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ANVISA has incorporated artificial intelligence (AI) into its framework to optimize the examination of impurity qualification in medications as part of an effort to improve regulatory procedures. By expediting the assessment of contaminants and degradation products, this artificial intelligence technology helps with the examination of pharmaceutical registration and post-registration procedures. ANVISA can expedite the evaluation process by using AI to detect recurrent contaminants from earlier analyses, guaranteeing that safer medications reach the market sooner.

Principal Aims of the AI Tool:

  1. Enhanced Efficiency: AI speeds up regulatory approvals by accelerating the evaluation process for contaminants in new, innovative, generic, and similar medications.
  2. Data-Driven Insights: By using AI, ANVISA can better organize and evaluate impurity data, which enhances regulatory decision-making.
  3. Support for Modernization: The tool helps ANVISA stay current with scientific developments, which makes it possible to approve health products more quickly and with more accuracy.

The advantages of integrating AI include:

Faster Reviews: AI speeds up approval processes by automating repetitive duties like detecting contaminants that have already been examined.

Data Structuring: AI helps ANVISA make decisions on drug registration by arranging impurity data to provide it more lucid insights.

The AI technology guarantees more accuracy in impurity analysis, resulting in safer and more dependable medications.

Collaborative Approach:

By enhancing the way impurity qualification is managed across many medication categories, AI integration enhances ANVISA's current regulatory procedures. This cooperative strategy guarantees that AI is applied in conjunction with professional assessments, resulting in a dependable and effective process.

The Impact on Companies:

The AI technology will speed up the evaluation of impurity qualification studies for businesses proposing new medication qualifications. Future filings will benefit from this cutting-edge technology, but existing ones won't need to be addressed right now. To improve overall market entry timelines for pharmaceutical products, ANVISA anticipates finishing or greatly speeding up the analysis of impurity qualifications. 

This AI approach guarantees quicker and more accurate medication evaluations, which is consistent with ANVISA's mission to improve regulatory efficiency while protecting public health.

Are You Interested in Entering the Brazilian Market?

Freyr can guide you through the AI-powered drug analysis procedure used by ANVISA. Get in touch with us right now to take advantage of our regulatory compliance experience and hasten your Brazilian market debut.