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Atualizado: 6 de fev. de 2020

Who are the main regulators and what are the key legislations that apply to biotechnology & pharmaceuticals?


The main Regulator to apply Biotech pharma in Brazil is Agencia Nacional de Vigilância Sanitaria – Anvisa.

The  biotechnology & pharmaceuticals key regulation in Brazil are: the Brazilian Federal Constitution specially articles 23,30, 196-200, Federal 5.991/73 6.360/76, 6.437/77, 6.938/81, 8.078/90, 9.279/96, 9.456/97, 9.610/98, 9.782/99, 10.196/01, 10.603/02,  11.105/05 ; Decree n. 75.572/75, 02/94,  6.041/07,  2.519/98, 4.074/02, 4.339/02, 4.680/03, 5.591/05, 5.950/06. ANVISA Resolutions: RDC 46/02, 168/2002, 305/02, 323/03, 68/03, 274/0204/05, 233/05, 206/05, 61/08, 55/10, 47/09, 71/09, 49/11, 50/11.

Taking a look at Biotechnology development & approval in the Brazilian market

According with the Brazilian Constitution all Biotechnology & Pharmaceutical regulatory system is based in the principles of “ prevention of harm promotion of benefit” that is, the government must protect the public from products that are unsafe or ineffective.

The Biotechnology & Pharmaceutical Products approval process is applied by a company based in Brazil only, duly authorized by Federal (Anvisa) and local health authorities (sanitary surveillance – municipal and state) to import, distribute and market a Biotechnology pharma product.

In other words, either a company set up its office in the territory or have its product represented by a national distributor.

The Brazilian Biotechnology & Pharmaceutical regulatory System

There are 7 categories of Bio-pharmaceutical products, according with the Brazilian legislation:

  • Vaccines

  1. Hiper-imune serunms

  2. Hemoderatives

  3. Bio drug classified into:

  4. Drugs obtained from biological fluids or tissues of anima origin

  5. Drugs obtained by biotechnological procedures

  6. Monoclodal antibodies

  7. Drugs contained live, attenuated or dead microorganisms

  8. These  products could be classified either “new product” (product under patent protection) or “biossimilar” product (copy of the new product that has no more patent protection).

The essential documents for Biotechnolgy & Pharmaceutical product registration in Brazil are:

a) Application form Anvisa.

b) Proof of the payment of the registration fee..

c) Trade Permit (Alvará de Funcionamento) issued by the State authority in the name of the manufacturer’s distributor.

d) Same type of document (Autorização de Funcionamento), issued by the Federal authority (Anvisa) to the manufacturer’s distributor.

e) Document showing the technical responsibility of the distributor/manufacturer, issued by the certification entity.

f) Technical Report on the product providing information on the formulation, instructions, directions of use  and cautions.

g) Label sample, brochures and pertinent information about the products, all translated into Portuguese.

h) For products not register in Brazilian law, it is mandatory to provide information about their use in order to demonstrate efficacy and safety.

i) Copy of the product registration granted  in the country of origin (or copy of the Certificate of Free Sale).

j) Copy of legal document by which the manufacturer authorizes its distributor to trade and distribute the products.

k) Good Manufacturing Practices Certificate.

l) In the case of a medical equipment, all documents showing product safety, country of origin, comprehensive details of the equipment’s component parts, and the user manual have to be presented for registration.

m) Labels sample

n) clinical trial data

The company, on filing the registration application, must submit one 1 copy of the entire application documentation and one 1  CD-ROM with the same information recorded in electronic language in pdf format (the disc serial number must be explicit in the document).

All documents of Bio-Pharmaceutical process submitted to Anvisa Agency, as well as all information contained in labels, package inserts, packs and all printed material, must be written in Portuguese, meeting the legislation in effect. There are some exceptions in the Brazilian legislation that accept some documents in english or spanish version. However, it is not recommended since it could occurs some mistake in the technical information interpretation just because the document is not in Portuguese version.

Additional Evidences of Identity and Quality of the components of the new Biological Pharmaceutical Product

According with the Brazilian legislation, Anvisa may, at any time and at its sole discretion, demand additional evidences of Identity and quality of the components of the new biological product or biological product, and/or request for new studies to evidence the clinical efficacy and safety, in case of the occurrence of facts that give rise to complementary evaluations, even after granting the registration.

For the imported product, the legislation says that the registration for new biological product or biological product manufactured in other countries may only be granted by Anvisa if the drug is registered and released for use in its manufacturing country, according to the health legislation in effect.

Besides, the Brazilian legislation demands that all therapeutic indications requested in the registration for new Biological product or Biossimilar product must be duly documented in the reports of the clinical studies and it must be approved by the health authority of the country where the clinical research was conducted.

The GMP Process of Biopharmaceutical Product

According with the Brazilian Legislation, all companies involved in the manufacturing of a new biological product or biological product must meet good manufacturing practices, and present the Good Manufacturing Practices Certificate (GMPc) issued by Anvisa.

What are the current market dynamics, policies and strategies in your jurisdiction?

Biotechnology is a trend for the Brazilian Pharmaceutical market. It represents between 10% to 15% of the  market. Their growth is estimated at 80% of the market in the next five years.

According with the pharmaceutical sources,

The Brazilian market imports U$ 1,5 billion of biopharmaceutical products per year and 60% of this value  was  paid by the public system.

The timeframe to launch the biopharmaceutical and biomedical in the Brazilian Market 

The timeframe of a Biopharmaceutical product in the Brazilian was reduced between 180 days to 360 days.

The Brazilian Biopharmaceutical and Biomedical system do not have specific price policy reduction such as for generic product. And the curve of the pharmaceutical policy adoption is much slower since most of the product are directed to the serious illnesses. Besides, there is no fast track for Biopharmaceutical and Biomedical product in the Brazilian regulatory system.


The current market dynamics is focused on three important sectors: “new biopharmaceutical produc”; “biossimilars” (specie de  copy of the new product that is no longer under patent protection)  and the  development of the manufacturers plant (since the market is still missing biotech manufacturers). There are few new biopharmaceutical product (product under patent protection and classified as “reference product”) in the Brazilian market. The country is missing more investments in this field and specifics efforts are been taken by the government. This sector is highly regulated by the Brazilian government.  There are preference for products produced locally and the law says until 25% of the offers made to the public health system must come from local companies.

Have there been any recent regulatory changes or interesting developments?

Nothing specific in these last few years. The only change related with this subject is the recent RDC n.  74/2016 that established new rules for the electronic application process for the imported products.

The opportunities and challenges relating to personalized medicine for Biopharmaceutical and Biomedical products in Brazil

Acrucial issue for Biopharmaceutical and Biomedical product in the Brazilian System is the reimbursement system.

The government  is the most important player in the Brazilian health system and to sell  a product to the government under the reimbursement system is not clear enough. Besides, there are some gaps in the  rules of the Brazilian reimbursed system  to approve new technologies, specially when it is related with personalized medicine. So, in the other words,  usually it is quite difficult to approve the personalized medicine in the SUS (“Sistema Único de Saúde”)system.

However, in the other hand, Brazil has a strong constitutional system  regarding consumer health protection. According to the Brazilian Constitution the consumer has right to have its health supported by the government (The Brazilian constitution says that the population has right to the health protection and it must be the best available in the market including the international market). The consequence is, lot of Brazilian people are suing the government to get the best treatment for its illness and this includes treatments outside of the country and the good new is they are getting this protection through the judiciary decision..

The Best Strategy to Minimize the Risk of Litigation

The Brazilian health system principles are focused  in the principles of “ prevention of harm vs promotion of benefit”.

Thus the companies must pay attention and manage the risk  control and quality of their products in order to avoid legal problems in the future such as litigation between public and private sector.

Besides, it is imperative to obey and follow the applicable Brazilian legislation. Lot of companies think that because they have Biopharmaceutical and Biomedical FDA market approval and/or EMEA market approval it is enough to launch their products in the Brazilian market hence companies usually do not pay attention in the local legislation.

Once again, Brazil has its proper legislation for Biopharmaceutical and Biomedical products and it must be obeyed. So, companies must observe it when dealing with the Brazilian market.

Brazil also has a strong consumer product system  that can be a problem for the company if not observed the Brazilian rules.

Biopharmaceutical and Biomedical investment opportunities in Brazil

The Brazilian government has made a number of arrangements to enable the infrastructure, regulation and legal apparatus necessary for companies to manufacture of the Biopharmaceutical and Biomedical product  in the local market.

Among the actions are partnerships between private laboratories, national  or international, who hold the patent of the original drug, to transfer technology to public laboratories until they gain independence to produce the drug.

In return, the Brazilian government guarantees the purchase of local production throughout the technology transfer to public laboratories. It is important to observe that the Brazilian Government  answer for the 60% of the biotechnology & pharmaceutical purchase.

The impact of expensive treatments had on the biotechnology & pharmaceuticals industry

This is a huge issue between the public and private insurers in the Brazilian market to avoid to pay expensive treatments that have on the Biopharmaceutical and Biomedical industry. Usually those issues are solved by the interference of the Judiciary. As mentioned before, the  constitution guarantees access to the best technology available in order to treat the patient and the judiciary is enforcing the law.

What efforts are being made to tackle the issue of high drug prices and increase accessibility of affordable healthcare

Typically, the cost of a Biopharmaceutical and Biomedical products do not allow do not allow price reducing by 30% of its value as it can be done for generic products, as can be done for generic products. In addition, Brazilian law does not accept generic biopharmaceuticals. As such, it is difficult to increase health care accessibility with such products.

In fact, the Brazilian government understands that local production has sufficient means to develop a price policy to lower the price of biopharmaceuticals and biomedical products, so many investments have been made to provoke more partnerships between local and international companies as well. as with public laboratories.

The Current Brazilian Health Policies to Promote Innovation in the Biopharmaceutical and Biomedical product

There are changes occurring in the Brazilian patent system in order to speed up the process of patent registration (international companies complain about the timeframe to obtain a patent protection in Brazil). With a better patent system protection the trend is to have better technology of  Biopharmaceutical & Biomedical product  available in the market. Besides, the government is making efforts in order to up date the local  regulatory system and  harmonizing its regulations with the international standers. And there are lot of investments being  done from public side, such as BNEDS to develop local manufacturer companies.

Trends to Look Forward

The Biopharmaceutical and Biomedical products are the medicine of the future. Therefore, economic investment will be necessary considering  the complexity of production and the cost  of clinical trial.

Besides, modernization of the local industrial  process is essential for the success of biological medicine in the Brazilian market. There is a need for consistency in the production process to ensure efficacy and safeness in the Brazilian local  Industry.

Professionals available in the market need to increase their knowledge since the country  still have a labor deficit in this area. It is also important that Brazil keep going the up date its  regulatory  system to international standards and make more investment in the science  sector, promoting local production and becoming more attractive to bring  foreign partner.

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