The Brazilian health authority ANVISA (Agência Nacional de Vigilância Sanitária) has recently updated the drug registration process in Brazil. The new process, which was implemented in January 2023, is designed to be more efficient and transparent.
The new process has two main phases:
Phase 1: The applicant submits a pre-market assessment (PMA) dossier to ANVISA. The PMA dossier includes information on the drug's safety, efficacy, and quality.
Phase 2: If the PMA dossier is approved, the applicant submits a marketing authorization application (MAA) to ANVISA. The MAA dossier includes information on the drug's labeling, packaging, and pricing.
The new process has a number of advantages over the old process. First, the PMA dossier is a single document that includes all of the information that ANVISA needs to assess the drug's safety, efficacy, and quality. This makes the process more efficient for both the applicant and ANVISA.
Second, the new process is more transparent. ANVISA publishes all of the PMA dossiers on its website, which allows the public to see the information that ANVISA is considering when making a decision about a drug's registration.
The new drug registration process in Brazil is a positive step towards ensuring that safe and effective drugs are available to Brazilian patients. The process is more efficient and transparent, which will help to speed up the time it takes for new drugs to reach the market.
Here are some of the key changes to the drug registration process in Brazil:
The PMA dossier is now a single document that includes all of the information that ANVISA needs to assess the drug's safety, efficacy, and quality.
ANVISA publishes all of the PMA dossiers on its website, which allows the public to see the information that ANVISA is considering when making a decision about a drug's registration.
The process for submitting a PMA dossier has been simplified.
The time it takes for ANVISA to review a PMA dossier has been reduced.
The new drug registration process in Brazil is a welcome change that will help to ensure that safe and effective drugs are available to Brazilian patients more quickly.
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