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Tag: medicines

Anvisa approves release of vaccine and medicine against monkey pox

Anvisa approves release of vaccine and medicine against monkey pox

Brazil’s Anvisa approves eighth cannabis-based medicinal product

Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.

Brazil’s Chamber for Drug Market Regulation discloses the annual price adjustment for drugs

On January 10th, 2022, Brazil’s Technical-Executive Committee of the Drugs Market Regulation Chamber (CMED) set at 0% (zero percent) the value of the productivity factor (Factor X) referring to the adjustment of drug prices for the year 2022.

Brazil’s Anvisa approves eighth cannabis-based medicinal product

Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are eight cannabis products approved by ANVISA.

Brazil’s Anvisa approves two new cannabis-based products

The Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are seven cannabis products approved by ANVISA.

Brazil’s Anvisa approves new regulatory framework for low-risk drugs subject to notification

The Resolution RDC No. 576/2021 and the Normative Instruction No. 106/2021 expanded the list of drugs that may have simplified registration. The notification process aims to simplify the regularization of low-risk drugs.

Brazil’s Anvisa expands the Authorization for Clinical Trials with Medicines in Brazil

Amendment of Resolution No. 9/2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.

Mexico’s Cofepris Submits preliminary draft amendment of the Health Products Regulation

On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.

Colombia’s Invima modifies administration measures due to COVID-19 pandemic

Invima changes the transitional administrative measures under Resolution 2020012926 of 3rd April 2020 due to COVID-19

Australia’s TGA lifts pre-approval for medicinal advertisements in “specified media”

As of 1 July 2020, medicine advertisements in specified media will no longer need pre-approval from Australia’s (TGA)

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