Conducting a clinical study, or submitting drugs for registration in Brazil, are some of the topics that can raise doubts that often lead to a search for information at the National Health Surveillance Agency (ANVISA). However, due to its extensive workload, ANVISA provides in-person or virtual assistance only in situations where this is absolutely necessary.
The Agency issued Ordinance Nº54 on January 29, 2021, outlining procedures for requesting and conducting face-to-face or virtual hearings, through the Parlatório System, with a focus on optimizing technical assistance during meetings.
This ordinance makes it clear that the purpose of the hearings is to clarify matters that, due to their complexity, cannot be resolved through the service channels established and published on ANVISA´s electronic portal. Therefore, the first step for clarifying doubts is to contact the Call Center.
By ordinance, a meeting should only be scheduled when the request is accompanied by a detailed agenda, which contains clear and objective questions regarding the object to be addressed.
“ANVISA does not act as an advisory body. Therefore, when attempting to schedule a meeting, such as for a clinical study, it is necessary to demonstrate details of the study project so that the technicians can evaluate the research protocol based on robust information that contributes to the proper evaluation. It´s important to keep in mind that every question should be accompanied by a well-prepared proposal to demonstrate to ANVISA that the presented rationale is the most suitable for the project”, explains Claudia Cilento, Partner-Director at the consultancy Inovatie Health Services, responsible for the Regulatory Affairs department. She is also a professor of postgraduate courses in Sanitary Regulatory Law and Regulatory Affairs of Medicines and Cosmetics at Faculdade Oswaldo Cruz.
She also states that ANVISA schedules meetings only in very specific cases where the interested party has made it clear that the meeting is necessary and essential. “There must be a compelling reason for scheduling the meeting. A simple request from the company is not sufficient.Therefore, the recommendation is to provide a clear and detailed explanation of why this meeting is essential”, she emphasizes.
Therefore, it is important that the appointment request contains:
• Presentation or material that will be discussed in a meeting.
• Brief summary of the proposed project or plan.
• List of preliminary questions to be addressed during the meeting.
• Previous minutes, in case the matter has already been the subject of a hearing.
Meetings that aim to deal with matters related to petitions already submitted to ANVISA will only be scheduled if the applicant has contacted one or more service channels and has not yet clarified his doubts, in this case, you must provide the complete agenda description, including at least the following information:
• Case number and file that will be the subject of the hearing.
• Number of the protocol opened in the service channels, accompanied by a justification containing the reasons why the response sent was insufficient to address the question asked.
• Technical requirement notification number.
For each requirement item to be discussed, provide the following information:
1. The item number.
2. The specific question regarding this item.
3. If the company has understanding on the subject, detail this understanding and insert justification or technical-scientific basis.
4. If the company has a proposal for compliance with the item, detail this proposal and insert justification or technical-scientific basis.
5. Minutes of previous hearings, if available.
Meetings requested to verify the status of the process or to clarify other doubts will not be scheduled if the matter can be clarified by the Agency's Call Center.