审评时限由200个工作日压缩至60个工作日

Core Insights - The province has been approved as the 11th nationwide pilot for optimizing the review and approval process of drug supplementary applications, marking it as the only pilot in the second batch and the first in Northeast China, which will significantly boost the local pharmaceutical industry [1] Group 1: Approval and Impact - The approval allows for a substantial reduction in the technical review time for drug supplementary applications from 200 working days to 60 working days, thereby lowering R&D submission costs for enterprises [1] - This initiative is expected to support the collaborative development of the pharmaceutical industry in Northeast China, attracting more pharmaceutical companies, research institutions, and universities to the province [2] Group 2: Implementation Strategy - The provincial drug regulatory department will provide pre-application services based on principles of early intervention, tailored strategies for each enterprise, and comprehensive guidance to improve the success rate of applications [2] - The province aims to create an efficient and accessible drug registration policy environment, which will enhance the overall upgrade of the Northeast pharmaceutical industry [2] Group 3: Promotion and Training - The provincial drug regulatory department will promote and interpret the pilot policy to all drug marketing authorization holders, facilitating a faster application process [3] - Business training will be strengthened to standardize application procedures, aiming for a successful launch of the pilot program [3]