Regulatory Collaboration - IGDRP generic drug product regulatory gap analysis

  • by IGDRP - 29 November 2016 - 4:20pm
News

The Brazilian Health Regulatory Agency (ANVISA) led a regulatory gap analysis survey under the auspices of IGDRP to identify regulatory similarities amongst the IGDRP members, and gaps that may create challenges for work-sharing and collaboration. The survey of the World Health Organization’s (WHO) Prequalification Team, the European Union, and 11 Regulatory Authorities covered the definition of a generic drug product and various regulatory and registration requirements for generic drugs, such as: 

  • the selection of international reference products for use in bioequivalence studies;
  • criteria for granting biowaivers;
  • issues relating to the assessment of Quality information (e.g., stability data requirements for generic drug product applications); and
  • requirements on the use of national or regional pharmacopoeias.

The data collected was reported in the article entitled Regulatory Collaboration - IGDRP generic drug product regulatory gap analysis published in the WHO Drug Information, volume 30, nº 3, 2016.