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US FDA releases draft guidance for Cannabis and Cannabis- derived Compounds used in Clinical Research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.
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.
The Office of Human Research Protection Issues Guidance on the Conduct of Clinical trials During COVID-19
On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response.
Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.