Brazil’s Anvisa published in October 2022 a new regulatory framework for new and innovative medicines that will simplify and relax the information to be submitted in the registration process. These regulations seek to promote the population’s access to innovations in health, without implying an increase in risks.


The new regulatory framework for drug registration brings a new regulatory approach, with the creation of abbreviated and complete registration paths. This improvement of the regulatory process stimulates innovation in drug development by allowing the substitution of eventual new studies by existing data, in order to reduce the need for studies, when the data are already available or can be obtained through alternative mechanisms to the classic clinical studies.

The objective of the new regulatory framework approved by Anvisa is to favor the registration of new and innovative drugs; This innovation in health must have its main objective the promotion of health and quality of life of the population.


Collegiate Directive Resolution (RDC) 753 September 2022:

  • Provides on the Criteria for granting the registration of new, innovative, generic and similar drugs.

Normative Instruction (IN) 184, of September 28, 2022:

  • Provides on the Administrative Proceedings for applications for the registration of new and innovative medicines.


Purpose of the Proposal

The proposals, aligned with the international scenario, also foresee the contribution of technical data in the decision making process, such as:

  • Protocols
  • Guides
  • Monographs
  • Authorizations
  • Votes
  • Letters
  • Certificates
  • Statements
  • Reports
  • Technical opinions issued by national or international entities containing information regarding the safety and efficacy of the drug or API, including real world evidence and data (Real World Evidence – RWE / Real World Data – RWD).


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About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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