China is experiencing a surge in activity in pharma clinical trials, becoming an increasingly central part of the pharmaceutical industry. Now the world’s second-largest national pharmaceutical market, China is also pharma’s fastest growing market, with even more significant expansion predicted by 2022.
With greater outsourcing to APAC, and modern technology like EDC and eSource allowing real-time remote data sharing and monitoring, geographic and regulatory barriers are falling. Pharmaceutical organizations around the world have huge opportunities by conducting trials in China. Here’s a closer look at three of those opportunities.
1. Innovation in pharma clinical trials
China is leading research on many promising new drugs, especially in oncology and immunology. In September 2018, China granted landmark full approval to the first drug, a colorectal cancer treatment, produced domestically though modernized clinical trials. Shanghai chemists have recently discovered seven more cancer-fighting compounds that are currently in clinical trials.
These developments are just the beginning: a wave of Chinese innovation is gathering momentum. China’s leading cause of death is cancer, with new diagnoses of the disease expected to reach millions annually. In response, the government has called for national, targeted measures and heavy investment in the development of CAR-T immunotherapy. There are currently more CAR-T clinical trials registered in China than in the U.S.
2. Regulatory reform
The greater potential for developing novel treatments in China is possible due to sweeping reforms. The National Medical Products Administration (NMPA), formally known as the China Food and Drug Administration (CFDA), is unquestionably prioritizing the development of new therapies and has modified regulations to substantially shorten approval timelines in pharma clinical trials, ensure drug quality, and facilitate easier collaboration with international organizations.
The NMPA’s “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” is playing a pivotal role by reducing the drug review process from five years to six months – easing China’s large drug filing backlog of new medications. Over the past three years, they’ve drastically increased their number of reviewers from around one hundred to over a thousand.
On top of this, China recently updated its policy on contract manufacturing organizations to accept overseas clinical trial data. Additionally, the registration requirements for imported drugs have softened. Foreign organizations are now encouraged to conduct global studies in China.
3. Unmet clinical needs
With a growing middle class and aging population, Chinese healthcare demands are rising. By serving unmet treatment needs, new drugs have the potential to make a far-reaching, positive impact in China and worldwide. Estimates suggest lung cancer cases in China will reach one-third of those globally, and therapies that combat this scourge are in especially high demand.
Therefore, outsourcing to China would provide pharma clinical trials with a large pool of potential patients, and there is a need for more capable sites, investigators, and experienced CROs. Technology like eSource can equip these sites with the tools necessary to perform at the highest capacity, as well as to overcome the geographic challenges that long-distance outsourcing poses by enabling real-time remote data sharing.
China offers pharmaceutical researchers more opportunities than ever to stay at the cutting edge and to create breakthrough treatments. Greater international collaboration, combined with new technology and regulatory reform, hold the possibility of surpassing long-standing challenges in pharma clinical trials and creating more critical medical care for millions in need.