China’s CDE releases Technical Guideline Protocol Amendment during Clinical Trials
Overview: In order to better carry out the scientific supervision of risk-based clinical trials, according to the arrangements of the state bureau, our center CDE organized the drafting of the “technical guidelines for program change during drug clinical trials” and the drafting instructions. Introduction CDE has issued a draft technical guideline about protocol amendment during […]
China’s CDE conducts Live Conference on Pediatric Drugs
On March 1, the first “Live conference on Industry Guidelines for Pediatric Drugs”, co-sponsored by NMPA and CDE held first in-person conference.
China’s NMPA announces that it will expedite review applications for the marketing of Novel Drugs.
China’s CDE has released “Working Procedure for Accelerating the Review of Marketing Application of Innovative Drugs (Trial Implementation)”(hereinafter referred to as “Working Procedure”) for industry comments due March 4th, 2022.
China’s NMPA announces draft Guidelines on the Dossier Acceptance for Chemical Drug and Biologics.
China’s NMPA to improve the transparency and efficiency of the registration dossier acceptance and review, NMPA CDE issued a revision of the guidelines of the registration dossier acceptance for chemical drug and biologics, which is now ready for public comment due by March 4th, 2022.
Brazil’s Chamber for Drug Market Regulation discloses the annual price adjustment for drugs
On January 10th, 2022, Brazil’s Technical-Executive Committee of the Drugs Market Regulation Chamber (CMED) set at 0% (zero percent) the value of the productivity factor (Factor X) referring to the adjustment of drug prices for the year 2022.
China’s NMPA announces The First Regulation for Children’s Cosmetics – Coming into Effect January 2022
The new regulation on children cosmetics is becoming into effect on January 1st, 2022 “Regulation on Supervision and Administration of cosmetics for Children Cosmetics’ (ordinance No,123 of 2021), with the exception of the new labeling requirements for children’s cosmetic products that will come into force on May 1, 2022.
Brazil’s Anvisa approves eighth cannabis-based medicinal product
Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.
China’s NMPA resolves issues regarding current administration on drug distribution
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.