The China Food and Drug Administration (CFDA) recently revealed its 2015 key regulatory reform initiatives in the area of drug review and approval. The overall objectives of these initiatives are to encourage innovation and improve the special review and approval procedures; rigorously regulate the review and approval of generic drugs to control low-quality generic drug applications; and reduce the drug review backlog to achieve the goal of meeting the statutory review timeline by 2018.
CFDA has submitted the proposal to the State Council for approval. The proposed policy changes include: establishing a Marketing Authorization Holder system for innovative drugs and a special review mechanism for innovative drugs; changing the review strategy for generic drugs; eliminating separate review for pharmaceutical excipients and packaging materials; and adjusting application fee schedules.
Several possible changes are of particular importance to life sciences and pharmaceutical companies. Eligibility for special review (so-called “Green Channel” or accelerated review) may be expanded to include imported innovative drugs if manufacturing is transferred to domestic production, pediatric drugs, and innovative products with new and advanced formulation technology or significant therapeutic benefits. In addition, the Chinese Center for Drug Evaluation may strengthen the criteria for application acceptance and gradually require universal use of the Common Technical Document in applications. On-site inspections of manufacturing facilities and clinical trials are also likely to increase.
Specific measures will be announced and implemented throughout 2015. Life sciences companies should closely monitor CFDA’s policy and procedure changes and update their regulatory plans accordingly.