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© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY By Dr. Frank Gao & Dr. Yajie Li, & Dr. Yuexia Li Regulatory & Access, Parexel International - 8.21.20 -
The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005. SAP is designed to prioritize regulatory resources to help the biopharmaceutical industry develop treatments for combating a public health crisis. Since the COVID-19 pandemic began in early 2020, the Center for Drug Evaluation (CDE) has maximized its capacity and optimized its regulatory procedures within the SAP framework to accelerate COVID-19 related drug development.
When the SAP was established in 2005, NMPA set up the critical rules and timelines to ensure critically important drugs can start clinical trials quickly and get NDA/BLA approval as soon as possible. The key points are:
The below flowchart describes the process for SAP:
Note: all days are calendar days.
In 2020, CDE introduced more flexibility to the original SAP process established in 2005 to maximize the support for the new products to combat the COVID-19 pandemic. The following key points are new additions to the 2005 SAP pathway:
In summary, within the SAP framework, the regulatory pathway for drug development against COVID-19 is straightforward and has the top priority from NMPA and CDE. The prompt and proactive approaches from the Chinese government and regulatory authority has made tremendous differences in the COVID-19 pandemic in China.
How Parexel can help:
Our 1,000+ consultants worldwide, including 80+ former regulators / inspectors / assessors, are optimally positioned to understand just what type of information biopharmaceutical companies need to share with the NMPA for their products and how to effectively collaborate to develop the most effective regulatory and product development strategies for new potential treatments in the combat against COVID-19 and other critical diseases.
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