CONTEXT: EMA and DG SANTE have signed a confidentiality agreement with ANVISA | Announcement of a new partnership between EU and Brazilian Regulatory Authorities to further develop mutual recognition and regulatory harmonisation
IMPACT: High
READ TIME: 1 min
Quality Level Mean [1 – 10]: 7
1. “This includes confidential information on the safety, quality and efficacy of both human and veterinary medicines (already authorised or under evaluation) as well as information on inspections, regulatory guidance and legislation.”
2. “The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a confidentiality arrangement with their Brazilian counterpart Agência Nacional de Vigilância Sanitária (ANVISA).”
3. “The arrangement allows its participants to exchange sensitive information about medical and medicinal products.”
4. “Confidentiality arrangements of this type contribute to timely information exchanges on fast emerging issues with global impact such as shortages of medicines, quality concerns or safety questions and are the corner stone on global cooperation, for example in crises such as the current COVID-19 pandemic.”
5. “It provides the framework under which EU and Brazilian authorities will develop their regulatory cooperation.”
Source URL: https://www.ema.europa.eu/en/news/confidentiality-arrangement-between-eu-brazilian-regulatory-authorities