Objections resolution of drug evaluation -Trial

On September 1, the national medical device administration (NMPA) issued an announcement on the resolution of objection to drug evaluation (Trial) (No. 94/2020), which shall come into force as of the date of promulgation. If the applicant raises an objection to the review conclusion made by the drug evaluation center-DEC, the drug review evaluation shall organize the objection handling. Within 5 days after the completion of the comprehensive technical review, the DEC shall inform the applicant of the review conclusion, reasons, right, channel, method, items and time limit of the applicant’s objection through the website. The applicant can raise objectionRead More →

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