BRA. Anvisa moves forward with regulatory methods
25 octubre 2017

The Brazilian National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria or Anvisa) introduced the guidelines for the regulatory enhancements it is implementing pursuant to recommendations made by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use or ICH. The presentation, which took place in Brasilia, provided the framework to present the entity’s activities to the International Council meeting, which will be held in Geneva, Switzerland November 11-16, 2017.

At the meeting in Brasilia, various Anvisa subdivisions presented the advances made by each administrative section to standardize the regulatory processes recommended by the Council. It is anticipated that these processes will be in alignment with the international guidelines by November 2018.

The first part of the meeting consisted of a debate on the topics to be explored at the ICH meeting. Anvisa’s General Office on Drugs and Biological Products (Gerencia General de Medicamentos y Productos Biológicos or GGMED) addressed the aspects involved in the process for crafting the Council’s regulations and provided updates on each working group’s activities with Anvisa.

The General Office on Health Surveillance Product Tracking (Gerencia General de Monitoreo de Productos Sujetos a la Vigilancia Sanitaria or GGMON) presented a flowchart established by the agency for the incorporation of pharmacovigilance standards, which is expected to take place in November 2018. The General Office on Legislation and Good Regulatory Practices (Gerencia General de Reglamentación y Buenas Prácticas Regulatorias or GGREG) made information available regarding the regional consultation process promoted by the ICH, using the Limesurvey participation tool to present the provisional flowchart adopted by Anvisa for the public hearings that have already taken place.

During the second part of the meeting, representatives from the Department of International Business within the Ministry of Industry, Foreign Commerce and Services presented preliminary information on technical barriers to the new information system. The product will be a private sector support tool for providing communication regarding obstacles to commerce identified within the exportation process. The launch of the system is scheduled to take place during the last quarter of 2017 and will be accompanied by national government disclosures.