Author: Ping Zhao, PhD, Daniel Scholes Rosenbloom, PhD, and Vikram P. Sinha, PhD on September 15, 2020
On August 3, 2020, China’s National Medical Products Administration (NMPA) announced Draft Technical Guidelines for Model-informed Drug Development (MIDD). This document provides guidance on the rational use of MIDD to promote innovation and efficient drug development in China. This is a welcome advance, as to our knowledge it is the world’s first regulatory guidance specific to MIDD. This draft comes less than 2 years after CPT: Pharmacometrics & Systems Pharmacology (PSP) published a seminal perspective on MIDD in China, authored by NMPA scientists.
The draft guidance addresses not only situations in which MIDD is used for a company’s internal research and development decisions but also cases where modeling directly supports drug registration and marketing. It includes specific recommendations on how to plan, execute, and report the results of MIDD analysis. It also emphasizes the importance of sourcing quality data for modeling and simulation tasks. Rapid uptake of MIDD by Chinese regulators sets a precedent for broader use of MIDD globally, which we hope spurs harmonization among regulatory agencies.
Check out related articles in CPT:PSP’s virtual issue on regulatory MIDD.
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