A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme

Authors

  • Alfredo Garcia Arieta Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), C/ Campezo 1. Edificio 8. Madrid, 28022, Spain http://orcid.org/0000-0002-9702-6973
  • Craig Simon Health Canada, 101 Tunney's Pasture Driveway, Ottawa ON, Canada K1A 0K9
  • Gustavo Mendes Lima Santos Agência Nacional de Vigilância Sanitária (ANVISA). SIA Trecho 5, Área Especial 54, Bloco B, Brasília, Brazil
  • Iván Omar Calderón Lojero Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Oklahoma No. 14, Colonia Nápoles, Delegación Benito Juárez, 03810, Ciudad de México, México
  • Zulema Rodríguez Martínez Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Oklahoma No. 14, Colonia Nápoles, Delegación Benito Juárez, 03810, Ciudad de México, México
  • Clare Rodrigues Health Sciences Authority (HSA), Health Products Regulation Group, Pre-Marketing Cluster, Therapeutic Products Branch. 11 Biopolis Way, Helios #11-01, Singapore 138667, Singapore
  • Sang Aeh Park Ministry of Food and Drug Safety (MFDS). Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea
  • Ji Myoung Kim Ministry of Food and Drug Safety (MFDS). Osong-eup Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea
  • Ryosuke Kuribayashi Pharmaceuticals and Medical Devices Agency (PMDA), Shin-kasumigaseki Building 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, Japan
  • Yusuke Okada Pharmaceuticals and Medical Devices Agency (PMDA), Shin-kasumigaseki Building 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, Japan
  • Arno Nolting Swissmedic, Schweizerisches Heilmittelinstitut, Hallerstrasse 7, 3000 Bern 9, Switzerland
  • Chantal Pfäffli Swissmedic, Schweizerisches Heilmittelinstitut, Hallerstrasse 7, 3000 Bern 9, Switzerland
  • Wen-Yi Hung Taiwan Food and Drug Administration (TFDA). 161-2, Kunyang St., Nangang, Taipei, 11561 Taiwan, R.O.C.
  • Christopher Crane Therapeutic Goods Administration (TGA). PO Box 100, Woden ACT 2606, Australia
  • April C Braddy U.S. Department of Health and Human Services, Food and Drug Administration (US FDA), Center for Drug Evaluation and Research, Office of Generic Drugs, 10903 New Hampshire Avenue, Silver Spring, MD 20993
  • Joy van Oudtshoorn South African Health Products Regulatory Authority (SAHPRA)Medicines Control Council (MCC). Civitas Building, 42 Thabo Sehume Street, Pretoria, South Africa
  • Diego Gutierrez Triana Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Carrera 10 No. 64-28. Bogotá. Colombia
  • Mitch Clarke New Zealand Medicines and Medical Devices Safety Authority (Medsafe), Ministry of Health, 133 Molesworth Street, Thorndon, Wellington, 6011, New Zealand

DOI:

https://doi.org/10.18433/jpps30215

Abstract

The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators of the different countries are the same product, with the consequent duplication of efforts by regulators and industry alike. The regulatory requirements on the acceptability of foreign comparator products of oral dosage forms differ between countries participating in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme. Brazil, Colombia, the European Union member States, Japan, Mexico, South Korea and the United States only accept bioequivalence studies with their local comparator. In contrast, Australia, Canada, New Zealand, Singapore, South Africa, Switzerland and Taiwan accept studies with foreign comparators under certain conditions. Canada limits its use to highly soluble drugs with a wide therapeutic range in immediate release products. Australia requires a comparison of the quantitative composition. In contrast, there are fewer restrictions on the acceptance of foreign comparators in New Zealand, Singapore, South Africa, Switzerland and Taiwan. For the WHO Prequalification of Medicines and for developing generics of the essential medicines the WHO lists comparators from different countries. In conclusion, there is currently no consensus amongst regulators on the acceptability of foreign comparator products.

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Author Biography

Alfredo Garcia Arieta, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), C/ Campezo 1. Edificio 8. Madrid, 28022, Spain

Head of Service on Pharmacokinetics and Generic Medicines

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Published

2019-01-01

How to Cite

Garcia Arieta, A., Simon, C., Lima Santos, G. M., Calderón Lojero, I. O., Rodríguez Martínez, Z., Rodrigues, C., … Clarke, M. (2019). A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme. Journal of Pharmacy & Pharmaceutical Sciences, 22(1), 28–36. https://doi.org/10.18433/jpps30215

Issue

Vol. 22 (2019): Pages 1 - 130

Section

Reports

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