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

Joy Elizabeth van Oudtshoorn1, Alfredo García-Arieta2, Gustavo Mendes Lima Santos3, Christopher Crane4, Clare Rodrigues5, Craig Simon6, Ji Myoung Kim7, Sang Aeh Park7, Yusuke Okada8, Ryosuke Kuribayashi8, Chantal Pfäffli9, Arno Nolting9, Iván Omar Calderón Lojero10, Zulema Rodríguez Martínez10, Wen-Yi Hung11, April C. Braddy12, Nancy Arciniegas Leal13, Diego Gutierrez Triana13, Mitch Clarke14, Peter Bachmann15

1Medicines Control Council, Pretoria, South Africa.
2World Health Organisation Prequalification of Medicines Programme and Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
3Agência Nacional de Vigilância Sanitária, Brasília, Brazil.
4Therapeutic Goods Administration , Woden, Australia.
5Health Sciences Authority Health Products Regulation Group, Pre-Market Cluster, Singapore.
6Health Canada, Ottawa, Ontario, Canada.
7Ministry of Food and Drug Safety, Chungcheongbuk-do, South Korea.
8Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
9Swissmedic, Bern, Switzerland.
10Comisión Federal para la Protección contra Riesgos Sanitarios, Oklahoma, Ciudad de México, México.
11Taiwan Food and Drug Administration, Taipei, Taiwan, R.O.C.
12United 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.
13Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogotá. Colombia.
14New Zealand Medicines and Medical Devices Safety Authority, Ministry of Health, Wellington, New Zealand.
15CMDh at European Medicines Agency and Federal Institute for Drugs and Medical Devices, Bonn, Germany.


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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J Pharm Pharm Sci, 21 (0): 27-37, 2018

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DOI: http://dx.doi.org/10.18433/J3X93K