Updated: Nov 16th, 2021
For this eighth interview, Cláudia Cilento, a biochemical pharmacist from the University of São Paulo and managing partner at Inovatie, interviews Gustavo Mendes, a biochemical pharmacist graduated from USP, with specialization in Public Health from FIOCRUZ, and has worked with ANVISA since 2005.
Biochemical pharmacist, graduated from USP with a specialization in Public Health from FIOCRUZ, and mastered in Pharmacology and Toxicology at the State University of Londrina. He has been working at ANVISA since 2005 and since 2019 he has been the head of GGMED.
In these almost-two-years of the pandemic, regulatory agencies around the world have had to face the dilemma of providing quick responses to the population, but without giving up the criteria of quality, safety and efficacy of the products that have been made available to combat Covid-19.
In Brazil, according to Gustavo, it was necessary to implement some administrative and technical changes to meet these needs. “I highlight two as the ones with the greatest impact: the publication rules that allowed a risk-benefit analysis and the establishment of compliance with terms of commitment for the petitions analyzed by the Agency.”
In order to speed up the availability of drugs that could help alleviate the individual and collective effects of the pandemic, the Agency established the Committee for the Evaluation of Clinical Studies, Registration and Post-registration of drugs for the prevention or treatment of Covid-19.
Gustavo also spoke about Public Consultation 931/2020,which provided for the definition of subject codes for the administrative protocol of requests for registration of synthetic and semi-synthetic drugs classified as new and innovative.
According to him, the debate proposed by the public consultation represents a major regulatory advance for Brazil, as it will allow more agility for the country to have access to products that are already available in the international market, but which, due to administrative obstacles, take time to be made available on the Brazilian market.
“It is important to emphasize that it is not about making evidence flexible, but about bringing alternative ways to obtain registration with the Agency, thus increasing the range of possibilities for the entry of innovative products in our country. With this, we hope to modernize the concept of drug registration in Brazil.”
Gustavo also highlighted that ANVISA’s objective is to seek regulatory alignment with the main international agencies.
Abbreviated Development Path
Another point discussed in the interview was the abbreviated development path and how companies are preparing for this change. The basis of the abbreviated development is presentation of information already available in the place of conducting studies to support the proof of safety and efficacy of the new or innovative drug that is being proposed for registration.
For Gustavo, the industries will have no difficulty in acting within the new model, as the national pharmaceutical industries have invested to be aligned with the best practices. “The transition process is complex and requires effort and investment, but we know that it will be reflected in agility.”
Gustavo also said that the challenge for companies will be greater in relation to the need for investments that will be necessary for them to adjust to the Agency’s expectations for this route. “At ANVISA, we have already discussed how we are going to proceed with the analyzes and readapt the instruments we use in the evaluations to the new format.”
The specialist concluded his participation by emphasizing that ANVISA and the new companies are closer and more united, working together to maintain the relationship of trust and guarantee the quality of the information that is generated. “What we have built so far is here to stay and it tends to improve more and more.”