(Shanghai, China; May 12 2017)
GBI hosted a seminar in Shanghai on the topic of “Industry upgrade: leveraging Big Data for competitive advantage”. Keynote speakers included the former vice-director of the Shanghai Food and Drug Supervision and Administration bureau and current chairman of the Shanghai Food and Drug Safety Research Institute, Tang Minhao, who addressed drug management policy trends affecting pharmaceutical companies in 2017. The topic of rising compliance pressures brought about by the “two-invoice” limitation on pharma sector distribution was addressed by Xu Dong, chairman of China Essential Drugs Co., Ltd, and senior expert at Renmin University’s Medicine and Health Industry Development Research Center. There was also roundtable discussion of the latest health reform implications for multinational and domestic pharma companies by representatives of Amgen, Sanofi, and Innovent Biologics.
Chairman Tang provided an overview of the progress of reforms since the August 2015 release of the State Council’s pivotal No. 44 Opinions paper “On the reform of drug and device reviews and approvals”. Since that notification, Tang illustrated the effectiveness of steps taken by the China Food and Drug Administration (CFDA) to reduce the national backlog of drug filings: during 2016, the Center for Drug Evaluation (CDE) increased its completed reviews quotient by 26% from the previous year, clearing through 12,068 drug filings, while requesting supplementary data in relation to 943 applications. This meant that by September 2016 the filings backlog was effectively resolved, reduced from around 22,000 to close to 8,200.
As underlined by Chairman Tang, a number of key amendments are currently being prepared to the national Drug Administration Law (DAL), which provides the legal foundation for drug management in China. The DAL updates will reflect the CFDA’s shift towards an environment fully conducive to innovative drug development, with implications for both foreign and domestic operators in the market. Key changes on the way include fundamentally redefining the “novel” drug category to refer to a product that has not been approved for market anywhere in the world. Currently, China determines a drug’s novelty based on whether or not it is marketed in China. There is also expected to be provision for conditional drug approvals: allowing new therapies for life-threatening conditions with no current treatment options, breakthrough therapies for major diseases, or orphan disease drugs, the chance to gain conditional market approval based on early clinical trial data demonstrating safety and efficacy.
The meeting closed with presentations from GBI analysts on how Big Data solutions can help pharmaceutical companies compete under the current conditions. In particular, GBI Data Services introduced its latest clinical evidence tracking service, targeted at meeting Chinese physicians and companies’ need for real-world clinical data and academic research tracking. The service is based on machine learning and natural language processing technology, enabling data mining and information extraction, standardization, and translation, as well as relevant analytics and precision push capabilities – well-suited to the growing need for highly specified academic promotion capabilities in the Chinese market.
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Founded in Shanghai in 2002, GBI has built a diverse portfolio of market intelligence solutions for pharmaceutical and device companies and other service providers. Focused on China and the Latin American markets, GBI’s value-added industry information, news, and data services power individuals and organizations’ decision-making and enable more effective communication. As a trusted source of information, GBI has established long-term relationships with both multinational players and local firms, and continues to drive forward the health care industry.
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Yuki Ji – yuki.ji@generalbiologic.com