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?