Medical Policies Weekly
1. The Center for Drug Evaluation issued three guiding principles for nanomedicine
In order to standardize and guide the research and evaluation of nanomedicine, the Center for Drug Evaluation issued the "Technical Guidelines for Nanomedicine Quality Control Research (Trial)", "Technical Guidelines for Nanomedicine Non-clinical Pharmacokinetic Research (Trial)" and "Nano pharmaceutical Non-clinical Safety Evaluation Research Technical Guidelines (Trial)"on August 27. The three technical guidelines will be implemented from the date of issuance.
2. The Center for Drug Evaluation issued a number of drafts for comments
(1) "Technical Guidelines for Clinical Pharmacokinetic Research of Modified New Drug Modified Release Preparations (Draft for Comments)": The guidelines will describe the general principles for the design, implementation and evaluation of the pharmacokinetic studies of modified release formulations in modified new drugs. It is applicable to the human pharmacokinetics study of modified new drugs such as oral, intramuscular, and subcutaneously administered modified-release preparations and transdermal patches. The guidelines include overview, overall requirements, research content, evaluation, and other considerations.
(2) "Technical Guidelines for Food Impact Research in the Process of New Drug Development (Draft for Comments)": The guidelines are applicable to food impact studies carried out by innovative pharmaceutical preparations that are orally absorbed, aiming to provide technology for rational and standardized food impact research guide. The guidelines mainly include overview, time and general considerations for conducting food impact research, experimental design, research implementation, data analysis, manual drafting suggestions and appendices.
(3) " Technical Guidelines for Research on Human Bioavailability and Bioequivalence of Innovative Drugs (Draft for Comments)": The guidelines will elaborate on the research on bioavailability (BA) and bioequivalence (BE) concept, the purpose of conducting BA/BE research during and after the clinical trials of innovative drugs, the application of BA/BE research at different stages, the methods of human BA/BE research, and the BA/BE research of common dosage forms.
