XINHUA PHARM(SZ:000756) Qi Lu Wan Bao·2026-01-16 10:18Core Viewpoint - The Shandong Provincial Government is implementing comprehensive reforms in drug and medical device regulation to promote high-quality development in the pharmaceutical industry while ensuring public health and safety [1][3]. Group 1: Safety Assurance - The focus is on maintaining safety standards while promoting development, establishing a three-tier responsibility system involving local authorities, departments, and enterprises [4]. - Shandong has introduced a party document that mandates joint responsibility for drug safety at the party and government levels, setting a benchmark for national pharmaceutical enterprises [4]. - The drug inspection pass rate in Shandong is over 99.8%, exceeding the national average, reflecting the effectiveness of safety measures [4]. Group 2: Reform Empowerment - Shandong has been included in the National Medical Products Administration's service range for drug and medical device review, becoming the only province outside the Beijing-Tianjin-Hebei region to do so [5]. - The province has been approved as a pilot for optimizing drug supplementary application review processes, reducing review times by 70% and ranking among the top in the country for processing volume [5]. - Establishment of review and inspection sub-centers in Jinan, Yantai, and Heze has led to an average processing time reduction of over 50%, with some matters being processed on the same day [5]. Group 3: Enterprise Support - A comprehensive policy support system covering the entire lifecycle of drug development, registration, production, and use has been established [5]. - The approach has shifted from "enterprises seeking help" to "regulatory agencies providing support," enhancing the efficiency of the approval process [5]. - Since the beginning of the 14th Five-Year Plan, Shandong has seen the launch of 1,096 new drug products, with an annual growth rate exceeding 30% [5].