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  Malaysian Guideline for Bioequivalence Inspection

[ Download the Malaysian Guideline for Bioequivalence Inspection here - PDF, 728KB ]

Effective from 1st January 2012, bioequivalence (BE) studies are required for all generic medicines which are in the form of immediate release, oral solid dosage and the BE studies shall be conducted at BE centre accredited by NPCB in order to support the registration of generic medicine in Malaysia. In line with this requirement, NPCB has started to conduct BE centre inspection since January 2012. BE Centre inspections were initially conducted based on procedure outlined in Guidelines for Good Clinical Practice (GCP) Inspection, Malaysia issued in October 2010. Since then, there has been a substantial change in many areas of BE Centre inspection especially on the administrative procedure. Therefore, it is very timely and necessary to issue a new guideline addressing the current practise for BE Centre inspection.

This new guideline outlined the whole process of NPCB Compliance Programme for BE Centre. The guideline provide a wide range of information starting from an introduction covering the background of the programme; followed by a main section addressing application procedure, inspection fee, conduct of inspection, category of inspection approval of BE Centre and acceptance of BE studies; finally a section on appeal procedure. Besides that, it also explains the area and documents that will be reviewed and inspected by NPCB inspectors in the appendices of this guideline.

I hope that this new guideline will be employed as a useful guide for both local and foreign BE Centre as well as other parties during their applications for BE Centre inspection by NPCB.

Tan Ann Ling
Director of Pharmacy Regulatory
National Pharmaceutical Control Bureau
Ministry of Health Malaysia

October 2014

Download the Malaysian Guideline for Bioequivalence Inspection here - PDF, 728KB ]

 

 

 



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