A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme

Authors

  • Joy Elizabeth van Oudtshoorn Medicines Control Council, Pretoria, South Africa.
  • Alfredo García-Arieta World Health Organisation Prequalification of Medicines Programme and Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
  • Gustavo Mendes Lima Santos Agência Nacional de Vigilância Sanitária, Brasília, Brazil.
  • Christopher Crane Therapeutic Goods Administration , Woden, Australia.
  • Clare Rodrigues Health Sciences Authority Health Products Regulation Group, Pre-Market Cluster, Singapore.
  • Craig Simon Health Canada, Ottawa, Ontario, Canada.
  • Ji Myoung Kim Ministry of Food and Drug Safety, Chungcheongbuk-do, South Korea.
  • Sang Aeh Park Ministry of Food and Drug Safety, Chungcheongbuk-do, South Korea.
  • Yusuke Okada Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Ryosuke Kuribayashi Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Chantal Pfäffli Swissmedic, Bern, Switzerland.
  • Arno Nolting Swissmedic, Bern, Switzerland.
  • Iván Omar Calderón Lojero Comisión Federal para la Protección contra Riesgos Sanitarios, Oklahoma, Ciudad de México, México.
  • Zulema Rodríguez Martínez Comisión Federal para la Protección contra Riesgos Sanitarios, Oklahoma, Ciudad de México, México.
  • Wen-Yi Hung Taiwan Food and Drug Administration, Taipei, Taiwan, R.O.C.
  • April C. Braddy United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Silver Spring, MD, USA.
  • Nancy Arciniegas Leal Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogotá. Colombia.
  • Diego Gutierrez Triana Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogotá. Colombia.
  • Mitch Clarke New Zealand Medicines and Medical Devices Safety Authority, Ministry of Health, Wellington, New Zealand.
  • Peter Bachmann CMDh at European Medicines Agency and Federal Institute for Drugs and Medical Devices, Bonn, Germany.

DOI:

https://doi.org/10.18433/J3X93K

Abstract

Purpose:  The Biopharmaceutics Classification System (BCS) based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowaivers are interpreted and regulated differently among international regulatory agencies. In this survey, the Bioequivalence Working Group (BEWG) of the International Generic Drug Regulators Programme (IGDRP) compared the criteria for BCS-based biowaivers applied by the participating regulators and organisations. Methods:  Differences and similarities regarding solubility, permeability, dissolution, excipients and fixed-dose combination products, were identified and compared in a detailed survey of each participant’s criteria for BCS-based biowaivers. These criteria were determined based upon the participants’ respective regulatory guidance documents, policies and practices. Results: This review has, with the exception of two participants who do not accept BCS-based biowaivers, revealed that most IGDRP participants interpret the BCS principles and conditions similarly but notable differences exist in the application of these principles.  Conclusion: Although many similarities exist, this review identifies several opportunities for greater convergence of regulatory requirements amongst the surveyed jurisdictions.

 

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Author Biography

Joy Elizabeth van Oudtshoorn, Medicines Control Council, Pretoria, South Africa.

 

Member of the Medicines Control Council of South Africa

Member of the Pharmaceutical and Analytical Expert Committee (P&A Committee) of the Medicines Control Council

Member of the Biogroup of the P&A Committee

 

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Published

2018-03-30

How to Cite

van Oudtshoorn, J. E., García-Arieta, A., Santos, G. M. L., Crane, C., Rodrigues, C., Simon, C., … Bachmann, P. (2018). A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme. Journal of Pharmacy & Pharmaceutical Sciences, 21, 27–37. https://doi.org/10.18433/J3X93K

Issue

Vol. 21 (2018): Pages 1-142

Section

Reports

License

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