On March 22, 2016, the Brazilian Health Authority (ANVISA) approved the amendments of Regulation RDC 48/2009, which refers to the post-approval changes of drug products. The amendments establish a new regulatory framework for post-approval changes through the incorporation of different risk analysis depending on the complexity and the health risk of the modified drugs.
Law 6.360 / 1976 establishes that products subject to health surveillance, such as drug products, cannot be marketed without previous approval by ANVISA, which analyses their safety and efficacy.
However, after approval, it is very common for companies to request amendments to the original features of a drug product at any stage of its life cycle, such as changes in its components and composition, the manufacturing site or the manufacturing process, among others. This post-approval process is also subjected to revision by ANVISA, since the requested modifications can potentially have an adverse effect on the identity, strength, quality, purity, or potency of a drug product, which may affect its safety or effectiveness.
It is expected that the new regulations will impact the number of post-approval requests currently pending in ANVISA, since they establish different types of analysis depending on the health risk that a post-approval change involves. Accordingly, ANVISA will focus on the analysis of post-approval changes that involve moderate or high health risks, whereas the approval of those having a lower health risk will be faster.
Originally published on 22 Apr 2016
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