Advanced Therapy Products are products of biological origin obtained from human cells and tissues that undergo a manufacturing process.
Advanced Therapy products are a hope for treating complex diseases with no treatments available. However, Advanced Therapy Products have a high degree of complexity in terms of proof of efficacy, safety and stability.
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Advanced Therapy products are registered by Anvisa (National Health Surveillance Agency) as a biological medicine. To register Advanced Therapy Products in Brazil it is necessary to obtain the Certification of Good Practices. CGMP is mandatory for companies that work with: Medicines and products rated between III - High risk and IV - Maximum risk. It is a set of rules established by Anvisa in order to standardize the processes that involve the product.
Anvisa is a Brazilian agency responsible for regulating products: correlates, cosmetics, medicines and others.
Do you know what it takes to register Advanced Therapy Products in Brazil? In this content we will bring all the necessary regulatory steps to Register Advanced Therapy Products in Brazil. Check it out!
What do I need to register Advanced Therapy Products in Brazil?
To register Advanced Therapy Products in Brazil, it is first necessary that the company is properly regularized, this regularization is done in three stages. (See below for how to get it).
Company regularization
To register Advanced Therapy Products in Brazil the company will need to follow the following steps:
Establishment of a company: The initial stage for the regularization of a company consists of establishing a physical location in Brazil, following all the criteria required by VISA and Anvisa.
Operating License: This step is carried out with VISA (Local Health Surveillance) of your municipality or state. At this stage, the company must adapt its physical structure in order to receive an inspection conducted by a VISA inspection agent. The adequacy must be based on the RDC (Resolution of the Collegiate Board) corresponding to the activity performed by the company.
Operating Permits: This step is the last step necessary to regularize the company. The process goes to the federal level being protocoled in Brasilia, and the entire regulatory analysis will be carried out by Anvisa agents. Compilations of documents, collection of fees and verification of petitions are some of the actions that occur in this process.
After regularizing the company, to register Advanced Therapy Products in Brazil, it is necessary present to Anvisa tests that prove product safety, efficacy and stability, which for biological products can be a great challenge. In addition, information more specific to the type of product will be requested according to its function. There are a variety of biological products and various applications, the tests will be performing in accordance with the functionality of each type. Learn more: Product registration.
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Register Advanced Therapy Products in Brazil is a very complex technical process that requires knowledge and expertise from a competent adviser to assist in all regulatory steps. Stone Okamont is the right advisor for your business!
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