Qilu Network Lightning News September 2 news This afternoon, the Information Office of the Shandong Provincial Government held a press conference on the interpretation of the "14th Five-Year Plan for Drug Safety in Shandong Province". At the meeting, Yu Tao, deputy secretary of the party group of the Shandong Provincial Market Supervision and Administration Bureau, secretary of the party group and director of the Provincial Food and Drug Administration, Cao Sen, director of the Registration Office (Administrative Licensing Department) of the Provincial Food and Drug Administration, Wang Xinjian, director of the Drug Production Supervision and Administration Department, Wu Shifu, director of the Medical Device Supervision and Administration Department, and Sun Min, director of the Cosmetics Supervision and Administration Department, interpreted the "14th Five-Year Plan for Drug Safety in Shandong Province" and answered questions from reporters.
In the first half of this year, many new drugs such as Xuan lung septic granules in Shandong were approved for listing. During the "14th Five-Year Plan" period, what are the favorable policies and measures in the review and approval of pharmaceutical medical devices and the promotion of industrial development? "In the first half of this year, we introduced 23 measures to promote the high-quality development of the pharmaceutical industry and 30 measures for the development of traditional Chinese medicine, and 65 new products were approved for listing, ranking second in the country, of which 8 were innovative drugs, improved new drugs, and new Chinese medicine drugs, which were twice the total in the past five years." The first self-produced vaccine in our province was approved for marketing, and the 'Xuan Lung Septic Granules' settled in our province. Cao Sen, director of the Registration Office (Administrative Licensing Department) of the Shandong Provincial Food and Drug Administration, said that during the "14th Five-Year Plan" period, it will adhere to the reform of the drug medical device review and approval system as an important starting point for promoting the high-quality development of the pharmaceutical industry, optimize the review and approval process, encourage drug innovation and research and development, solidly promote the drug registration and licensing work, continuously improve the ability to serve the development of the pharmaceutical industry, and consolidate the industrial foundation of drug safety.
In terms of pharmaceutical and equipment innovation, Shandong will strengthen policy incentives, actively study support policies and work measures, formulate measures to further innovate regulatory services and promote the high-quality development of the pharmaceutical industry, focus on creating a good development environment for drug innovation, and actively create a new highland for the development of the pharmaceutical industry. At the same time, strengthen guidance services, give full play to technical advantages, strengthen the whole process of guidance for major innovative products, special personnel are responsible, rely on services, "one-to-one" guidance to do a good job in drug research and development, inspection and testing, clinical trials, registration declarations, production and listing, etc., to help solve the policy and technical problems encountered in new drug research and development and registration declaration. In terms of coordinating and accelerating the progress of review, the relevant policies of the state to accelerate the listing of drugs will be used well, and the State Food and Drug Administration will be coordinated to include drugs with major innovations that meet clinical urgent needs into the scope of priority review and be subject to conditional approval.
"This year, the two 'global new' innovative drugs approved by our province - tetacilxip for injection and videcetizumab for injection - have been approved for listing after completing the clinical trials of Ι and Phase II., and enterprises can supplement and improve the phase III clinical trial data, which has greatly accelerated the process of product listing." Cao Sen introduced that it will also undertake the technical work related to drug approval, actively strive to undertake the on-site verification of drug approval, and strive for valuable time for the early listing of drugs in the province.
To promote the consistency evaluation of generic drugs, we must earnestly grasp the implementation of measures such as the award and supplement of generic drug consistency evaluation funds and clinical use, encourage and support enterprises to carry out consistency evaluation work; give play to the role of the national drug evaluation center as a contact point for drug innovation and review system reform, strengthen guidance services; meet the needs of drug research and development as the guide, accelerate the improvement of third-party research and development service capabilities, encourage CRO companies with standardized management and outstanding capabilities to give priority to undertaking projects entrusted by enterprises in the province and improve drug research capabilities; Science and technology departments and other departments should study and formulate specific measures to encourage clinicians to carry out clinical trials, and fully mobilize the enthusiasm of clinicians.
The lightning news reporter learned that during the "14th Five-Year Plan" period, Shandong will further promote the implementation of the drug holder system and the medical device registrant system, and further enhance policy support, service capabilities and technical support capabilities. Encourage R&D institutions to apply for registration of new drugs, encourage and support Shandong enterprises to "OEM" the production of drugs, support advantageous enterprises to undertake projects entrusted by holders, increase policy support, and promote major innovative projects to settle in Shandong.
Lightning News reporters Wang Shuwei, Hao Aiyin, and Liu Chen reported