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.
Brazilian Ministry of Health will train professionals to identify patients with rare diseases
Among the actions the Brazilian Federal Government will offer a free training course on the subject, in addition to the campaign mascot calling attention to diagnosis and information on the subject.
Distribution Process of the Covid-19 vaccines in Brazil
From the lab to the arm: learn about the Ministry of Health’s Covid-19 vaccine trial in Brazil.
Anvisa allows the regularization of Radiopharmaceuticals via Notification Process
Following Resolution No. 451/2020 that came into effect in February 2021, Anvisa regulates radiopharmaceuticals exempt from registration upon notification process.
South korea’s MFDS announces revision of Standards and Specifications for Health Functional Food on functional ingredients
The revision strengthens safety management standards for 8 functional ingredients.
Australia’s TGA Medical Device Reform to reclassify certain medical devices
TGA has decided to reform their medical device classification due to safety issues identified and to further harmonize to the European Union.
Anvisa publishes new Technovigilance Manual 2021
The new Technovigilance Manual improves health regulation to meet the challenges posed by new technologies and the speed with which reality is changing.
WHO approves emergency use of CoronaVac, Butantan Institute’s vaccine against Covid-19
According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
Anvisa approves clinical study with advanced therapy product against Covid-19
Stem cell-based product, intended for the treatment of patients with Covid-19, will be tested in Brazil.
Guidebook on Requesting Emergency Use of Drugs for Covid-19
The guideline describes the minimum technical requirements to be presented by the companies for temporary Authorization for Emergency Use of drugs for Covid-19.
FDA publishes ICH Q12 guideline for Post Approval CMC changes
Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product. Regulatory tools and […]
EU Medical Device Regulation Technical Documentation Structure and Requirements
The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements.