Key points of review for registration inspecting applications of imported drugs
GAO Zhi-feng
LIN Lan
Abstract：Registration inspecting of imported drugs is an important component of drug evaluation and approval. However, no conformance to requirements results in delay of normal evaluation in reality in many cases. In order to provide guidance to enterprises and improve the efficiency of drug evaluation. We studied the relevant regulations, analyzed the mission sources, summarized the questions during reviewing, and abstracted the common issues and concerns. And then some suggestions were made, mainly including revising guidelines, perfecting information platform, strengthening training and so on.
Keywords：import drugregistrationinspecting
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 853-857 )