The Newly Enacted CARES Act reforms the FDA OTC Monograph Process
The United States Food and Drug Administration reforms the Over the Counter (OTC) process under the CARES Act signed by Congress in March ’20 to provide emergency relief affected by the COVID-19 pandemic.
Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19
The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)
China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .
Brazil’s Anvisa Registration Requirements for COVID-19 Rapid Test
On May 14, 2020 Brazil’s Anvisa published information on the requirements of the registration of the rapid tests for COVID-19 in Brazil.
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.