The new criteria are hoped to stimulate research into advanced therapies in Brazil, generating income and leading to increased access for patients in Brazil.
The Brazilian Health Regulatory Agency (Anvisa) has laid out new guidelines for studies into advanced therapy products in a move to expand access in Brazil. The proposed regulations, set out in accordance with the US FDA, European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA), open the way for more research to be conducted in Brazil, stimulating the economy and attracting industry interest.
Collegiate Board Resolution (RDC) 260/2018 complements RDC 214/2018 which provides guidance on good practice in the use of human cells for research and clinical use. A third resolution is also in the final phase of discussion.
Source: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&p_p_col_id=column-2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=aprovadas-regras-para-estudos-de-terapias-celulares&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=5222996&_101_INSTANCE_FXrpx9qY7FbU_type=content (in Portuguese)