China’s CDE- Guidelines for Summary of Adverse Drug Reaction Data in Labeling of Antineoplastic Drugs
China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.
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 Resolution RDC No. 590/2021 published on December 29th, 2021, the List of Brazilian Common Denominations (DCBs). The regulation included 28 new designations and changed two.
Amendment of Resolution No. 9/2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.
According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
Stem cell-based product, intended for the treatment of patients with Covid-19, will be tested in Brazil.
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
US FDA releases draft guidance for Cannabis and Cannabis- derived Compounds used in Clinical Research
The US FDA released a new guidance on July 2020 on the clinical research and development of drugs containing cannabis or cannabis derived compounds.
China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers.
Anvisa publishes a Technical Note 22/2020 updating the guidelines for sponsors, research centers and investigators involved in conducting clinical trials.
The US FDA has released its first patient focused drug development (PFDD) guidance. This guidance is the first methodological guidance( referred as guidance 1) and that will be followed by 3 more guidance’s on this topic.