- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > bioavailability
- Palabras clave > bioequivalence
- Palabras clave > bioequivalence - biowaiver
- Palabras clave > bioequivalent generic products
- Palabras clave > Biopharmaceutics Classification System (BCS)
- Palabras clave > biowaiver testing procedure
- Palabras clave > FDC finished pharmaceutical product (FDC-FPP)
- Palabras clave > interchangeability - registration requirements
- Palabras clave > Multisource (Generic) Pharmaceutical Product
- Palabras clave > registration - biosimilars
(2015; 36 pages)
EFMHACA would like to acknowledge the United States Agency for International Development (USAID) and the U. S. Pharmacopeial Convention Promoting the Quality of Medicines Program (USP PQM) for the financial and technical support delivered in preparation of this Guidance on Waiver of In vivo Bioequivalence Requirements.
This document is intended to provide guidance on biowaiver implementation under The Ethiopian Food, Medicine and Health Care Administration and Control Authority (EFMHACA). The requirements set in this guidance document are applicable to new applications for registration of a pharmaceutical product based BCS classifications, dose proportionate formulation (usually for lower strengths) and variation to registered products which have systemic action of oral solid dosage form. Suspensions should be treated in the same way as for immediate release solid oral dosage form. Multisource products as described in section 1 of Annex IV: requirement for bioequivalence study of Guideline for Registration of Medicines (EFMHACA), 2014 their availability are self- evidence and not require bioequivalence study are not covered in guidance document. Locally acting medicines such as locally acting antacids and anti-helminthic do not require bioequivalence study are not covered in this guidance document.