HSA releases New Initiatives for Registration of Therapeutic Products- Aug 2021
As part of HSA’s ongoing efforts to enhance clarity in regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry, the HSA has introduced an online self-guided tool for post-approval minor variations application and a DMF acknowledgment email and guidance on deficiency matters.
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.
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.
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.
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.