Overview
The stability of medicines is one of the fundamental pillars to ensure their efficacy, safety, and quality throughout their shelf life. In this context, forced degradation studies are essential tools for drug development and stability assessment. Recently, Anvisa published new guidance establishing clear directives for conducting these studies in Brazil, providing greater consistency and transparency for the pharmaceutical industry.
Introduction
Forced degradation studies involve subjecting active pharmaceutical ingredients (APIs) and finished products to extreme conditions (such as light, heat, humidity, pH, and oxidation) to identify possible degradation products. This data is critical to define degradation pathways, validate analytical methods, and support the development of more stable formulations.
The new guide published by Anvisa includes detailed recommendations on:
· Selection criteria for stress conditions;
· Suggested time and temperature ranges;
· Evaluation of relevant degradation products;
· Requirements for data submission in regulatory filings.
What’s New in Brazil and Regulatory Implications
This guidance marks a major step in aligning Brazil with international best practices, such as those outlined by the International Council for Harmonization (ICH). For the industry, it brings greater predictability in registration and post-registration processes, helping to reduce rework and regulatory queries.
From a regulatory standpoint, the guide highlights the importance of properly conducted stability studies and provides more certainty for both regulators and marketing authorization holders. Ultimately, this contributes to the improved quality of medicines available on the Brazilian market.
Conclusion
With the publication of its forced degradation guidance, Anvisa reinforces its commitment to the safety and quality of medicines, while offering greater clarity for companies in the pharmaceutical sector.
At GRP Brazil, we provide full technical and regulatory support for conducting and submitting stability studies, as well as for the registration of medicines with Anvisa. Count on us for effective solutions in registration, regulatory compliance, and issue resolution.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
 Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.Â