BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
classification of medical devices as any instru- ment, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article, intended by the manufacturer to be used, alone or in combination, in human beings, for some specific medical purpose, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action. For a product to be classified as a pharmaceuti- cal (regarding Law 10,742/2003), it should be any pharmaceutical product, technically obtained or prepared, for prophylactic, curative, palliative or diagnostic purposes. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Biologic products often involve complex manu- facturing processes and unique safety consid- erations compared to traditional chemical drugs. Therefore, obtaining marketing authorisation for biologics in Brazil typically involves additional requirements beyond those for chemical drugs. Comprehensive Dossier Detailed information about the biologic product must be submitted to ANVISA. This dossier typi- cally includes: • product characteristics; • manufacturing information; • non-clinical studies – data from pre-clinical studies (in vitro and in vivo) assessing the product’s safety and potential efficacy; • clinical studies – data from well-designed and controlled clinical trials in humans to demon- strate the product’s safety and efficacy for the intended use; and • risk management plan – a comprehensive plan outlining potential risks associated with
the product and strategies to mitigate those risks. Comparability Studies For biosimilars (biologics that are similar to an already approved reference product), additional comparability studies demonstrating similarity to the reference product in terms of quality, safety and efficacy are often required. Stricter Regulatory Requirements Compared to chemical drugs, biologics might face stricter regulatory requirements related to manufacturing process controls, product char- acterisation and ongoing monitoring of safety post-marketing. Additional Considerations • Foreign clinical trials – clinical trials con- ducted outside Brazil might be accepted by ANVISA under certain conditions. However, specific requirements regarding data integrity and compliance with Good Clinical Practices must be met. • Post-marketing surveillance – marketing authorisation holders are typically required to conduct post-marketing surveillance to moni- tor the safety and efficacy of their biologic product in the real-world setting. The following are some of the main resolutions that relate to biological products. • RDC 55/2010 (in force but amended by RDC 948/2024) regulates the registration of new biological products and biological products. • RDC 913/2024 regulates post-registration changes and cancellation of registration of biological products. • RDC 412/2020 establishes the requirements and conditions for conducting stability stud-
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