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 […]
Brazil’s Anvisa and FDA Renew Declaration of Technical Cooperation
On March 8, 2022 Brazil’s Anvisa and the U.S. Food and Drug Administration (FDA) have signed a Cooperation Statement aimed at maintaining and strengthening their collaboration mechanisms.
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.
MEXICO’S COFEPRIS ANNOUNCES THAT THE INTERNAL AFFAIRS OFFICE WILL BEGIN OPERATION TO COMBAT CORRUPTION
On February 27, 2022, Cofepris, Mexico Health Authority, announced that the internal affairs office will start is operations in combating corruption.
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.
REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
US-FDA Formal Meetings with OTC Sponsors
Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]
US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA
On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.
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.
The US-FDA Launches New Reportable Food Registry (RFP)
On January 5, 2022, The FDA published a new, interactive public data dashboard that allows anyone to view historical data from the Reportable Food Registry (RFR).
The US FDA deems final Order for Sunscreens
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.