Bioequivalence and Ethics Committee Inspection
Bioequivalence (BE) studies are required for all generic medicines in the form of:
- immediate release, oral solid dosage [effective 1 January 2012]
- modified release (extended, prolonged, sustained release, etc.) [effective 12 June 2013]
- effervescent, dispersible, orodispersible, sublingual, buccal and chewable [effective 1 January 2018]
Recent Updates / Announcements
Change of Venue for the National Regulatory Conference (NRC) 2023 to M Resort & Hotel, Kuala Lumpur |
Bioequivalence & Ethics Committee Section Activities in 2022: At A Glance |
Revised Application Forms [effective 15 July 2022] |
Perlaksanaan Pemeriksaan Regulatori Dalam dan Luar Negara Secara Lapangan ('On-Site') oleh Bahagian Regulatori Farmasi Negara (NPRA) |
Application Forms and Checklist |
- BEDN - Related to inspection application for local BE
- BELN - Related to inspection application for foreign BE
- BEDE - Related to application for evaluation to determine the need for BE study inspection
- ECI - Related to registration and inspection application for ethics committee
- ECU - Any updates related to ethics committee registered with Drug Controlled Authority (DCA) such as updated list of membership or annual report
- QUERY - Any general enquiries
As example: BEDN – Inspection application for BE centre ABC.