China’s Regulatory Reform and its Contribution to Global Pharmaceutical Innovation

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Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) highlights the leaps and bounds with which the Chinese pharmaceutical industry has developed in recent years, the country’s increasingly important role in the global innovation landscape, and why cross-border collaboration is more crucial than ever in the time of COVID-19.

 

In today’s globalized world, no single country can stand alone

 

In recent years, with the unfolding of reforms within the pharmaceutical regulatory landscape and the establishment of a more open and inclusive capital markets structure, China has been working to improve its policy environment in order to encourage pharmaceutical innovation. Accordingly, the Chinese pharmaceutical industry has advanced in leaps and bounds. In 2008, the establishment of the National Science and Technology Major Project attracted a significant wave of overseas Chinese scientists and researchers to return to China to set up their own companies, advancing the cause of domestic pharmaceutical innovation.

 

In 2015, the Chinese regulatory regime began to undergo reforms in earnest, most notably with the publication of a number of notices from the country’s top leadership bodies, including the unveiling of the ‘Opinions on the Reform of the Review & Approval System for Drugs and Medical Devices by the State Council’, the General Office of the CPC Central Committee’s and the General Office of the State Council’s ‘Opinions on Deepening the Reform of the Review and Approval Systems and Encouraging Innovation on Drugs and Medical Devices’ as well as the updated ‘Drug Administration Law’. These promulgated a series of policies intended to foster pharmaceutical innovation as well as strengthen intellectual property (IP) protection, accelerating the pace of new drug development and translational science.

 

As the reforms have advanced, the regulatory hurdles impeding innovation have been steadily eliminated. As one indication, the number of clinical trial applications in China has increased significantly from year to year.

 

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As the globalization of drug R&D continues, China has also become a priority destination for global multi-regional clinical trials. Thus, we can see a similar upward trend in the application and approval numbers of global multi-regional clinical trials involving China.

 

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At the same time, the number of clinical trial centers and institutions in China has grown accordingly. In April 2016, there were only 478 clinical trial centers in China. By 2019, there were 886 registered clinical trial institutions, an increase of 185 percent. With the implementation of the record-filing system for the registration and management of clinical trial institutions in China in November 2019, more and more medical institutions will be qualified to run clinical trials. This will enable China to address the growing numbers of clinical trials taking place in China as well as support the development of innovative drugs.

 

In 2017, the Chinese regulator, the National Medical Products Administration (NMPA), officially joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), highlighting the convergence of the Chinese regulatory system with international norms. As the second-largest economy in the world, China is a staunch supporter and defender of economic globalization. In the same vein, achieving mutual recognition of clinical trials data from China and global is the only way for Chinese pharmaceutical innovation to go global. On 30 March 2020, the new ‘Provisions for the Drug Registration’ published by the NMPA clearly stipulates that NMPA will now accept global clinical trial data in NDA filings for the China market. Before 2015, there was a gap of between five to seven years between new drug approvals in the US versus in China. Following the aforementioned Chinese pharmaceutical reforms, this time lag has been reduced to one or two years, and in some cases, even a few months. As a result, the numbers of NDA approvals and launches have increased noticeably.

 

In 2016, only six imported drugs were approved for the Chinese market. Between 2017 and 2019, an average of 40 new imported drugs were launched on the Chinese market each year, over six times the 2016 number! It is clear that more and more global innovative drugs are now able to enter the Chinese market, offering more options to patients in China and allowing them to access and benefit from new therapies at the same time as patients globally.

 

In this process of internationalization, China’s domestic innovation capabilities and achievements are gradually emerging. In December 2018, the biotech FibroGen’s internally-developed first-in-class drug roxadustat became the first innovative drug to be launched first in China before other markets globally. In November 2019, the NMPA gave a conditional approval to sodium oligomannate, a therapy for Alzheimer’s disease developed by the Shanghai Institute of Materia Medica (Chinese Academy of Sciences), which has the potential to fill the global gap in this therapeutic area. Also in November 2019, BeiGene’s internally-developed cancer drug, zanubrutinib, received accelerated approved by the US FDA, becoming the first Chinese-developed anticancer drug to be approved through one of their four expedited approaches for serious diseases.

 

At the same time, many Chinese companies are expanding their global presence, including companies like Innovent Biologics, BeiGene, Jiangsu Hengrui, Hutchison MediPharma, Ascentage Pharma – to name just a few outstanding enterprises – who have begun working on global clinical trials. Through this progress, China is now becoming a contributor and provider of value to the global innovation ecosystem. In 2018, McKinsey added China to the list of second-tier innovator countries, alongside the innovative markets of Europe and Japan, reflecting the tremendous progress made in Chinese pharmaceutical innovation. China has now advanced from being a global innovation ‘follower’ to a ‘parallel runner’ – with the ultimate ambition of becoming a global innovation ‘leader’.

 

Presently, the new coronavirus, COVID-19, raging across the world, has severely impacted the global socioeconomic situation. As the country first hit by the COVID-19 pandemic, China has embarked on an active program to research and develop new treatments for this disease, working with domestic and international pharma companies to conduct clinical trials, while simultaneously extending a helping hand towards the 120 countries globally as well as the World Health Organization, African Union and other international institutions through the provision of medical supplies and interventions.

 

On 26 March 2020, Chinese President Xi Jinping announced at the G20 Summit: “This is a virus that respects no borders. All must work together to build a strongest global network of control and treatment that the world has ever seen. It is imperative that countries pool their strengths and speed up research and development of drugs, vaccines and testing capabilities in the hope to achieve early breakthrough to the benefit of all.”

 

This unprecedented coronavirus pandemic demonstrates the interconnectivity and fragility of the global economy. In today’s globalized world, no single country can stand alone. The pandemic has made clear that the advancement of innovative biomedical technology is inextricably intertwined with human health. The only way to safeguard the progress of humanity and to protect the citizens of our global village is for the global pharmaceutical and healthcare sectors to come together and collaborate in an open manner in the pursuit of innovation.

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