry in this way

Source: Heilongjiang Provincial Drug Administration Editor: Dandelion Yuxuan On December 30, 2019, Heilongjiang Drug Administration issued several measures to support the high-quality development of biomedical industry (hereinafter referred to as measures), including five categories and 20 specific measures, including "encouraging technological innovation in research and development, optimizing administrative licensing services, supporting the development of traditional Chinese medicine industry, supporting enterprises to become better and stronger, and standardizing drug market order", aiming at in-depth implementation The Party Central Committee, the State Council and the provincial Party committee and the provincial government made the decision and deployment of the reform of "releasing management service" to promote the high-quality development of the biomedical industry in our province （1） Implement the system of drug marketing license holders We will encourage drug marketing license holders to entrust production, save money and time costs, and stimulate innovation in product research and development Set up consultation service platform and reception day, provide face-to-face technical consultation and policy interpretation for enterprises, and help solve the problems encountered in the process of product development （2） Promote the consistency evaluation of generic drugs Set up a consistency evaluation work promotion group, strengthen technical support, and guide enterprises to accelerate the promotion Open a "green channel" for the one-time import of reference preparations for consistency evaluation We will encourage qualified medical institutions, institutions of higher learning, scientific research institutions and third-party inspection and testing institutions in the province to actively participate in the conformity assessment （3） We will promote the implementation of the registration system for medical devices Taking advantage of the opportunity of our province being listed in the pilot province of medical device registrant by the state, we will support the medical device registrant to entrust qualified manufacturing enterprises to produce products, support the entrusted manufacturing enterprises to submit the registration license held by the registrant to apply for production license, realize the "unbundling" of product registration and production license, encourage the registrant to invest funds in R & D innovation and enjoy policy dividend （4） Support the innovation and development of medical device enterprises For the class II medical devices that are declared to be the first or major technological innovation in China, diagnosed and treated rare diseases, multiple diseases of the elderly, dedicated to children, and urgently needed in clinic, and listed in the major national science and technology projects, key R & D plans or provincial major scientific research projects, priority technology review, priority registration quality management system verification and priority administrative approval shall be implemented （5） Support the development of cosmetics enterprises in the province Encourage the R & D Application of cosmetics with real estate plants and biology as raw materials, adjust and improve the filing work of domestic non special purpose cosmetics, and speed up the turnover and listing of products To support the entrusted cosmetics processing enterprises to invest in the establishment of factories and provide guidance services in policy and technology （6） We will promote the full coverage of the reform of the separation of certificates and licenses We will carry out two ways to comprehensively promote reform, namely, optimizing approval services and informing commitment, further shorten the time limit for approval, reduce application materials, approval processes and approval links, improve simple and transparent industry access rules, and lower the entry threshold for enterprises Upgrade the "promise to change license" to "promise to do license (permit)", and expand the "promise to do license (permit)" to 20 in China (Heilongjiang) pilot free trade zone and Harbin new area （7） Implement "project chief reviewer system" After receiving the registration materials of drugs and medical devices, the provincial food and drug administration shall designate a special person as the chief reviewer of the project to actively communicate with the applicant, answer questions and solve doubts, and provide the whole process of technical guidance services for the enterprise variety registration （8） Implement "service specialist system" When the enterprise handles the approval of administrative license for drugs, medical devices and cosmetics, it can randomly select service specialists to provide the whole process follow-up services such as policy and regulation consultation, on-site guidance, etc （9） Carry out joint inspection and mutual recognition of results For the review and approval items related to the registration, production and operation license of drugs and medical devices, they can be applied for at the same time, inspected jointly and approved in parallel For the administrative examination and approval items requiring on-site inspection, if the enterprise has accepted the inspection of the same content by the State Bureau or the Provincial Bureau within one year, the inspection results shall be mutually recognized and no more repeated inspection shall be carried out （10） Support the inheritance and development of traditional Chinese medicine preparations Establish a filing platform to manage the traditional Chinese medicine preparations with traditional Chinese medicine characteristics and advantages We will support the use of traditional Chinese medicine preparations in medical institutions, and expand the variety and main scope of the use of the preparations Enterprises and scientific research institutions are encouraged to carry out the research on the application for listing of ancient classical Chinese medicine compound preparations （11） Support the clinical research and use of traditional Chinese medicine formula granules Adhere to the principle of combination of inheritance and innovation, encourage enterprises and scientific research institutions to use modern science and technology, carry out clinical research and use of traditional Chinese medicine formula granules, and promote the theoretical practice and innovative development of traditional Chinese medicine （12） Support the development of Chinese herbal pieces We will improve the standard system for local Chinese herbal pieces, and promote the formulation and revision of Heilongjiang province's quality standards for Chinese herbal pieces and the processing standards for Chinese herbal pieces Pharmaceutical manufacturers are allowed to produce and sell Chinese Herbal Pieces in accordance with the provincial standards for processing Chinese herbal pieces On the premise of stable and traceable quality and safety, it is allowed to allow Chinese patent medicine manufacturers and Chinese Herbal Pieces manufacturers to purchase fresh cut Chinese herbal medicines （13） We will promote the use of imported medicinal materials We will implement the measures for the administration of imported medicinal materials (Order No 9 of the State Administration of market supervision), make full use of the geographical advantages of our province, expand the import and utilization of high-quality medicinal materials in Russia, Mongolia and other countries, work with relevant departments to do a good job in the trade and processing industry of medicinal materials, and promote the construction of a large market for the circulation of medicinal materials （14） Support the construction of pharmaceutical industrial park We will support pharmaceutical industrial parks at all levels in the province and China (Heilongjiang) pilot free trade zone to undertake the transfer of high-quality pharmaceutical industry and the transformation of scientific and technological achievements, open up a green channel for the registration and approval of applications for the Clustered Development of biomedical industry, give priority to approval, and provide laws, regulations and technical services （15） Support enterprise merger and reorganization Support pharmaceutical enterprises to optimize their industrial structure through merger and reorganization, enhance their comprehensive strength and core competitiveness, and promote the optimal allocation of resources and industrial transformation and upgrading （16） Encourage the development of modern pharmaceutical logistics Support modern logistics enterprises to participate in drug distribution, support modern logistics enterprises merger and reorganization, integrate the circulation resources, allow the drug manufacturers in the province to set up different places, and support the pharmaceutical industry group in the province to make use of the Internet plus technology to carry out direct drug regulation and multi warehouse coordination, so as to reduce the logistics cost of enterprises （17） Strengthen training and guidance Actively go deep into the production and operation enterprises of drugs, cosmetics and medical devices to carry out on-site guidance, regularly carry out free training for the production and operation quality management personnel and personnel in key positions, improve the quality of employees, and help enterprises improve the quality management level of production and operation.