An ambitious slate of reforms proposed by China's State Council could at last relieve the regulatory bottlenecks that have long hobbled development of innovative drugs in and for China by domestic and multinational pharmas alike.
If coupled with pricing and reimbursement reforms proposed earlier this year, the effect on access to innovative medicines would be profound, according to BioCentury's reporting with lawyers and principals at international management consultancies who practice in China, and domestic R&D executives.
However, the regulatory proposals put forth in skeleton form in August must be fleshed out quickly if revisions to the Drug Administration Law, which provides the framework for drug regulation, are to be ratified by the National Congress at its annual session in March.
Innovators will be watching to see whether CFDA embarks on pilots to test the reforms, which the consultants and executives told BioCentury is the most likely next step.
The proposed reforms would build on years of government investment to create an innovative drug industry. VCs report that early results from these investments can be seen in increases in the amount of novel biology being prosecuted in China, and its uptake into domestic start-ups that intend to translate discoveries into innovative drugs.
In particular, the reforms could unleash the growing cohort of forward-thinking domestic pharmas with profitable businesses in generics and traditional Chinese medicines that are now committing significant investment to developing NCEs, including in-licensing China rights to molecules discovered in the West.
These innovators, and multinational pharmas, have been stymied by a well-documented litany of regulatory blockades: far too few and far too inexperienced review staff at CFDA, lengthy review timelines for clinical trials and marketing applications, and an opaque drug review process.
Even with a new and experienced director installed in 2014 and the creation of a new pathway that speeds reviews for domestic companies, the agency has amassed a daunting backlog of applications.
The management consultants and industry executives who spoke to BioCentury place the estimate at 15,000-23,000 NDAs and clinical trial applications (CTAs). They said CTA approvals can take anywhere from