?Revised law to spur China's drug innovation: Symposium
- By Zhang Liying
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E-mail China.org.cn, December 24, 2019
China's revised drug administration law, going into effect on Dec. 1, gives new impetus to the country's pharmaceutical innovation. This was a message of a symposium organized by the Bill & Melinda Gates Foundation on Dec. 18 in Beijing.
Chang Jianqing, vice president of Drug Regulatory Policy with Tigermed, noted that the revised law, adopted by China's top legislature in August, stipulates certain areas in which drug research and development is especially encouraged.
Chang, also deputy secretary of the China Clinical Research Development Foundation, said the revision prioritizes the 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.
"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," she said.
The changes also involve strengthening the capacity building of evaluation and approval authorities, establishing an expert consultation mechanism, enhancing the communication mechanism between drug registration applicants and the authorities, establishing associated evaluation and approval systems, and applying priority or conditional approval to certain drugs, she added.
According to Chang, other measures stipulated in the law for encouraging pharmaceutical innovation include optimizing the administration of drug clinical trials by launching the new filing system for accreditation of the clinical trial institutions.
Chen Bo, Partner at McKinsey & Company, said the revision had been listed by the consulting firm as a major landmark in the development of China's pharmaceutical industry.
The country's ongoing reform of medical products administration since 2015 had achieved remarkable progress, leading to a surge in the number of new drugs launched to the market, Chen noted.
McKinsey's statistics show a total of 16 new drugs received approval to enter the market from 2014 to 2016, with the number reaching 40 in 2017 alone.
On the basis of Clinical Trial Application (CTA) and New Drug Application (NDA) submissions, McKinsey predicted about 150 new medicines would have gained access to the market from 2018 to 2020.
Chen said improvements in regulatory policies further increased China's pharmaceutical innovation capacity. "The country is growing into an innovation powerhouse, rather than just a market. I believe China will deliver more innovative medical products to the world."
Li Yinuo, China director of the Gates Foundation, said supporting medical innovation was high on the agenda. "We support many companies and institutes in developing new medical products, especially those needed for public health and the treatment of communicable diseases."
In addition to the level of products, the foundation also funded innovation in relevant systems and policies, Li pointed out.
China's drug administration law was first promulgated in 1984. The revision in August is the first overhaul since a 2001 revision.
