SFDA To Segregate Responsibilities Of Drug Administration, Appraisal And Approval
This article was originally published in PharmAsia News
Executive Summary
According to its recently published reorganization plan, China's State FDA will spread the control of drug administration, appraisal and approval into different bureaus. For instance, a new food permission bureau will be set up to exclusively approve food, cosmetics and healthcare products, while other bureaus will manage related responsibilities. In addition, SFDA will transfer the jurisdiction of technology appraisal on drug and medical devices to its lower level institutions, the National Institute for the Control of Pharmaceutical and Biological Products, Chinese Pharmacopoeia Commission, Center for Drug Evaluation and Medical Devices Evaluation Center. SFDA will now approve and supervise healthcare products. The constant policy revision means imminent change in the industry's product brand names, R&D and classification. (Click here for more - Chinese Language)
You may also be interested in...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.