Study on Technical Review Standard of the Re-registration of the Domestic Drugs Under the Background of New Regulations

OBJECTIVE To establish technical review standard of the re-registration of the domestic drugs under the background of new regulations. METHODS Through the analysis of drug laws and regulations and review cases, the review elements of the re-registration of the domestic drugs were preliminarily established, and the improved Delphi expert consultation method was used to conduct two rounds of consultation on 33 drug registration review experts, and the consultation results were statistically analyzed. RESULTS A set of technical review criteria for the re-registration of the domestic drugs was developed, including 8 first-level elements and 41 second-level elements.CONCLUSION The technical review standards constructed in this study are expected to promote the standardization of drug re-registration technical review and improve the quality of drug re-registration technical review.