Recently, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices” (hereinafter referred to as the “Opinions”). Following the August 2015 “Opinions of the State Council on Reforming the Review and Approval System for Pharmaceuticals and Medical Devices,” this document represents another landmark policy paper aimed at further advancing the reform of the review and approval system for pharmaceuticals and medical devices. It can be seen as a comprehensive summary and deepening of the two-year experience gained in this reform, as well as a concentrated embodiment of the strategic decisions and arrangements made by the CPC Central Committee and the State Council regarding the regulation of food and drugs.

　　To gain a deeper understanding of the new policies and closely track their evolving implications in order to adjust industry strategies, the 29th National Pharmaceutical Economic Information Conference—sponsored by the Southern Institute of Pharmaceutical Economics under the State Food and Drug Administration, organized by the Pharmaceutical Economic Daily, and hosted by Biaodian Information Group—will be held in Changzhou, Jiangsu, from November 7 to 10. This year’s theme is “Resonant Industrial Support for Upward Momentum: The Resilience and Tension of China’s Pharmaceutical Economy.” The conference will implement the spirit of the 19th National Congress of the Communist Party of China, with a focus on interpreting the key policy points of the relevant Opinions, conducting policy discussions, and presenting five-year mid-term forecasts for domestic and international pharmaceutical markets and R&D trends. During the event, the Southern Institute and MeneNet will release more than ten cutting-edge and high‑profile research reports on the pharmaceutical industry. Meanwhile, the Pharmaceutical Economic Daily, drawing on over one hundred expert judges from industry, academia, media, professional associations, and third‑party research institutions, will launch its highly anticipated “2017 China Pharmaceutical Economy Person of the Year” selection, with the results to be officially announced at this conference.

　　In terms of policy analysis, the key topics include the direction of China’s economic reforms following the 19th National Congress, recent developments in the drug review and approval system, new trends in pharmaceutical regulatory policies and laws, emerging dynamics in the medical insurance payment reform, and the latest progress in healthcare reform. As one of the main segments of the information briefing, this year’s data releases will cover the 2018 pharmaceutical industry forecast and a five-year outlook, an analysis of the characteristics and future development trends of the three major terminals and six major markets, market characteristics and trends for leading traditional Chinese medicine products, market features and trends for products listed under the consistency evaluation program, as well as the characteristics and trends of pharmaceutical industrial parks.

　　In fact, as pharmaceutical reform accelerates and the pace of policy implementation across regions quickens, the pharmaceutical sector has already undergone significant changes. At a recent press conference, a spokesperson from the National Medical Products Administration stated unequivocally: “Reform has expanded beyond the review and approval process to encompass a comprehensive overhaul of the regulatory system, achieving full‑life‑cycle management of drugs and medical devices. Regulatory innovation now extends to every stage—research and development, manufacturing, distribution, and use—aiming to harness regulatory breakthroughs to spur industry‑wide innovation.”

　　Since the 18th National Congress of the Communist Party of China, the policy and institutional environment for pharmaceutical innovation has undergone significant changes. In recent years, an increasing number of pharmaceutical researchers with overseas experience have returned to China to conduct research and start businesses, while domestic pharmaceutical companies have seen a steady rise in the number of new‑drug applications and approvals. The reform of the drug and medical device review and approval system, launched in 2015, has raised the quality standards for evaluations, curbed the practice of falsifying clinical trial data, enhanced transparency in the review and approval process, and granted priority market access to a number of innovative drugs and medical devices, gradually establishing a review and approval framework aligned with international norms. In February 2016, the General Office of the State Council issued a document clarifying policies related to bioequivalence evaluation, and several local governments subsequently introduced supporting measures. Companies have demonstrated strong enthusiasm for participating in bioequivalence assessments. In November 2015, the National People’s Congress authorized pilot programs for the marketing authorization holder system in ten provinces and municipalities, which has boosted researchers’ innovation drive; many localities have called for the nationwide implementation of this system.

　　In response to the salient challenges currently facing innovation in pharmaceuticals and medical devices, the Opinions propose reforms to clinical trial management, expedite marketing authorization reviews and approvals, and promote both innovative products and the development of generic drugs. Addressing the shortage of clinical research resources, the Opinions stipulate that the qualification accreditation of clinical trial institutions will be transitioned to a filing‑based management system. They also call for accelerating the review and approval of urgently needed medicines and medical devices, allowing conditional marketing authorization where appropriate, with follow-up studies conducted as required after market launch. In addition, the Opinions outline a series of coordinated reform measures, including the establishment of a system linking drug review and approval with patent protection, a patent term extension mechanism, and a clinical data protection regime.

　　As a pharmaceutical industry and as pharmaceutical enterprises, how should we grasp the spirit and essence of the “Opinions,” accurately understand the key policy points, and effectively leverage these policies to drive our own development? The relevant interpretations presented at this year’s press conference will provide you with valuable insights.