Key Points and Strategies for Consistency Study of Sustained- or Controlled-Release Generic Drugs

The consistency evaluation of quality and efficacy of generic drugs in China is a systematic project that was first launched by the State Council in January 2012 and then extensively carried forward in August 2015. However, the propelling speed of extended-release generic drugs is particularly slow. Referring to domestic and foreign literatures and combing practical work experience, the author tries to put forward some personal opinions on some key links such as comprehensive consideration and design, selection of reference preparation, pre-formulation research, research on formulation technology, research on release method and pilot scale production, so as to provide reference for related researchers.