Study and enlightenment on drug communication system in US and EU
YU Lian-lian
LIN Lin
TIAN Li-juan
Abstract：To compare the drug communication system and operation mode of FDA and EMA,and put forward the suggestions for improving the drug communication system in China.The communication systems of innovative drugs,complex generic drugs,orphan drugs,biosimilars of FDA and EMA were collected and sorted out.The implementation status of China's drug communication system was analyzed,and the corresponding suggestions were put forward.FDA and EMA have established communication system for different types of drugs based on the drug development life cycle and product characteristics,and actively engaged with other international regulatory agencies and stakeholders to facilitate new drug development.In contrast,the existing types of drug communication systems in China are slightly weak in terms of product characteristics,and the responses to communication are still insufficient.China still needs to actively seek the opportunities for international cooperation.China's communication system is still unable to fully meet the needs of the applicant's drug research and development guidance.Based on the experience and ideas of foreign communication systems,China should refine the types of communication system,try to build review cooperation with other international regulatory agencies,improve the quality and transparency of replies,as well as the efficiency of drug research and development and review.
Keywords：communication systemdrug registrationscientific adviceregulations
Publication Date：2024-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 2193-2201 )