There are many doubts about regulating drugs with ANVISA, as this can be a very bureaucratic process due to the characteristics of this product. By dealing directly with people's health and well-being, many stages and stages of regularization require attention and knowledge in the process.
However, following all the requirements imposed by the Brazilian Health Regulatory Agency (ANVISA) there is a guarantee that your company and its product will act in the safety compliances for the final consumers.
Stone Okamont uses your regulatory expertise to help you regulate ANVISA with excellence! Check out how our highly specialized consultants can help you!
Any substance or active principle that has a drug or therapeutic claim.
Before starting to regulate drugs with ANVISA, it is important to know that your company needs other regulations.
The Operating License is the first document necessary to regulate drugs with ANVISA. Its attainment means that the place of business of the company is able to manufacture or distribute the products.
The Operation Permits (AFE) is the documentation that indicates the regularization of the company with ANVISA, enabling the marketing of drugs within Brazilian legislation.
In addition to the License and Permits, the category of medicines involves special documentation in its regularization.
Special Authorization is required for the manufacture or distribution of drugs that are in the controlled category. Some examples:
For the manufacture and storage of medicines, the company must have two certifications.
The Certification of Good Manufacturing Practices comes from the detailed analysis of the Quality System implemented by the company.
Its procurement is necessary for the manufacture of medicines and consequently for its registration.
Many drugs have characteristics that require greater attention in their storage or distribution.
Therefore, it is also necessary to obtain the Certification of Good Practices of Distribution and Storage.
This document is the guarantee that the company follows the necessary norms so that the medicine does not lose its effectiveness during the process of storage or distribution.
For the regulation of similar drugs with ANVISA, the product must have the same active principle, pharmaceutical form, route of administration and posology of the reference medicine.
They may differ in size, form, expiration date or labeling. They must always be identified by trade name or brand.
A drug can be registered as generic if it presents the same active principle, same concentration, pharmaceutical form or indication compared to the reference medicine.
Therefore, for the regulation of the generic drug with ANVISA, it is necessary to carry out bioavailability studies and bioequivalence studies in comparison to the reference medicine.
If the active substance has not yet been registered in the same concentration, pharmaceutical form or indication a Research and Development (R & D) process is required.
This process consists of the synthesis of the molecule, pharmacotechnical development and pre-clinical studies in animals.
With the obtaining of reliable data that prove its safety and efficacy, the clinical studies in humans must be carried out, taking into consideration all the ethical questions involved.
All data obtained must be submitted for analysis by ANVISA.
ANVISA performs a safety, efficacy and quality analysis of the drug before releasing the registry.
Its objective is to ensure that the population is not exposed to dangerous situations and that it has a quality treatment as described by the medicine.
The registration can take around 12 to 15 months to be released and has a duration of 5 years.
Stone Okamont performs a personalized service, applying the Zero Bureaucracy method and guaranteeing satisfactory results and reduced expenses.
If you have questions about registering drug with ANVISA, our experienced consultants are ready to direct the processes and guarantee the success of your company.
We deliver results with agility and we develop intelligent solutions for your business.