China is an Evolving and Important Market for New Medicines
With 4.3 million new cancer patients in 2015, China has as many cancer patients as the U.S. and EU combined and is the second largest pharmaceutical market in the world by revenue. It’s a dynamic market with expanding reimbursement, increasing patient affordability, regulatory reforms and international quality standards.
Regulatory Reform in China
Recent reforms at the China Drug Administration (CDA) have allowed the country to have an expanding role in the global drug development. One key development is expanding the reimbursement coverage, with oncology drugs now included on the national reimbursement drug list (NRDL), reducing out-of-pocket expenses for patients. Additional provincial-level reimbursement coverage is also expected.
In addition, the CDA joined the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (also known as the International Council for Harmonization or ICH), which includes regulatory authorities and industry organizations from across the globe and sets the standards to elevate drug development practices.
These reforms have removed delays and allowed China to participate in early drug development, and to contribute significantly to global pivotal trials, with international quality standards.