The State Food and Drug Administration Solicits Opinions on the New Regulations on Review Procedures to...

With the encouragement and support of relevant laws, regulations and policies, my country's innovative drug research and development has achieved outstanding results. According to statistics, in the past five years, a total of 59 countries in my country have been approved for marketing of Class 1 new drugs, and 22 last year, a new high. The author was informed that, in order to encourage the research and creation of new drugs and speed up the review of innovative drugs, the Center for Drug Evaluation of the State Food and Drug Administration recently issued a review on the "Center for Drug Evaluation to Accelerate the Review of Innovative Drug Marketing Applications (Trial) (Draft for Comment)". (hereinafter referred to as the "Working Procedures") for public comments.
 
According to the "Working Procedures", the scope of varieties suitable for "expedited review" is "innovative drugs included in the breakthrough therapy drug program", and the applicable stage is "the applicant has completed the exploratory clinical trial, and has been able to carry out key clinical trials. The conditions are to be approved before listing”, and the review time is limited to 130 days.
 
In order to speed up the progress of variety review, applicants are encouraged to submit a registration test to the drug inspection agency before the official application for marketing for the varieties that are applicable to the "Working Procedures". And within 10 days after the acceptance, complete the electronic push of the start-up registration verification task.

In recent years, my country's pharmaceutical innovation capabilities and systems have been rapidly improved, and major scientific and technological research has been advanced in the fields of biotechnology and original innovative drugs. With the continuous improvement of national policies, many domestic enterprises have also continued to increase the research and development of innovative drugs.