Brazil’s Anvisa Releases New Technical Note on the conduct of clinical trials during the COVID-19 pandemic.

Brazil’s Anvisa issues technical note that gathers the latest guidelines on the conduct of clinical trials in the face of the new coronavirus pandemic.
EU Changes IVDR Plan due to COVID-19

The European Union’s new In Vitro Diagnostic Regulations (EU IVDR 2017/746) action is delayed due to COVID-19.
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
China’s NMPA announces the 2020 Medical Device Industry Standard Revision Plan

On March 2020, China’s NMPA issued the 2020 Medical Device Industry Standards Revisions Plan. They revision produced 9 mandatory and 77 recommended standards for Medical Devices.
The FDA Ventilator Requirements for EUA

To face the increase demand of ventilators and other respiratory devices in USA due to the COVID-19 pandemic, US FDA released a new guidance on the FDA expedite review of new ventilator under the Emergency Use Authorization (EUA) program.
Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials

Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
The FDA Introduces the Coronavirus Treatment Acceleration Program (CTAP)

The FDA introduces the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of safe and effective life saving treatments against Coronavirus.
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
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.