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.
China’s NMPA Implementation of GB 9706.1:2020
On April 9, china’s NMPA announces they will start implementing GB 9706.1:2020 analogous to IEC 60601-1 Edition 2 for electric device manufacturers.
EMA FAST TRACKS FOR MEDICINES AND VACCINES DURING COVID-19 PANDEMIC
On May 4, 2020, The European Medicines Agency (EMA) details the rapid approval procedures for COVID-19 products which includes scientific advice, rolling reviews, accelerated assessments.
Argentina’s ANMAT Requirements for Facemask Registration
Argentina’s ANMAT releases requirements for Facemaks to act as a protective barrier against Coronavirus and be elgibile for regirstration.
The EU releases updated guidance on conducting clinical trials during COVID-19 Pandemic.
On April 27, 2020 The European Medicines Agency (EMA) released the Guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, the European Commission added advice on distribution, data verification and communicating with authorities.
The Office of Human Research Protection Issues Guidance on the Conduct of Clinical trials During COVID-19
On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response.
New Fees and Requirements for the Registration of DMFs of APIs in China
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
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