Regulatory efforts to address the access gap for foreign new drugs in China: the priority review program and related policies

Table 4 Impacts of the PR on the delays among orphan and non-orphan approvals^a.

^aOrphan approvals were defined as the approvals receiving the FDA’s orphan designation. Observations incorporated the post-PR approvals and the pre-PR approvals that were exclusively matched to either the real PR or the real non-PR. Robust standard errors were in parenthesis. Controls included were the FDA’s designations of priority review, accelerated approval, the FDA’s boxed warning at approval, the FDA review extension, the therapeutic areas [cancers, major infectious diseases (HIV/HCV), or others], the type of the pivotal trial enabling the NMPA approval (domestic trial, overseas trial, or global trial with sites in China), the approval class (NDA or BLA), the marketing class (initial marketing approval or new indication supplement), and the year of the NMPA approval. PR, priority review. NMPA, National Medical Product Administration. NDA, new drug application. BLA, biologics license application. *p < 0.10 **p < 0.05 ***p < 0.01.

ISSN: 2397-0642