A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme


  • Andrew Tam Health Canada
  • Alfredo Garcia-Arieta AEMPS, Spain; WHO-Observer
  • Ivana Abalos ANMAT, Argentina
  • Eduardo Agostinho Freitas Fernandes ANVISA, Brazil
  • Gustavo Mendes Lima Santos ANVISA, Brazil
  • Zulema Rodriguez Martinez COFEPRIS, Mexico
  • Milly Divinsky CPED, Israel
  • Rami Kariv CPED, Israel
  • Henrike Potthast EC, Europe; BfArM, Germany
  • April C. Braddy FDA, United States
  • Clare Rodrigues HSA, Singapore
  • Erwin Guzman Aurela INVIMA, Colombia
  • Liliana Carolina Arevalo Gonzalez INVIMA, Colombia
  • Diego Gutierres Triana INVIMA, Colombia
  • Ben Jones Medsafe, New Zealand
  • Choongyul Ahn MFDS, Republic of Korea
  • Hyuna Kim MFDS, Republic of Korea
  • So Hee Kim MFDS, Republic of Korea
  • Ryosuke Kuribayashi MHLW/PMDA, Japan
  • Aya Myoenzono MHLW/PMDA, Japan
  • Kohei Shimojo MHLW/PMDA, Japan
  • Joy van Oudtshoorn SAHPRA, South Africa
  • Cornelia Bigler Swissmedic, Switzerland
  • Ricarda Meincke Swissmedic, Switzerland
  • Matthias S. Roost Swissmedic, Switzerland
  • Chantal Walther Swissmedic, Switzerland
  • Li-feng Hsu TFDA, Chinese Taipei
  • Christopher Crane TGA, Australia
  • Tony Jarman TGA, Australia




The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP) indicated that the criteria for selecting an alternative comparator product varies. For most members of the BEWGG, an existing marketed generic that was approved based on a comparison with the locally registered innovator product can be used, contingent on criteria that ranges from allowing any generic to be used, to allowing only specific criteria-defined generics to be used. Notwithstanding the acceptability of a generic as an alternative comparator, it is not always the preferred comparator for several jurisdictions. Some jurisdictions require the use of a locally sourced alternative innovator comparator (e.g., the same medicinal ingredient manufactured by a different company) or a foreign innovator comparator. Unlike the other members of the BEWGG, the European Union (EU) has no such options available, rather mechanisms are in place to allow manufacturers to develop a new comparator. The criteria described herein regarding the use of an alternative comparator product can also be applied to scenarios where a specific strength of a series of strengths or an innovative fixed dose combination are discontinued. The results of the survey demonstrate that while criteria for selecting alternative comparator products are not harmonized among the BEWGG participants, the common concern for all jurisdictions is to select a comparator product that meets the safety and efficacy standards of the original innovator product.


Download data is not yet available.




How to Cite

Tam, A., Garcia-Arieta, A., Abalos, I., Agostinho Freitas Fernandes, E., Mendes Lima Santos, G., Rodriguez Martinez, Z., … Jarman, T. (2022). A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme. Journal of Pharmacy & Pharmaceutical Sciences, 25, 323–339. https://doi.org/10.18433/jpps33081



Review Articles