Author: Ping Zhao, PhD and Vikram Sinha, PhD on December 21, 2018 
CPT: Pharmacometrics & Systems Pharmacology (PSP) welcomes the first model-informed drug development (MiDD) perspective from China’s National Medical Products Administration (NMPA, former China FDA) to join the journal’s regulatory MiDD article family. The article Model-Informed Drug Development and Regulation in China: Challenges and Opportunities, was written by staff from the agency’s Office of Biostatistics and Clinical Pharmacology, Center for Drug Evaluation. Established in the midst of the agency’s recent reform initiatives aimed at meeting public health demands, the office has been building MiDD review capabilities by developing guidelines and applying state-of-the-art modeling and simulation methods to support review decisions. The perspective in PSP reflects the agency’s determination to promote innovation in pharmaceutical R&D and regulatory reviews and to keep pace with global regulatory science. The publication of Chinese agency’s first MiDD perspective should prompt wider recognition and application of novel MiDD methods by researchers and product developers in China. While global efforts in harmonization are ongoing, perspectives as such encourage practitioners of MiDD that global regulatory thought leaders have similar goals in mind.
PSP is excited to announce its newest Virtual Issue on the topic of Regulatory MiDD, which includes the following articles:
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