TGA announces new fee schedule and delays in proposed regulations
For the fiscal year 2020-2021, TGA (Therapeutic Goods Administration) announces an updated fee schedule which comes in effects from July1, 2020.
China’s NMPA releases new regulation on the Registration of Biologics in China
China’s NMPA releases on June 30,2020, No. 43 of 2020 to regulate biologics efficiently, NMPA has divided biologics into 3 categories.
China’s CMDE releases new procedure for medical device registration
China’s Center for Medical Device Evaluation (CMDE) released 2 announcement revising medical device registration procedures.
Brazil’s CMED urges Covid-19 pharmaceutical companies to Apply Minimum Discount
In Brazil, drugs and pharmaceuticals must follow “the minimum discount rule” of the Drugs Market Regulation Chamber (CMED) for public procurement of drugs and pharmaceuticals inputs
FDA Updates Medical Device Establishments Inspection Processes and Standards
FDA released a final guidance on inspections of medical device establishments requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments
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
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.
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
US FDA Facilitates Intellectual Property Rights For Dietary Supplements
The US FDA proposes useful tools to register innovative dietary supplement for New Dietary Ingredient – Master file (NDI-MF).