US FDA releases COVID-19 vaccine guidance

The United States Food and Drug Administration (USFDA) recently released a guidance for COVID-19 vaccine demonstrating at least 50% effectiveness in a placebo-controlled trial.
EMA waives fees for orphan drug consultations

European Medicines agency (EMA) updates their executive decision for orphan drug development of waiving fees for academic organizations.
Brazil’s Anvisa updates conduct of clinical trials with Technical Note 22/2020

Anvisa publishes a Technical Note 22/2020 updating the guidelines for sponsors, research centers and investigators involved in conducting clinical trials.
Webinar: Brazil Cosmetic Regulatory Compliance and Importation Requirements

GRP has teamed up with ChemLinked to bring you a webinar on Cosmetic Regulation and requirements in Brazil. The webinar will introduce the Brazilian cosmetic market, then specify the cosmetic regulatory framework, including cosmetics registration, labeling, and advertisement, and finally outline regulatory requirements for the importation of cosmetics into Brazil
PMDA Approach to Artificial Intelligence (AI) based Medical Devices

PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.
Mexico Prohibits the importation of electronic cigarettes by presidential decree (02/2020)

The Government of Mexico, concerned about the health of Mexicans, Prohibits the importation of electronic cigarettes by presidential decree.
The FDA publishes Guidance for Nutrition and Supplements Facts Labels for Small Entity Compliance

FDA publishes guidance for final rule intended to help small entities comply with the nutrition facts labeling requirements
The FDA publishes FY 2019 GDUFA Science and Research Report

The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
Anvisa’s Call Notice 2/2020 : Similar Drug Notice

On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.
Accelerated Approval of Detection Reagents of Coronavirus in China

The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
BRAZIL APPROVES IMPORTATION OF MEDICAL CANNABIS

ANVISA new regulatory framework creates a new class of products subject to health surveillance: Cannabis- based products.
China Health Authority CDE Cancelling Face-to-Face Meetings with Companies to Prevent the Spread of Coronavirus

On February 3, 2020 China’s CDE has taken some measures to prevent and limit the spread of corona-virus out from the city of Wuhan.