BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
First instance appeals are directed against deci- sions issued by ANVISA’s Organisational Units and must be addressed to the authority respon- sible. If unresolved initially, appeals are reviewed by the General Appeals Management at the sec- ond stage and, if necessary, escalated to the Appeals Division (GGREC) and ultimately to the Collegiate Board of Directors (DICOL). Appeals must adhere to formal requirements outlined in RDC 266/2019, Article 4 onwards, and must be submitted in writing. The deadline for appealing an ANVISA decision is 30 days from the notification date. Similar challenges can be applied to other regu- latory matters under ANVISA’s jurisdiction, such as food, cosmetics, sanitisers and tobacco derivatives. 1.3 Different Categories of Pharmaceuticals and Medical Devices ANVISA categorises pharmaceutical products based on their active pharmaceutical ingredient (API) and innovative characteristics as outlined in RDC 753/2022, amended by RDC 948/2024, as can be seen below: Pharmaceutical Categorisation (RDC 753/2022) Primarily, but not exclusively: • reference drug – an original, rigorously tested drug approved by ANVISA; • generic drug – a cost-effective alternative drug with the same ingredients, form and effect; • innovative drug – a drug that features new molecules, combinations or delivery methods; • new drug – a drug that contains previously unapproved molecules; and
• similar drug – a drug that is similar to a refer- ence drug with minor variations. Medical Device Categorisation (RDC 751/2022 – amended by RDC 777/2023 and 810/2023) Categorised by use and risk: • active medical device – operates with exter- nal energy, alters density of gravity or con- verts energy; • diagnostic and monitoring device – provides information on health states; • therapeutic device – modifies, replaces or restores biological functions; • single-use device – used once per procedure; • implantable device – fully or partially inserted into the body; • invasive device – partially or fully penetrates the body; and • in vitro diagnostic device – analyses samples for diagnostic purposes.
Risk Classification • Class I – low risk;
• Class II – medium risk; • Class III – high risk; and • Class IV– maximum risk.
2. Clinical Trials 2.1 Regulation of Clinical Trials Clinical Trials for Pharmaceuticals
• RDC 945/2024 establishes the guidelines and procedures for conducting clinical trials in the country with the aim of subsequently granting drug registration. • CNS Resolution 251/1997 defines regulatory and bioethical guidelines. • CNS Resolution 466/2012 establishes general rules for clinical trials.
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