China And Japan Encourage Clinical Research By Streamlining Approval

By Life Science Connect Editorial Staff

Global pharmaceutical and biotech companies are ramping up their clinical research in the Asia-Pacific (APAC) region to increase enrollment and save costs. For example, the APAC CRO market was valued at $7.6 billion in 2021 but is projected to grow to $12 billion by 2025. China and Japan, in particular, have made strides to pivot themselves as global clinical trial leaders.

Experts Sarah Lieber, VP and head of North American regulatory affairs at Sanofi, and Michael Young, principal for biomedwoRx Life Sciences Consulting, spoke with Clinical Leader Live and explained how both countries have streamlined their regulatory processes to accelerate drug development and encourage investment.

China’s Approval Timelines

All clinical research in China must first be approved by the National Medical Products Administration Center for Drug Evaluation (CDE) and the Ministry of Science and Technology, and it must undergo a review by an ethics committee.¹ Just a few years ago, navigating these regulatory bodies entailed a lengthy, painstaking procedure, taking one to four years to complete. However, recent sweeping regulatory reforms have drastically improved the process,² and currently, the CDE takes only 60 days to review an application. As a result of these advancements, China is spearheading global rare disease and cancer research.³

However, companies should be advised that the CDE requires markedly more CMC information than the FDA, similar to EMA requirements. Companies wishing to perform clinical trials in China and seek drug approval must first gather as much CMC data as possible before starting their application. If they are well prepared to present their evidence, companies can maximize this streamlined approval process.

Japan’s Regulatory Reforms

Clinical trials in Japan dipped in the early 2010s due to ethical concerns. As a response, Japan introduced sweeping reforms to clinical research regulations with the 2018 Clinical Trials Act (CTA) and the 2021 Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Combined, these principles improved ethical standards and enacted new data collection requirements.⁴ These reforms also increased regulations for interventional clinical research but paved the way for more observational research. Still, the nation remains underutilized in the clinical trial space and is working to encourage research by streamlining the trial approval process.

The Pharmaceuticals and Medical Devices Agency (PMDA) works with the Ministry of Health, Labour and Welfare to review clinical trial applications. The PDMA provides feedback on companies’ R&D strategies⁵ and responds to applications within 30 days with queries or approval.⁶ According to our panelists, the PDMA is known for being amenable to working with companies to ensure that their applications meet Japan’s high standards. Also, trials must follow the ICH's GCP best practices and Japan's GCPs, which have additional requirements. However, CMC requirements are lighter than in many other countries, making the application process easier for companies.

China And Japan’s Advantages

Gaining clinical trial approval in China or Japan is a complex process involving multiple government agencies. However, both countries offer a large patient population, advanced healthcare infrastructures with a substantial talent pool, and governments actively working to increase drug development in their nations. As the APAC pharmaceutical market continues to expand, and global trials take center stage, both China and Japan are expected to see significant growth in clinical research.