Social Media Advertising in Australia
Therapeutic Goods Administration (TGA) oversees advertisement of goods in Australia and has set forth the requirements of advertising
EMA waives GMP inspection fees during COVID-19
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.
Registration of Biologics in Brazil
Trying to register your biologic in Brazil? Read GRP’s blog to get a greater understand of the regulations, pathways and timelines.
Australia’s TGA lifts pre-approval for medicinal advertisements in “specified media”
As of 1 July 2020, medicine advertisements in specified media will no longer need pre-approval from Australia’s (TGA)
How to Register a Vitamin with Australia’s TGA
In Australia, the Therapeutic Goods Administration (TGA) regulates all vitamins for safety and quality. The TGS has set specific requirements such as permitted ingredients, indications and GIMP for vitamins .
Global Regulatory Partners is Joining the Fight Against Coronavirus (COVID-19)
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators
To increase the availability of Face Masks Intended for the protection of health care professionals the FDA will expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.
Anvisa Clarifies on use of Chloroquine and Hydroxychloroquine as potential treatments of COVID-19
ANVISA clarifies that there are no conclusive studies proving the use of hydroxychloroquine and chloroquine as a treatment for COVID-19.
Do You Qualify for FDA Emergency Use Authorization (EUA) for Coronavirus (COVID-19)?
If you are a Medical Device, or Pharmaceutical that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.
FDA publishes guidance on conducting clinical trials during COVID-19 Pandemic.
On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.
How to make Hand-Sanitizer: WHO and FDA recommendations
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Regulatory Challenges faced by Cosmetic Companies
Cosmetics is a dynamic industry, with new novel products ready to market it puts significant pressure on companies to understand global regulation and registration processes in order to reach consumers and markets globally.