Medical network - February 23 February 22, the CFDA website general office of the food and drug supervision bureau notice about drug technology transfer related matters, to the deployment of related work.
On February 22, 2013, the state food and drug administration issued the state food and drug administration about ready to implement the newly revised drug production quality management standard in the process of drug technology transfer matters related to notice (the food drug safety note [2013] no. 38, hereinafter referred to as the "notice"). The "notice" is the implementation of the new revised drug production quality management standard (CGMP) bridging document, at present, the transition of drug GMP implementation work has finished, the corresponding technology transfer work should be stopped.
To be involved in the "notice" drug technology transfer follow-up work, the CFDA requirements, since March 1, 2017, has won the state food and drug supervision and administration bureau approval authorization of provincial food and drug administration to stop according to the "notice" to accept the drug for technology transfer registration procedures and requirements.
On March 1, 2017 has been accepted and submit a research materials of drugs for technology transfer registration, the provincial food and drug regulator continues to develop technical evaluation work in accordance with the "notice" requirements, carefully review, guard a pass strictly, does not meet the requirements, determined not to examination and approval, to ensure that the technology transfer process standard is not reduced.
On March 1, 2017 has been accepted but not yet submitted research materials, application for registration of the drug technology transfer related provincial food and drug supervision bureau according to the requirements of the notice of acceptance, the applicant must complete and submit the relevant technical research work in three years research materials, fails to submit, the corresponding technology transfer registration shall not be approved directly.
"Notice" after stop execution, drug technology transfer between enterprises in accordance with the regulation on administration of the drug technology transfer registration (the food drug safety note [2009] no. 518) of the procedure and requirement to declare the supplement, managed by the state food and drug administration for review for approval. State food and drug supervision and management of administration is studying simplify the process of drug technology transfer related policy. |
