Dive Brief:
- As part of a large-scale reform process, the Chinese Food and Drug Administration (CFDA) said it would accelerate approval of new medications, according to an update published on its website reported by Reuters.
- Although the sheer size and value of the Chinese pharmaceutical market has spurred investment, six-to-eight year approval timelines have been a major challenge for drug makers.
- China is the world's second largest drug market. IMS Health estimates it will be worth $185 billion by 2018, compared to $63 billion last year.
Dive Insight:
The CFDA appears serious about improving quality control and coupling that with expedited approval timelines. China's approval process is notoriously slow, but the agency will now prioritize drugs with clear clinical value, according to Reuters.
The statement said certain drugs will get priority, including drugs for AIDS, cancer, viral hepatitis and rare diseases.
The Chinese State Council in February announced China will undertake consolidation of its pharmaceutical market, aiming to boost the development of its domestic industry. As part of that, the State Council seeks to improve product traceability systems and strengthen overall supervision.
Overall, China hopes to foster domestic innovation to lower China's reliance on foreign drugmakers.