The National Institute of Allergy and Infectious Disease (NIAID) ClinRegs represents a compelling free service aggregating clinical research regulations from around the globe. With frequent updates as they are relevant and available, most recently the China profile was updated to include the National Medical Products Administration’s (NMPA) revised Measures for the Administration of Drug Registration, taking effect July 1, 2020. China represents one of the largest research markets in the world and a place that cannot be ignored. With worldwide pharmaceutical spending to hit $1.5 trillion according to firms such as IQVIA, China’s market will play a prominent role. Keeping compliant in China is a big deal. Learn more about changes such as new modified guidelines for the Preservation of Essential Documents for Clinical Trials.
Most recently, ClinRegs updated requirements from NMPA that took effect by July 1, 2020. They include the following:
- Guidelines for Preservation of Essential Documents for Drug Clinical Trials (published on June 8, 2020) Translation here.
- Clinical Drug Trial Quality Management Standards (published on April 26, 2020) Translation here.
- Measures for the Supervision and Administration of Pharmaceutical Production (Published on March 30, 2020). Translation here.
Visit ClinRegs and support the value-add made possible by NIAID/NIH.
Call to Action: Interested in a nation to nation study start up guide? Check ClinRegs. Interested in specific country expertise? Feel free to contact TrialSite News as some of our principals have decade-plus experience automating study start up for major industry sponsors.