Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China.
As a continued commitment to meet clients’ needs and conform to local Chinese regulations, the Central Laboratory Services Shanghai team (CLS Shanghai) provides guidance to our clients to navigate CFDA inspections. Backed by more than 10 years of experience in China, the CLS Shanghai team delivers a deeper understanding of CFDA regulatory and operational requirements and helps clients with a standardized process and corresponding documentation.
Together Throughout the Entire Inspection Process
Clients are assigned dedicated project management and quality assurance personnel to serve as contacts for each study. These team members provide assistance throughout the entire inspection process:
- Client Self Check – CLS Shanghai assists clients by coordinating support activities, such as providing relevant documentation, attending client meetings to discuss and address the issues from clients and sharing relevant CFDA inspection experience along the way.
- Inspection at Investigator Sites – During the inspection, CLS Shanghai prepares for potential requests, even during non-business hours, provides required documentation within typically short timelines, and arranges one to two team members to assist with support at investigator sites, per a request from the CFDA.
- Inspection at the CLS Shanghai Site – CLS Shanghai makes personnel available, even over the weekend, to accommodate what is normally a two-day CFDA inspection. Many times, the inspection is required with very little notice. Prior to the CFDA inspection, CLS Shanghai routinely prepares about 30 types of documentation from across lab functions to ensure there is no delay in responding to CFDA requests. If a referral laboratory has been engaged, CLS Shanghai will coordinate these efforts on behalf of the client.
- Post Inspection – CLS Shanghai will work with the client to respond to findings within the required timeline, and attend Center for Food and Drug Inspection and/or Center for Drug Evaluation meetings for a face-to-face explanation of the response.
Experience and Feedback to Help Define Best Practices
Between 2015 and June of 2017, the CLS Shanghai team completed CFDA inspections on 41 studies (30 drugs) in various phases of development and, to date, 12 of those studies (9 drugs) have received CFDA approval. Lessons learned from these inspections are being incorporated into the 11 studies with ongoing inspections currently underway with CLS Shanghai. In addition, CLS Shanghai has hosted the CFDA personnel for regulatory and drug development training.
Continued Focus on Strengthening Relationships in China
In addition to direct involvement in inspections, CLS Shanghai proactively works with clients to streamline the preparation process and optimize the operation procedure to more efficiently meet the CFDA requirements. Specifically, CLS Shanghai has helped clients develop an internal process for CFDA inspections to provide a consistent global quality experience and to work in partnership with the CFDA. In addition, CLS Shanghai has organized a series of educational workshops between clients, investigator sites and the CFDA to support open dialogue and share best practices.
As the largest global central laboratory, we have continuously invested in improving and sustaining high quality and compliance at both global and local laboratories. Leveraging this global experience, we are not only able to help our clients quickly address questions from the CFDA, we can provide the confidence clients need to be successful in an emerging and critical market for new medicines. Learn more about our central laboratory solutions here.