Proceedings: DIA Annual Canadian Meeting 2019

Anvisa Working Toward New Regulatory Framework for Innovative Synthetic and Semi-Synthetic Drugs in Brazil

Ana Carla da Silva Carvalho
Nathalia Cangussu Ferraz
Brazilian Health Regulatory Agency (Anvisa)

he Brazilian Health Regulatory Agency (Anvisa) is a relatively young regulatory agency but with a large scope which encompasses drugs, pesticides, foods, cosmetics, health products, sanitizers, blood, tissues, cells and organs, and tobacco, and a large population (currently estimated at more than 210 million people) to serve.

Since first created in 1999, the regulation defining requirements for registration and marketing of medicines in Brazil has undergone important changes. The Coordination of Innovations, part of the General Office of Drugs, is currently working on an innovative proposal to change Resolução da Diretoria Colegiada (RDC) nº 200/2017 which sets out criteria for granting and renewing registration of drugs with synthetic and semi-synthetic active ingredients in Brazil.

The major goal of the current review is to enable availability of effective and safe innovative medicines to Brazil’s population even when existing evidence has not been generated by the traditional clinical development model of consecutive phase 1, phase 2, and phase 3 clinical trials. Moreover, the proposal also aims to reduce unnecessary studies to (1) protect patients and volunteers as well as (2) to reduce development and other investment costs, which may reduce the product’s final price and thereby also increase access.

Greater flexibility in Brazilian regulation, in the context of various new types of scientific evidence available today, aligns with what other prominent international regulatory agencies are already practicing. In reviewing this type of evidence, it is essential to keep in mind a balance in the regulators’ role so that these more flexible regulatory requirements remain adequate to fulfill the regulatory responsibilities of promoting and protecting the public health.

At the DIA Annual Canadian Meeting 2019 topics such as the time required to respond to a regulatory request; active interaction with a regulatory agent during the process of drafting new documents required to meet new technical requirements; and requesting longer times to submit these and other appropriate documents were discussed. These topics resonated with our own experience in Brazil.

Patient participation in the regulatory processes has aroused much interest among regulators, industry, and patients. These discussions emphasized that patients can contribute their unique vision to facilitate better understanding of the therapeutic context, to the process of identifying and selecting outcomes considered clinically significant for each condition, and to deciding which treatments should be the focus of further research. All these components illustrate the crucial importance of active patient participation to enrich regulatory processes and drug development.

These discussions further reinforced the need to encourage participation by all those who will be directly or indirectly affected by the regulatory agency’s work in reviewing this regulation.

Anvisa Public Consultation

Anvisa is considering these and other fundamental issues in introducing a more flexible approach to bringing innovative medicines to Brazilians. In this sense, we see that the current regulatory scenario increasingly drives us to seek and value participation from industry and society. For Anvisa, such participation currently takes place through public consultations. Anvisa’s Public Consultation entails publishing drafts of regulatory actions for comments and suggestions from the general public for a specified period. These comments and suggestions are not counted as votes, but as information for the Agency to consider while consolidating the final text to be submitted to the Agency’s Collegiate Board for subsequent decision.

The construction of the new RDC for registration of innovative synthetic and semi-synthetic drugs by Anvisa is being carried out with the direct active participation of industry sponsors and associations through a scheduled series of working group meetings. This model has proven very productive as it allows alignment between the regulator and the regulated sector to mutually create rules that are cooperative with industry (especially Brazilian national companies) and can bring to the Brazilian population safe and effective therapeutic options which may otherwise have had registration applications limited by legal requirements.

Another very relevant point was the provision of regulatory guidances on certain specific topics. While lacking the force of law, such documents are extremely useful by providing companies with more details on how to gather and present evidence to meet the legal requirements set by the regulator. Anvisa is working on several new guidance documents in parallel with the revision of the RDC so that they can be published simultaneously.

Real world evidence and other crucial scenarios analyzed in Anvisa’s regulatory review were mirrored by discussions of these same topics at the DIA Annual Canadian Meeting 2019, which Anvisa was pleased to attend. These valuable insights will further fuel regulatory discussions by the agency in its mission to bring more innovation and protection to the health of the Brazilian population.