Brazil – Anvisa Resolution RDC 346/2020 with Alternative GMP Auditing (Good Manufacturing Practice) Requirements Due to COVID-19 Epidemic

​The Anvisa (Brazilian Health Agency) issued the Resolution RDC 346/2020 with extraordinary and temporary criteria and procedures for the certification of good manufacturing practices (GMP) for the purposes of registration and post-registration changes to active pharmaceutical ingredients, medicines and health products due to the international public health emergency of the new Coronavirus. The temporary and emergency use of information from Foreign Regulatory Authorities is allowed to replace the health inspections carried out by Anvisa for the purposes of Certification of Good Manufacturing Practices. The Foreign Regulatory Authorities accepted must be member of: I – PIC/S (Pharmaceutical Inspection Cooperation Scheme); II – MDSAP (Medical Device Single Audit Program); III – Programme to rationalize international GMP inspections of active pharmaceutical ingredientes/active substance manufacturers. Also it allows temporary and emergency use of remote inspection mechanisms, replacing the face-to-face health inspection for the purposes of Certification of Good Manufacturing Practices done by Anvisa auditors. The Resolution RDC 346/2020 is valid for 180 days after its publication date in the Official Gazette, March 13th 2020.