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.
HOW TO FILE A DMF FOR AN API IN JAPAN
GRP- blog explains the PMDA’s DFM application process and lists the necessary content needed for API submission to the PMDA.
Brazil’s ANVISA successful implementation of the Medical Device Single Audit Program (MDSAP)
Brazil implements successful Medical Device Single Audit Program (MDSAP) and shows exciting results for the future of international inspection.
FDA RELEASED THE FINAL VERSION OF 6 GUIDANCE’S FOR GENE THERAPY
On 28 January 2020, US FDA released six (6) final guidance documents on Gene Therapy (GT) products.