The Bill and Melinda Gates Foundation organized a symposium December 18 in Beijing, China, to discuss pharmaceutical innovation, including the recently revised drug administration law in that country.
Changes to China’s Drug Administration Laws
At the symposium reported on by China.org a few different stakeholders in China’s biopharmaceutical industry were interviewed including Tigermed’s Chang Jianqing, who also happens to be deputy secretary of the China Clinical Research Development Foundation, Chen Bo, a Partner at McKinsey & Company, the prominent consulting firm and Li Yinuo, China director of the Gates Foundation.
Chang conveyed that the new legislation prioritizes clinical value, supporting the development of innovative drugs with clear-cut or special efficacy, pediatric drugs and new treatment for rare or life-threatening diseases China.org noted. Chang quoted, “It also made changes in the evaluation and approval of new drugs. For example, up to 60 working days are specified for the evaluation timeline for clinical trial application.”
Improvements to Reviewers & Authorities
The changes to the law will strengthen the capacity building of evaluation and approval authorities and serve to establish an expert consultation mechanism not to mention tighten up the communication channels between biopharmaceutical company and authorities and introduce evaluation and approval systems which over time will help transform China’s drug development industry. Chang also noted that the new law introduces priority or conditional approval for certain drugs.
Innovation in Drug Development
Interestingly, Chang offered that other stimulated measures are introduced to encourage and bolster pharmaceutical innovation such as the optimization of the clinical trials process via a new filing system for the accreditation of clinical trial institutions. Under the new law according to an assessment by law firm Covington, a notification system for clinical trial site enforces that clinical trials can only be conducted at institutions that have been inspected and accredited by National Medical Products Administration (NMPA) with departments that are certified for that type of clinical investigation. The accreditation process used to require pre-approval but now notification is sufficient.
McKinsey & Company, a prominent global consultancy, supports a considerable operation in China where Chen Bo serves as a Partner. He noted at the symposium that the country’s ongoing reform of medical products administration since 2015 has made remarkable progress. According to McKinsey statistics, a total of 16 new drugs received approval to enter the Chinese market from 2014 to 2016 and that number jumped to 40 in 2017. McKinsey predicted 150 new medicines gaining access to the Chinese market from 2018 to 2020—a huge jump.
Li Yinuo with the Gates Foundation China noted, “We support many companies and institutes in developing new medical products, especially those needed for public health and the treatment of communicable diseases.”
Chang Jianqing, vice president of Drug Regulatory Policy and deputy secretary of China Clinical Research Development Foundation
Chen Bo, Partner McKinsey China
Li Yinuo, China Director, Gates Foundation