The pharmaceutical market in China has evolved significantly over the past five years, explained Paul Bridges, corporate vice president and worldwide head of consulting, Parexel.
These changes in the country’s regulatory process were intended to close “the gap between China and other countries in drug development,” Bridges told us.
The Chinese Premier Li Keqiang announced several developments during an executive meeting of the State Council of the People's Republic of China earlier this year.
Among these changes, the National Medical Products Administration (NMPA) – the recently renamed China Food and Drug Administration (CFDA) – has reduced approval timelines dramatically.
The agency also now accepts foreign clinical trial data if there are no significant ethnic differences in the patient population, Bridges explained. The guideline was issued in October of this year.
Additionally, in 2017 China joined the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The move helps ensure that pharmaceutical manufacturers and developers “will be held to the same standards as other markets,” said Bridges.
Market access also is expanding “rapidly,” he said, in response to rising incomes, expanding reimbursement by public and private insurance, and a growing health care infrastructure.
“An influx of capital to the biotechnology industry in China has also occurred in recent years. All of these changes present great opportunity for today’s biopharmaceutical companies,” said Bridges.
“China will form a more integral role in global drug development, allowing countries to access this high growth market as part of a fully integrated global development plan.”
The country’s regulatory evolution is a win for both the industry and patients. As Bridges explained, increased market access will enable companies to develop more robust, harmonized, and de-risked global drug development programs, “ultimately advancing the development of and access to important new therapies.”
In addition to changing government policy and greater capital investment, drug innovation in China is increasing due to unmet medical needs, the expanding middle class, and a “stronger belief in innovation economics,” explained Bridges.
According to a report by the Economist Intelligence Unit (EIU), the industry could decrease patient recruitment timelines, increase the likelihood of launch, and help ensure inclusion on payer formularies through several avenues.
These include adopting patient-centric practices, using real world data, advancing precision medicine, and implementing adaptive trials.
Bridges said, “The use of these innovations in China was significantly behind the US and the EU, which contributed collectively two-thirds of the trials leveraging these innovations.”
Today, the Chinese pharmaceutical market has outpaced Japan to become the second largest market globally.
