BY DR. FRANK GAO, DR. YAJIE LI, & DR. YUEXIA LI - REGULATORY & ACCESS CONSULTING, PAREXEL INTERNATIONAL
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:
- Before IND, the sponsor is required to communicate with CDE and work together to assess the potential of new drugs for prevention and/or treatment of the pandemic disease. The response timeline for CDE is 24 hours.
- At IND stage, a special advisory committee reviews and decides whether the application fits the criteria of SAP, also within 24 hours.
- Once SAP designation is granted, technical review should be started within 24 hours and the first round of review should be completed within 15 days.
- If the sponsor is required to submit more information or data, CDE is obligated to:
- Either complete the review within 3 days or;
- Arrange an advisory meeting within 5 days and complete the review 2 days after the meeting (total 7 days).
- The final administrative step of IND approval should be done within 3 days after technical review.
- At NDA/BLA stage, NMPA and CDE keep the same review and approval timeline for technical review and final administrative step.
- At the post-approval stage, the drugs approved by the SAP have the highest priority within CDE for monitoring pharmacovigilance and the re-evaluation of safety and efficacy data, which should be conducted in a timely manner.
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:
- CDE proactively monitors the latest update of candidate drugs and takes the initiative to communicate with the sponsors.
- For each candidate drug, CDE designates a specific point of contact to closely follow up with the sponsor and a designated internal review team and report the update to NMPA either daily or weekly.
- Up to August 2020, 10 temporary review teams created and include the most experienced reviewers from three disciplines (pre-clinical, CMC, clinical) to perform assessment for COVID-19 drugs
- A sponsor can ask CDE questions at any time and get responses within 24 hours.
- CDE started drafting the technical guidelines or criteria for IND/NDA/BLA so that the industry can develop their products within the scientific and regulatory framework.
- Rolling submission is allowed for COVID-19 drug applications.
- With regard to clinical trial design, CDE keeps close collaboration with other regulatory agencies and international organizations. For example, CDE introduced two WHO guidelines to industry as soon as they were published – “WHO Target Product Profiles for COVID-19 Vaccines” and “An International Randomized Trial of Candidate Vaccines against COVID-19”.
- Also, CDE keeps an open mind to foreign clinical data and new clinical trial approaches such as the master protocol.
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.