Overview:
Before reaching the Brazilian consumer market, it is necessary that a drug has its quality, safety, and therapeutic efficacy evaluated by the National Health Surveillance Agency (ANVISA). This happens through the registration process, which is sent to the regulatory agency by a company in the pharmaceutical sector, with duly authorized activity. This administrative instrument is of great importance for health surveillance, and the quality of the products marketed in the country depends on its performance.
Introduction:
In Brazil, the requirement for drug registration is foreseen in Law 6.360, 1976. This law also establishes the deadlines for ANVISA to issue a final decision on the registration process, taking into account the technical complexity and the clinical, economic, and social benefits of using the drug that is the subject of the application. Since March 29, 2017, when Law No. 13,411 of 2016 came into effect, the deadlines for decisions on registration processes are divided according to the classification of the drug in two evaluation categories: priority and ordinary (non-priority).
The Management of Technology Evaluation for Registration of Synthetic Drugs (GRMED).
Is responsible for the evaluation of pharmaceutical technology (quality) for granting the sanitary registration of generic, similar, new and innovative drugs.
The subject code, at the time of electronic submission, must be chosen at Anvisa’s portal (http://portal.anvisa.gov.br/sistema-consulta-de-assuntos) according to the category of product to be submitted (generic, similar, new and/or innovative).
For the prioritization of a registration process, the public relevance of the drug is taken into consideration. The prioritization criteria used by ANVISA are set out in RDC No. 204 of 2017.
Who can use this service?
The registration of generic, similar, new and/or innovative drugs can only be performed by companies legally licensed by the state and/or municipal sanitary level and authorized by the federal level as drug manufacturers.
In the case of imported drugs, the importer must be legally licensed and authorized for this purpose.
In addition to holding the health license and the operating authorization, the company must be correctly registered in Anvisa’s electronic petition system in order to submit the registration.
Steps to accomplish the registration at Anvisa
- Submit the petition at Anvisa’s portal: Sanitary Surveillance and Inspection Fee The value is regulated by law and varies according to the type of sanitary registration required and the economic size of the company.
- Submit the documents required by the instruction checklist of the respective subject code to the chosen petition: The same must be instructed and filed as a process at the Gerência de Gestão de Gestão Documental e Memória Corporativa – GEDOC, at Anvisa’s headquarters.
- Follow up on the progress of the process: Follow the progress of the analysis status of processes filed with Anvisa at the Anvisa portal
Channel of service provision: Web : Access Anvisa website.
DURATION OF THE STAGE: Not estimated yet
Other Information
How long does it take?
Between 120 and 365 calendar days is the estimated time for this service to be provided.
Additional information to the estimated time
- Priority = 120 days, counted from the prioritization date;
- Ordinary (non-priority) = 365 days, counted from the date of the registration process protocol.
In both evaluation categories, the period can be extended by up to one third of the original period, a single time, by means of a reasoned decision by ANVISA.
Legislation
For the prioritization of a registration process, the public relevance of the drug is taken into consideration. The prioritization criteria used by ANVISA are set out in RDC No. 204 of 2017.
For more information or questions about this service, please contact: Global Regulatory Partners Brazil and we will help you
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References
Brazilian Health Surveillance Agency – ANVISA
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, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.