Medical network - on March 17, according to the state council about the opinions of the drug review of medical equipment examination and approval system reform "(guo fa [2015] 44) requirements, to encourage overseas unlisted new drug approval in domestic and overseas synchronous conducting clinical trials, publicly listed company shorten the time interval, to meet the public demand for new drugs in clinical, the state food and drug supervision and administration bureau drafted the administration of the state food and drug supervision and administration of imported drug registration management related matters about adjusting decision (draft)", is to solicit opinions from the public. The relevant units and the social people from all walks of life can be on April 20, 2017, to present an opinion by the following way:
1. Login information network of legal system, Chinese government into home page on the left side of the "draft regulations rules and comment system" put forward opinions and Suggestions.
2. Will advice by E-mail to hxypc@cfda.gov.cn, and let us know the email subject "adjust the imported drugs registration matters decided opinion".
The food and drug supervision bureau
On March 17, 2017
State food and drug supervision and administration bureau
Imported drug registration management related matters about adjusting decision
(draft)
According to the state council on reform of the opinions of the drug review of medical equipment examination and approval system "(guo fa [2015] 44) requirements, to encourage overseas unlisted new drug approval in domestic and overseas synchronous conducting clinical trials, publicly listed company shorten the time interval, and satisfy the public demand for new drugs in clinical, which adopted by the state food and drug supervision and management of the administration research conference, to make the following adjustment imported drug registration management related matters:
A, in China with international multicenter drug clinical trials, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has entered the stage II or III clinical trials, vaccine except drugs.
Second, for international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listing application for registration of pharmaceuticals, Registration and listing shall be implemented by the drug registration management measures "and other related documents.
Three, for applying for import of chemical drugs and drug treatment with biological products innovation, cancellation shall obtain overseas pharmaceutical manufacturers in producing countries or regions listed licensing requirements.
Prior to the release of four, for the purposes of this decision, has been accepted by international multicenter clinical trial data without doing the import registration of clinical trials, in conformity with the requirements, can approve the import.
This decision in years Date of implementation. Drug administration of the relevant rules and regulations about the imported drug registration management do not agree with this decision, in accordance with this decision. |
