Brazil’s Anvisa is approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S

Brazil’s ANVISA has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative.
Registration Of COVID-19 Rapid Tests with Brazil’s Anvisa- Required Documents

Anvisa published the Resolution (RDC 348/2020) to speed up the evaluation of new products for detection of the new coronavirus (SARSCoV-2). Check out GRP’s blog on all the required documents necessary to register COVID-19 rapid tests with Brazil’s Anvisa.
Australia’s TGA GMP inspections during COVID-19

During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
Brazil’s Health Authority requires Registration Holders to send daily information to ANVISA regarding drugs necessary in COVID-19 Pandemic

Companies that hold drug registrations must provide Anvisa daily information about the manufacture, import and distribution of anesthetics, sedatives, neuromuscular blockers and adjuvant agents, among other drugs used to maintain the lives of patients infected with the new coronavirus (Sars-CoV-2).
China’s NMPA introduces new guidance for COVID-19 drug clinical trials

China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers.
United Kingdom’s MHRA releases a list of exempted medical devices

United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.
Steps to take if you have a COVID-19 confirmed positive worker: CDC Recommendations

The FDA encourages and outlines major steps to be taken as per the CDC recommendations to help prevent and slow the COVID-19 in the office.
FDA holds up UDI enforcement for Class I device

The FDA delays the enforcement of Unique Device Identification (UDI) for Class I medical devices and will come in action from 24 September 2022.
Colombia’s Invima modifies administration measures due to COVID-19 pandemic

Invima changes the transitional administrative measures under Resolution 2020012926 of 3rd April 2020 due to COVID-19
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
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.
Brazil’s Anvisa outlines Pharmaceutical Registration Exceptions due to COVID-19

Anvisa has published a Resolution RDC Nº 392 2020, that defines the criteria for the application of exceptions to Good Manufacturing Practices and Import requirements for drugs and pharmaceutical during COVID-19.