Análise das exigências de segurança e eficácia de medicamentos sintéticos no Brasil em 2023

Introduction: In Brazil, a drug must be registered with the Brazilian Health Surveillance Agency (ANVISA) before it can be marketed. The registration application process requires the submission of safety, efficacy, and quality data. Compliance with all requirements is essential for registration review and approval. Objective: To analyze the requirements and reasons forrejection of the safety and efficacy analysis of new and innovative drugs in 2023. Method: Observational, descriptive, and qualitative-quantitative study of new and innovative drugs in 2023. Data collection was carried out from primary sources through technical rejection reports and requirement item reports contained in DATAVISA. Results: Sixty-eight publicationsrelated to new and innovative drug registrations were found in the Official Government Gazette. Of these, four (5.88%) drugs were rejected by Anvisa: three rejections related to new drugs and one rejection of an innovative drug. Two registrations were rejected due to safety and efficacy concerns. Furthermore, 1,374 technical requirements for registration and 358 technical requirements related to post-registration petitions were issued. Conclusion: The frequency of drugs rejected for safety and efficacy reasons was low. Furthermore, most of the requirements were for medium and low risk. This may be related to the continuous improvement of the Brazilian regulatory process in recent years.