Implementation Plan of Phase 2 Requirement of
Bioavailability and Bioequivalence Studies
for the Registration of Generic Drugs
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In 2009, the Review Committee on the Regulation of Pharmaceutical Products in Hong Kong recommended to require bioavailability and bioequivalence (BABE) studies as registration requirement for generic drugs and to implement the requirement by phases. In April 2010, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (the Registration Committee) implemented the Phase 1 requirement for BABE studies covering 29 antiepileptic drugs.
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In August 2013, the Pharmacy and Poisons Board endorsed the decision to establish an Expert Advisory Group on BABE studies (the BABE Expert Group) to facilitate the above implementation. The BABE Expert Group was chaired by the Assistant Director (Drug) and included 11 local members from the academia, pharmaceutical trade, Hospital Authority, Department of Health, medical and pharmacy professions, and 2 overseas co-opted members. In March 2016, the BABE Expert Group endorsed an implementation plan and timeline on the Phase 2 requirement for BABE studies for consideration by the Registration Committee. In June 2016, the Registration Committee decided to implement the Phase 2 requirement for BABE studies covering 38 Critical Dose Drugs / Narrow Therapeutic Range Drugs (NTRD) at Annex according to the following requirements and timeline:
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Applications of the 38 Critical Dose Drugs / NTRD at Annex must include BABE studies in accordance with the World Health Organization (WHO) guidance document - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Other BABE studies can be accepted if official evidence of registration approval of the generic drugs in the following countries or region can be provided: Australia, Canada, the European Union, Japan or the United States.
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A.New applications for registration received before 1 August 2016
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For all the new applications for registration of the 38 Critical Dose Drugs / NTRD at Annex received before 1 August 2016 but have not been completed for registration before 1 August 2017, the applicants must satisfy the Phase 2 requirement for BABE studies before the approval of the applications.
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B.New applications for registration received on or after 1 August 2016
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With effect from 1 August 2016, all the new applications for registration of the 38 Critical Dose Drugs / NTRD at Annex must include evidence to satisfy the Phase 2 requirement for BABE studies. Otherwise, the applications will not be accepted for evaluation.
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C.Renewal applications of registered generic drugs
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With effect from 1 August 2017, all the renewal applications for registration of the 38 Critical Dose Drugs / NTRD at Annex must include evidence to satisfy the Phase 2 requirement for BABE studies. Otherwise, the registration of the generic drugs will not be renewed.
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For information related to the updated Guidance Notes on Registration of Pharmaceutical Products/Substances, please visit the following website:
- http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf
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Annex
38 Critical Dose Drugs / Narrow Therapeutic Range Drugs:
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