ANVISA Resolution No. 964 was published in the Federal Official Gazette (DOU) on February 24, 2025, establishing general requirements for conducting Forced Degradation Studies on medicines containing synthetic and semi-synthetic active pharmaceutical ingredients (APIs).
The resolution also defines the parameters for the notification, identification and qualification of degradation products in these drugs. Below, we summarize the most important points of this new regulation.
Resolution’s goal
The main objective of ANVISA Resolution No. 964/2025 is to define the guidelines for carrying out Forced Degradation Studies on medicines.
These studies are essential to guarantee the stability of medicines, assessing the formation of degradation products that could impact the safety and efficacy of the product over time.
Medicines covered
The resolution applies exclusively to medicines containing synthetic and/or semi-synthetic active pharmaceutical ingredients in their composition, including when associated with other APIs.
In combined medicines’ case, the resolution’s criteria should only be applied to the synthetic and semi-synthetic APIs present in the formula.
Exceptions to Applicability
The resolution does not apply to:
- Isolated APIs;
- Isolated excipients;
- Medicines used in the development stages of clinical studies;
- Medicines containing biological/biotechnological APIs, peptides, oligonucleotides, vitamins, minerals, amino acids, proteins, inorganic compounds, among other atypical APIs or those derived from fermentation.
Repeal of previous resolutions
The new resolution repeals the following previous resolutions:
- RDC No. 53, of December 4, 2015;
- RDC no. 171, of August 22, 2017.
Date of Entry into Force
ANVISA Resolution No. 964/2025 comes into force on the date of its publication, i.e. February 24, 2025.
Recommended reading
It also recommend to read the Vote No. 47/2025/SEI/DIRE4/Anvisa, which was issued during the 2nd Ordinary Public Meeting of Dicol – 2025, held on February 19, 2025. This vote offers a detailed explanation and contextualization of the resolution.
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