Anvisa published, on August 19, Service Guidance n. 70/2019 (Orientação de Serviço - OS n. 70/2019), which establishes and optimizes the work process related to the analysis of efficacy and safety of synthetic and semi-synthetic drugs classified as new and innovative. The OS, applicable to registration and post-approval petitions, determines that data review should follow the guidelines of the Synthetic Drug Evaluation and Effectiveness Review Roadmap (or Roteiro de Análise de Eficácia e Segurança para Avaliação de Medicamento Sintético).
The document provides for the possibility of using analysis reports from the Food and Drug Administration (FDA), and the European Medicines Agency (EMA), at efficacy and safety data evaluation process for the registration of these drugs.
Using FDA and EMA analysis reports in the evaluation process will provide further input to Anvisa's decision-making process. These regulatory agencies follow international quality standards and are part of the International Council for the Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH), of which Brazil is also a member.
In cases where FDA and EMA review opinions are used, Anvisa will establish the benefit/risk balance of the drug for Brazilians and the information related to the efficacy and safety data to be included in the drug package insert. Brazilian population and current sanitary regulations. Similarly, the final regulatory decision on an application for registration or post-registration change of drug is the Agency.
The optimization is part of a series of measures implemented by Anvisa to comply with the registration and post-registration change deadlines for priority and ordinary drugs established by Law 13,411 / 2016 and the deadlines for registration of new rare disease drugs, according to Resolution of the Collegiate Board (RDC) 205/2017.
Regulatory agencies such as Canada and Singapore currently use FDA and EMA analysis reports.
Efficacy and safety analysis
One of the prerogatives for the registration of medicines, as provided in Law 6.360 / 1976, is that the product is recognized, through scientific proof, as safe and effective for its intended use. That is, a drug must be subjected to several types of research that demonstrate the efficacy and safety of its use in humans. The scientific data obtained during the research are presented in the drug registration process and used by Anvisa for efficacy and safety analysis.
Some historical events demonstrate the importance of efficacy and safety analysis during the drug registration process. One such event is the case of thalidomide. The drug was launched in the market in 1956 after limited evaluations and the absence of consistent data analysis mechanisms. A few years later, there was an increase in the number of serious fetal malformations associated with the use of the drug by pregnant women.
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