Brazil’s ANVISA Announces Medical Device Registration 2022 Updates
ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.
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.
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
China’s NMPA introduces new guidance for COVID-19 drug clinical trials
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.
Brazil’s Anvisa produces new committee for the accelerated submission of COVID-19 related clinical trials.
Anvisa has established a Committee for Evaluation of Clinical Studies, Registration and Post-registration of Drugs for prevention or treatment of Covid-19.
Brazil’s Anvisa publishes Service Orientation (OS) that may provide simplification of clinical trial applications (DDCM)
Anvisa pusblishes Service Orientation (OS) 88/2020 provides details on procedures for reviewing documents required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active BE drugs or placebos.
US FDA releases its first patient focused drug development (PFDD) guidance
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.
Antimicrobial Drugs Clinical Study Regulations Harmonization
The FDA, EMA and PMDA aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.
FDA Waiving the Informed Consent for Minimal Risk Clinical Studies
On November 2018, FDA proposed a new rule that will allow investigators to request a waiver of the informed consent from the IRB for minimal risk clinical studies.
CFDA New Clinical Data Requirements for Foreign medical devices
CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]