Regulation of Pharmaceuticals in Brazil by ANVISA
- Artixio Consulting
- Jan 12, 2022
- 5 min read
Updated: Mar 4
Brazil is the largest pharmaceutical market in South America with a CAGR of 10.6%. With the rise in globalization, pharmaceutical companies are keen on launching their products in the Brazilian market. Though the market it has established regulatory system yet it’s highly complex. In order to register a product in Brazil, one needs approvals from The Agência Nacional de Vigilância Sanitária (ANVISA) under the Ministry of Health, which accepts the dossier in eCTD format.
ANVISA: An Overview
Agência Nacional de Vigilância Sanitária (ANVISA) is the Brazilian Health Regulatory Authority. It was created in 1999 with a goal to promote and protect the public health by implementing health surveillance of products and services in Brazil. Apart from this, to intervene in the risks that are caused due to production or use of products which are regulated by health surveillance is also the mission of ANVISA.
As per the objective of extension of global outreach, ANVISA was welcomed as a new member into the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in November 2016. ANVISA has control over a wide diversity of health related areas which includes pharmaceuticals, medical devices, food, health services, coordination of Brazilian Health surveillance system, Pharmacovigilance, etc.
Categorisation of Pharmaceuticals in Brazil by ANVISA
The ANVISA categorizes the drugs into :
New synthetic and semi-syntheric drugs
Generic drugs
Similar drugs (branded generics)
Potentized medicines (homeopathic, anthroposophic and antihomotoxic)
Specific medicines
Notified medicines (low risk)
OTC (over the counter) drugs
Herbal medicines
Medicinal gases
Biologic products
Radiopharmaceuticals
Key Regulation of Pharmaceuticals in Brazil by ANVISA
Pharmaceutical or Submission Category | ANVISA Regulations |
New synthetic and semi-synthetic drugs | |
Generic drugs | |
Similar drugs | |
Potentized medicines | |
Specific medicines | |
Notified medicines | |
OTC drugs | |
Herbal medicines | |
Medicinal gases | |
Biologic products | |
Radiopharmaceuticals | |
Clinical trials with drugs and biological products |
|
Marketing Authorization |
|
Post-marketing Variations |
|
Registration of Pharmaceuticals in Brazil with ANVISA
The registration of pharmaceuticals in Brazil can be initiated by the local company legally constituted in Brazil. The foreign manufacturers shall appoint a local representative for the registration of their pharmaceuticals with ANVISA, Brazil. For product commercialization in Brazil, the following registration process needs to be followed:
Preparation of registration dossier for ANVISA: Preparation of dossiers to be compliant to ANVISA guidelines
Submission of documents to ANVISA: Once the documents are prepared, the submission process needs to be initiated.
GMP Inspection by ANVISA: Further, health authority inspectors would carry on GMP inspections of the manufacturing sites
Local product testing: The products need to be tested locally within Brazil
ANVISA Drugs Registration Process is as follows:
Submission of Application dossier to ANVISA
Review of safety, efficacy data as provided by applicants in the modules by Office for New Drugs, Research and Clinical Trials (GEPEC)
Chamber of Drug Market Regulation discusses with the applicants regarding the pricing points for their products
GMP inspections of the manufacturing facilities are carried out by ANVISA
Post thorough review of the documents submitted and the inspection, the market authorization is granted to the applicant by ANVISA
Essential Documents Needed For Registration (Brazil ANVISA)
Documents needed to initiate the process of submission to health authority is categorized in five modules such as:
Administrative: Includes the administrative and local information and is covered within Module-1
Technical: This includes include summaries of pre-clinical studies, CMC data along with nonclinical and clinical reports and data and is covered within Modules 2, Module 3, Module 4 and Module 5
The list of documents needed to be presented to ANVISA within each module are:
BE Studies
The documents mentioned within five modules are needed for New Drugs whereas for Branded and Non-Branded drugs only documents needs are Module 1 and Module 3. Also, the requirement for BE study document is for Branded and Non-Branded Drugs only.
ANVISA Good Manufacturing Practices (GMP)Â
Like every other regulatory authority, GMP compliance is a mandatory requirement for ANVISA as well. All establishments manufacturing products which are subjected to sanitary surveillance must follow GMP requirements which are either located nationally or abroad.Â
Category | Applicable GMP Regulations |
Drug Products (Medicines)Â | |
Radiopharmaceuticals | Resolution RDC 658/2022 and Normative Instruction - IN 128/2022 |
Active Pharmaceutical Ingredients (APIs)Â | |
Medicinal Gases |  Normative Instruction - IN 129/2022 and Resolution RDC 658/2022  |
Pharmaceutical Excipients  | |
Herbal Products |  Normative Instruction - IN 130/2022 Resolution RDC 658/2022  |
Cosmetics, Fragrances and Personal Hygiene products | |
Sanitizers |
Process of GMP inspection by ANVISA:
Requirement for completed, stamped and signed petition form
Valid GMP certificate issued by the health authority of the country of origin (Certificates issued in English or Spanish is accepted; no need for translation)
Plant Master File - AMP or Site Master File – SMF
Periodical Product Review (RPP)
Inspection Report from other health authorities in country of origin if available
Regulatory Review Timelines for ANVISA:
GMP Inspection: ANVISA can inspect a manufacturing site anywhere around 6 months from the submission of request for inspection. Post inspection ANVISA takes around 45-60 days to issue the GMP certificate
Registration Process: The Standard review process generally takes 365 days for registration and 180 days for Post approval changes whereas the priority review process takes anywhere around 120 days for registration and 60 days for Post approval changes.
One of the main challenges, mostly applicable to the foreign manufacturers, to be faced while marketing a drug in Brazil is understanding the requirements set forth by the regulatory body. Although it is defined what must be needed in their official website, not everything translates to English, most of them are in Portuguese. This can be a challenge, but it can be solved by appointing a local representative which also favours when there is a need to communicate with ANVISA.
At Artixio, we have a team of experts who understand the Brazilian market and comes with decades of experience working with the authorities in Brazil. Our team has helped numerous pharmaceutical companies complying to ANVISA’s regulatory needs. Our experts have expertise in providing end to end solution for Brazilian registration requirements:
Preparation and submission of dossier, complying to necessary guidelines to ensure a smooth process of submission for medicinal products
We have a team of consultants who have experiences handling GMP audits for manufacturing sites updating system as per GMP requirements
Artixio team can partner as your authorized legal representative for Brazil helping with health authority (ANVISA) communication on a regular basis
We have our partners who can also assist you with local clinical and non-Clinical testing of your products at ISO compliant laboratories.
Our team would be happy to assist you with your requirements for Medicinal/ Pharmaceutical Product registrations in Brazil.
FAQ’s
What does ANVISA expand to?
ANVISA expand to Agência Nacional de Vigilância Sanitária which translates to National Health Surveillance Agency in English.
What is the timeline for reviewing category I and category II medicines by ANVISA?
The timeline for conducting review for category I medicines are 120 days, and it is 365 days for category II. Category I are priority drugs and category II are ordinary medicines.
What are the institutions involved in clinical trials and approval processes?
The 3 different institutions involved in the clinical trials and approval processes are ANVISA, CONEP (Comissão Nacional de Ética em Pesquisa) and CEP (Comitê de Ética em Pesquisa).
What are CONEP and CEP?
CONEP (Comissão Nacional de Ética em Pesquisa which translates to National Committee of Ethics in Research) is the Central Ethics Committee that is responsible for the ethical aspects of clinical trials in Brazil. CEP (Comitê de Ética em Pesquisa which translates to the Committee of Ethics in Research) is the local ethics committee, which is registered under CONEP, the central one. CEP reviews and approves the clinical trials that are conducted in an institution.