Cohortias the CRO of LATAM
Clinical trial regulation in Brazil
New clinical trial regulation in Brazil 2023 – Top CRO of Latin America
Clinical trial regulation in Brazil is set to undergo significant changes in 2023, with the implementation of new rules that aim to improve the quality of clinical trials conducted in the country.
These changes come as part of a wider effort by the Brazilian government to modernize its healthcare system and strengthen its position as a leader in the field of clinical research.
The new regulations, which were announced in 2019, will come into effect on April 23, 2023.
They will replace the existing regulations, which have been in place since 2013.
The new rules are intended to streamline the regulatory process for clinical trials in Brazil, while also improving the quality of data generated by these trials.
One of the key changes introduced by the new regulations is the requirement for sponsors to provide more detailed information about their clinical trials.
Sponsors will need to provide a detailed protocol for their trials, including information on the study design, endpoints, and statistical methods.
They will also need to provide a detailed risk management plan, which outlines how they will identify, evaluate, and mitigate risks associated with their trials.
In addition, the new regulations will require sponsors to provide more information on the informed consent process for clinical trial participants.
This will include information on the nature of the trial, the risks and benefits of participation, and the participant’s right to withdraw from the trial at any time.
Another important change introduced by the new regulations is the requirement for sponsors to conduct clinical trials in compliance with international standards for good clinical practice (GCP).
This includes the use of standardized study procedures, the training of study staff, and the implementation of quality control measures to ensure that data generated by the trial is accurate and reliable.
The regulation in Brazil also introduce stricter rules around the conduct of clinical trials involving vulnerable populations, such as children and pregnant women.
Clinical trial regulation in Brazil
Sponsors will be required to obtain explicit consent from the parents or legal guardians of children participating in clinical trials, and from pregnant women, who will need to be informed of the risks and benefits of participation in the trial.
The implementation of the new regulations is expected to have a significant impact on the clinical trial landscape in Brazil.
The Brazilian government has been working to attract more clinical trials to the country in recent years, in a bid to improve access to new treatments for Brazilian patients and to boost the country’s position as a leader in clinical research.
The new regulations are expected to make Brazil a more attractive destination for clinical trials, by providing greater clarity and certainty around the regulatory process.
The requirement for sponsors to comply with international standards for GCP is likely to reassure international sponsors that their trials will be conducted to the highest standards of quality and safety.
At the same time, the new regulations are likely to lead to greater scrutiny of clinical trials conducted in Brazil, which could pose challenges for some sponsors.
Sponsors will need to ensure that their trials are conducted in compliance with the new rules, and that they are able to provide the detailed information and documentation required by the authorities.
Despite these challenges, the implementation of the new regulations is widely seen as a positive development for clinical research in Brazil.
The new rules are expected to improve the quality of clinical trials conducted in the country, which will benefit both patients and the wider healthcare system.
They will also help to strengthen Brazil’s position as a leader in the field of clinical research, and to attract more international sponsors to the country.
In conclusion, the new regulations governing clinical trials in Brazil represent an important step forward for the country’s healthcare system.
They are expected to improve the quality and safety of clinical trials conducted in the country, while also providing greater clarity and certainty for sponsors.
The implementation of these new rules is likely to have a significant impact on the clinical trial landscape in Brazil, and is a positive development for patients, sponsors, and the wider healthcare community.
