About the chemical medicine pharmaceutical research IND application data submission of notice
With the implementation of the strategy of national major drug discovery and drug development of globalization, in our country to establish innovative drug research and development regularity of IND mechanism has become a top priority. In recent years, based on the review of the practice of innovative drugs, drug approval center and draw lessons from foreign mature experience in a series of exploration, aims to build perfect encourage innovation and risk control and control mechanism. On the one hand, the center will be based on function key the following work: clinical trial data management, clinical trial scheme of network registration, clinical trial in the process of supervision, the establishment of the clinical trial related system (ethics commission, an independent data monitoring committee, etc.), the implementation of the global synchronization in the field of conditional treatment research and development, explore the human body the first dose of study, to improve China's capacity for clinical trial design and path control. Exploring chemical medicine IND stage, on the other hand, the review of different professional strategy, and through the review template forms be cured, in order to make technical requirements adapted to the objective laws of pharmaceutical research.
Pharmaceutical research depth and breadth of innovative medicine is extending unceasingly along with the progress in research and development. According to the characteristics of innovative drugs pharmaceutical research center, try to establish the chemical medicine IND stage pharmaceutical research data submission, communication and other measures, to constantly enrich and improve the mechanism of the innovation of drug IND. Will now and submit the relevant data of chemical medicine IND application (Ⅰ, Ⅱ clinical) pharmaceutical research information summary table (try out) ", "pharmaceutical chemical medicine IND application research of the annual report (try out)" to be published, related to the applicant, please pay close attention to.
To review into the center task management IND channel varieties, from the date of this announcement, please submit the applicant in accordance with the following requirements related to pharmaceutical research data:
A, to apply for phase I and II clinical research species, except in accordance with the declaration data available for submission of the existing pharmaceutical research data, after the review task into the center, species included in the monthly review plan before the applicant through center website, please submit a word version of the "electronic submission" channel "chemical medicine IND application (Ⅰ, Ⅱ clinical) pharmaceutical research information summary table". Information summary of data and information should be consistent with the declared data.
Second, for the first time allowed as innovative drugs for clinical study, from the date of the applicants to submit annual "chemical medicine IND application for pharmaceutical research annual report". Annual report is to support the follow-up clinical study and declare in the production of pharmaceutical review important data, please make sure that the research information and data are complete, true. At present, the applicant may submit paper by way of document, electronic data submission prior notice.
Prior to the release of three, for the purposes of this notice has been allowed to conduct clinical studies of innovative drugs, please the applicant to submit before August 30, 2012 chemical medicine IND application for pharmaceutical research annual reports, including from the date of the last time to clinical research
The medicine changes and update the matters.
Four, to include task management center evaluation IND channel of international multicenter clinical application reference. For the problems discovered during the trial, the applicant can "information feedback" channel through center website timely communication with the center.