Brazil’s Anvisa releases a new Adverse Event Notification Form
Brazil’s Anvisa introduces new tool enables faster and easier notification of drugs and vaccines.
FioCruz reinforces the position adopted by Anvisa, EMA and WHO on vaccine safety
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Brazil’s Pharmacovigilance: The Program of Risk Management and Pharmaceutical Technology of Vaccines
A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.
Mexico’s Cofepris Modifies Pharmacovigilance Regulation: NOM 220-SSA1-2016
On October 30 2020, Mexico’s COFEPRIS, modifies NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.
The UK’s MHRA provides more provisions on Pharmacovigilance
UK MHRA publishes UK, (12A) to Regulation 205A, providing provisions for pharmacovigilance activities and PMSF requirements.
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.