Recently, at the press conference held by the State Council, Bi Jingquan, director of the State Food and Drug Administration, disclosed the new policy for drug review in 2017. It is clearly stated that it is necessary to establish a general electronic technical documentation system for drugs (eCTD system), and strive to implement electronic declaration and review according to the new system by the end of this year.
This reform will undoubtedly reduce the burden on enterprises, especially overseas enterprises. After the implementation of the eCTD declaration, the technical requirements and formats for the enterprises declared overseas to apply to China are basically the same.
So what exactly is the eCTD system? Let's follow the small series to understand.
What is the eCTD system?
eCTD is the abbreviation of ElectronicCommonTechnical Document, a form of information transfer from pharmaceutical companies to drug regulatory agencies based on the requirements of the Common Technical Document (CTD). The pharmaceutical company may submit the registration documents to the administration authority in the form of eCTD via CD, DVD, U disk or a dedicated network submission channel.
eCTD implementation in countries such as the European Union
The US FDA began piloting eCTD as early as 2003. According to statistics released by the FDA at the end of 2014, more than 80% of NDAs were submitted by eCTD, and more than 50% of DMFs in the DMF's citation list exist in the form of eCTD. Although the FDA did not impose mandatory requirements for eCTD filings, the FDA requested in May 2015 that new drug applications (NDAs), generic applications (ANDAs), and biological products will be available from May 15, 2017. Many documents submitted to the Center for New Drug Evaluation and Research (CDER) and the Center for Biopharmaceutical Evaluation (CBER) of the US Food and Drug Administration, such as BLAs and Drug Masters (DMF), must be in eCTD format. submit.
The European EMA began piloting eCTD in 2003. Since 2010, the centralized procedure mandated eCTD. EMA has been promoting the electronic registration of pharmaceuticals. The ultimate goal is to eliminate all physical media and unify the standards for electronic submission. EMA issued a timetable for electronic submission on March 13, 2015, requiring DCP (decentralized approval process) to be submitted as eCTD in the third quarter of 2015; in the first quarter of 2017, MRP (mutual recognition procedure) must Submitted by eCTD; in the first quarter of 2018, all registration procedures must be submitted by eCTD; for the first time in 2018, ASMFs in DCP, MRP and CP (centralized approval procedures) must also be submitted as eCTD.
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