An Introduction to Registration of Food Supplements in China
In China, nutrient supplements are regulated as one category under the umbrella term health food.
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.
Australia’s GMP Regulations during the COVID-19 Pandemic
All medicine manufacturers must receive approval from the TGA prior to manufacture and supply of products in Australia.
FDA Releases 2022 New User Fees
The US Food and Drug Administration (FDA) has published the user fees for 2022 that will be collected from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities.
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 […]