Major Revisions of the New Edition of Drug Administration Law and Drug Registration Regulations
Update time：2017-10-30 15:18:00 Views：
On October 23, the CFDA issued the "Amendment to the Drug Administration Law of the People's Republic of China" (opinion soliciting draft). The directorate stated that the revision of the "Drug Administration Law" was aimed at responding to the 36 important reform measures proposed in the" Opinions on Deepening the Review and Approval System Reform, Encouraging Pharmaceutical and Medical Device Innovation",which is issued by two offices on October 1. In order to implement the "Innovative Opinion" smoothly, the original conflict or missing part was revised and improved.
From the specific revisions, the main changes are as follows:
Fully Implement the Marketing License Holder System
Many of the "opinion draft " point to the Marketing License Holder System, stressing that holders of drug marketing licenses should bear full legal responsibility for preclinical research, clinical trials, production management, and adverse reaction reports.
In addition, Article 32 mentions that changing the holders of drug marketing licenses shall meet the conditions stipulated in this Law and be approved by the drug regulatory agency of the State Council. This means that as long as the transfer of product approval document number complies with laws and regulations, legal transactions can be conducted. This will provide China's innovative drug R&D institutions with the option possibility of light assets and encourage the development of innovative drugs.
Clinical Trial Institutions Was Implemented Record Management
Article 29 of the "opinion draft " pointed out that the method for determining the qualifications of drug clinical trial institutions shall be implemented record management, and the specific measures shall be formulated jointly by the drug regulatory department and the health administration department of the State Council. To increase the clinical trial production capacity of new drugs in an open source manner and to alleviate the shortage of clinical trial production capacity at the current stage.
Clinical Application of New Drugs Was Limited in 60 Days
Article 29 of the "opinion draft " mentioned that the drug regulatory department of the State Council shall decide whether to agree to carry out clinical trials within 60 working days from the date of acceptance of a new drug clinical trial application; If there is no notice within the time limit, the applicant may carry out clinical trials. This is conducive to accelerating the progress of innovative drug listing review and on-site inspections, eliminating rate-limiting steps and accelerating the R&D of new drugs.
Cancel GMP, GSP Certification
Article 10 and Article 16 of the “opinion draft ” referred to the cancellation of the certification of pharmaceutical production quality management standards and the management of pharmaceutical business quality management certification systems. Article 31 mentioned that the raw materials and excipients were revised to be approved together with the drugs. This also means that once an incident occurs, there will be no GMP and GSP buffering and licenses will be revoked directly.