Brazil creates Emergency Technical Committee for monkeypox

BRASILIA. KAZINFORM - Brazil’s national drug regulator Anvisa has created the Monkeypox Emergency Technical Committee so that technical areas of clinical research, registration, good manufacturing practices, pharmacovigilance, and advanced therapies work in a collaborative process, including with health professionals and the scientific community, Agencia Brasil reports.

The committee is expected to bring together the best experiences available among regulatory authorities, allowing to accelerate the development and actions involving clinical research, and the authorization of medicines and vaccines.

According to Anvisa, the technical team shall provide guidance on clinical trial protocols, and discuss with developers guidance regarding clinical trials of drugs intended to treat, prevent or diagnose the disease causing the public health emergency. The purpose of these guidelines for developers, including academic experts, is to enable the rapid approval and the carrying out of well-designed tests that provide consistent data needed for decision-making, and avoid duplication of investigations.

Photo: agenciabrasil.ebc.com.br