Pharmaceutical Industry News

Analysis of regulation, quality, innovation, market and trends in Europe and Latin America.
Biosimilar medicines that are part of the standard

Anvisa approves regulations for biosimilars

New standard eases requirements and simplifies product development, promoting a transparent regulatory environment....
Updating procedures for new licensing imports

Protocole the Import License after NCM reclassification

Anvisa updates procedures for licensing imports, providing new guidelines for cases of NCM reclassification....
Anvisa approving new regulatory impact report

Report approved to revise regulations on imported goods

The Board of Directors has approved the Regulatory Impact Report to revise the regulations on imported goods....
Sao Paulo Cannabis Protocol

SP approves cannabidiol and tetrahydrocannabinol protocol

Resolution SS 107/05/24 directs doctors to prescribe cannabidiol and tetrahydrocannabinol for specific syndromes....
Person registrating a medical device

Anvisa to use external analysis to register medical devices

The measure speeds up the evaluation of products already approved by foreign authorities, reinforcing regulatory confidence....
Applying regulations on medical devices

Decree-Law implements EU regulation on medical devices

A new regulation implements EU guidelines for medical devices, setting standards for operators and market monitoring....

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