BR Brasilien
  • 11 - Medizintechnik

Pharmaceutics (ICS code(s): 11.120)

Draft resolution number 1135, 23 December 2022; (6 page(s), in Portuguese)

This Draft Resolution is regarded to a regulatory proposal for the establishment of specific criteria and procedures for defining the Equivalent Foreign Regulatory Authorities of the sanitary inspection process of manufacturers of active pharmaceutical ingredients, Cannabis products for medicinal purposes, medicines and biological products. And the optimized Good Manufacturing Practices (GMP) Certification review process. The Regulatory Trust Building Program for the recognition of the equivalence of the health inspection processes of an AREE is applicable exclusively to regulatory authorities or member entities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).