China’s CDE New GCP Requirements for Medical Devices and IVDs in China
On March 31, China NMPA and NHC released an updated version of Good Clinical Practice (GCP) regulation for Medical Devices (announcement 28, 2022), that will take effect on May 1, 2022.
China’s CDE releases Draft Technical Guidelines on the Study Conditions of Dissolution Curves in the Study of Marketed Chemical Drugs
On March 14, 2022, China’s CDE released the “technical guidelines for clinical trials of new chemical enhanced drugs
The USA FDA updated Electric CPP’s with quick response QR code
Beginning on March 25, 2022, the FDA will be adding a unique quick response (QR) code to electronic Certificates of Pharmaceutical Products (eCPPs)
CHINA’S HAINAN BOAO PILOT ZONE OPENS SPECIAL ACCESS FOR NEUROLOGICAL INNOVATIVE PRODUCTS
GRP’s Special program for Accelerated Market Access to China is offered to Foreign Pharmaceutical, Biotech and MedTech companies that have innovative products that are already approved in USA and/or EU or Japan
China NMPA Discloses No. 057 Reference Listed Drug (RLD) List for Public Industry Comments
China’s NMPA announced on March 25, 2022, the issue of the 57th batch of RLD (Reference Listed Drug) for public industry comments.
FDA REMINDS HAND SANITIZER MANUFACTURERS THEY CAN NO LONGER DISTRIBUTE WITH TEMPORARY POLICIES AFTER MARCH 31, 2022
FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (withdrawn on December 31, 2021), they must stop distribution of any remaining hand sanitizer produced consistent with the temporary policies by March 31, 2022.
China’s CDE issues draft guidance for industry comments on “Clinical Guideline of Modified New Chemical Drugs”
On March 14, 2022, China’s CDE released the “technical guidelines for clinical trials of new chemical enhanced drugs
US-FDA Over-The-Counter Monograph Drug User Fee Program (OMUFA)
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
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 […]
The USA FDA Issues Guidance on Enforcement Discretion Policies for Certain FSMA Regulations
On March 11, 2022, the U.S. Food and Drug Administration (FDA) issued guidance on its intent not to enforce certain provisions of five rules that implement the FDA Food Safety Modernization Act (FSMA).
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.