Published Public Consultation – Revision of the Regulation for Expanded Access Programs, Compassionate Use, and Post-Study Medication Supply

On 26.10.2023, Anvisa (Brazil’s Health Regulatory Agency) published Public Consultation No. 1.210 (“Public Consultation”) aiming to revise the Collegiate Board Resolution – RDC No. 38/2015, which regulates expanded access programs, compassionate use, and post-study medication supply.

The purpose of the Proposal for the Revision of RDC No. 38/2013 is to update the standard to better specify (i) definitions, (ii) responsibilities of the responsible physician and sponsor, and (iii) requirements to be met in post-study care programs.

In addition to significant adjustments in existing programs (expanded access, compassionate use, and post-study supply), the standard introduces a novelty: the Patient-Indicated Access Program (PIAP), which aims to provide free access to a new or innovative medicine, registered with Anvisa or by an ICH member but not available in the country. This program is designed – patient by patient, individually – for those affected by a severe debilitating illness and/or life-threatening condition without satisfactory therapeutic alternatives available in Brazil, addressing an important gap in the existing programs.

The deadline for contributions to the Public Consultation is 60 days, and contributions must be submitted through the specific electronic form available at: https://pesquisa.anvisa.gov.br/index.php/928526?lang=pt-BR.

The Public Consultation can be accessed via the following link: https://antigo.anvisa.gov.br/consultas-publicas#/visualizar/512355