Opening Up America Again: The Phased Approach & OSHA recommendations on Work Safety
The United States White House and Center of Disease Control (CDC) have released on May 14 the phased approach on “Opening Up America Again.”
Social Media Advertising in Australia
Therapeutic Goods Administration (TGA) oversees advertisement of goods in Australia and has set forth the requirements of advertising
Brazil’s ANVISA issues new Resolution for the direct import of products by Healthcare Centers
On May 12, 2020 ANVISA published new resolution RDC Nº 383 that addresses the direct import of products by health centers.
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 .
China’s NMPA updates standards on quality management system of Drug Clinical Trials
On April 23, 2020, China’s NMPA issued the revised Standard for Quality Control of Drug Clinical Trials (No. 57 of 2020) and will be implemented on July 1.
China’s NMPA Random Inspections of COVID-19 Medical Devices Manufacturers
On April 14, 2020, China NMPA published a new notice to Enhance Quality Inspection for Sterile and Implantable Medical Devices new notice on its new plan to perform random inspections to medical device manufacturers in China
Brazil’s Anvisa Updates medical device regulations during COVID-19 pandemic.
Anvisa’s updated regulation RDC 379/2020 provides requirements for medical device manufactures and identifies devices eligible for priority importation.
Pharmacovigilance in China
On 2017, China began the harmonization of their pharmacovigilance structure when they joined the ICH. GRP’s blog breaks down the structure of china reporting system and the requirements of a PMF.
Registration of a New Molecule in Mexico
In Mexico, manufacturers who seek market authorization (Sanitary Registration) for their new drug must first request approval of their products as new molecules from the New Molecules Committee (NMC) of COFEPRIS
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.