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

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.