Overview
In Brazil, clinical trials for drugs follow strict regulations, guaranteeing the safety of participants and the efficacy of the drugs being tested. The regulatory body responsible is the National Health Surveillance Agency (ANVISA), which establishes rules for conducting these studies.
Introduction
Clinical trials for medicines in Brazil are studies carried out on human beings with the aim of assessing the safety, efficacy and quality of new drugs or therapies. These trials are essential for the development of new drugs and follow strict regulatory guidelines established by the National Health Surveillance Agency (ANVISA) and other ethical control bodies, such as the Research Ethics Committees (CEPs) and the National Research Ethics Commission (CONEP).
Main stages and regulations for conducting clinical trials in Brazil:
- Ethical Submission and Approval:
- Every clinical trial must be approved by a Research Ethics Committee (CEP) accredited by the National Research Ethics Commission. (CONEP).
- Submission to CEP/CONEP involves analyzing the study protocol, including the informed consent form (ICF), to ensure the protection of the rights and well-being of the participants.
- Submission to ANVISA:
- After ethical approval, the sponsor must request the Clinical Trial Authorization (AEC) from ANVISA.
The process involves submitting a dossier containing:
- Study protocol.
- Information on the drug being tested (including pre-clinical and clinical safety data).
- Manufacturing and quality control data.
- Information on the research centers and investigators responsible.
- Regulatory Resolutions and Standards:
The conduct of clinical trials is mainly regulated by the following resolutions and guidelines:
- Resolution RDC 9/2015: Establishes the requirements for conducting clinical trials with medicines in Brazil, including aspects of submission, monitoring and the responsibilities of sponsors and researchers.
- Resolution CNS 466/2012: Defines guidelines and regulatory standards for research involving human beings, addressing ethical aspects, the rights of participants and procedures for approval by ethics committees.
- Resolution RDC 205/2017: Regulates the use of new medicines under special conditions and expanded access, also applicable to clinical trials of innovative medicines.
- Resolution RDC 55/2010: Focuses on clinical trials of biological products.
- Phases of Clinical Trials:
Clinical trials follow a phased process:
- Phase 1: Initial safety study involving a small number of healthy volunteers.
- Phase 2: Evaluation of preliminary efficacy and safety in patients with the target condition.
- Phase 3: Large-scale trials to confirm efficacy and monitor adverse effects.
- Phase 4: Post-marketing studies to assess long-term safety and efficacy in larger populations.
- Time and costs
The submission process to ANVISA can take 90 days or more to be evaluated, depending on the complexity of the study and compliance with regulatory requirements.
Costs vary according to the number of research centers, the type of drug, the phases of the study and the administrative costs involved.
Electronic Platforms and Processes:
- The documents for clinical trial authorization are submitted through ANVISA’s e-CAC system, where the sponsor can monitor the status of the process.
- The Clinical Trials Registration System (ReBEC) is the platform where clinical trials must be publicly registered, increasing the transparency of research conducted in Brazil. These clinical trials are essential for the approval of new drugs in the country, following a strict scientific and regulatory protocol to guarantee efficacy and safety for patients.
- Resolution 9/2015 applies to all clinical trials with drugs that will have all or part of their clinical development in Brazil for registration purposes.
Clinical trials with medicines registered in Brazil must follow all the provisions of this RDC 9/2015 when they provide subsidies for:
- new therapeutic indication;
- new route of administration;
- new concentration;
- new pharmaceutical form;
- expanded use;
- new posology;
- new associations; or
- any post-registration change requiring clinical data, including registration renewal.
Post-marketing clinical trials (phase IV) are not the primary object of the RDC 9/2015 standard and are only subject to the Clinical Trial Notification and should only be started after obtaining ethical approvals in accordance with current legislation.
In the case of phase IV clinical trials where the drug already has a Clinical Drug Development Dossier (DDCM) approved by Anvisa, the Notification application must be linked to the DDCM;
Phase IV and observational clinical trials that are not part of a previously approved DDCM and involve import or export procedures, will be subject to Clinical Trial Notification and issuance of a Special Specific Notice (CEE) within 30 (thirty) calendar days from the date of receipt of the notification by Anvisa.
The Clinical Trial Notification must consist of the following documents:
- a) Completed clinical trial submission form, available on Anvisa’s website;
- b) Proof of payment of, or exemption from, the Sanitary Surveillance Inspection Fee, by means of a Federal Tax Collection Form. (GRU);
- c) Clinical trial protocol in accordance with BPC;
- d) Proof of registration of the clinical trial in the registration database of the International Clinical Trials Registration Platform / World Health Organization (ICTRP/WHO) or others recognized by the International Committee of Medical Journals Editors (ICMJE);
Conclusion
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.