Bioequivalence 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]

The BE studies shall be conducted at BE centres accredited by NPRA in order to support the registration of generic medicine in Malaysia. In line with this requirement, NPRA began BE centre inspection since January 2012.

The Drug Control Authority (DCA)’s mission is to ensure all parties involved in clinical trials in Malaysia comply with the principles embossed in the Malaysian Guideline for Good Clinical Practice (GCP) which is based on the ICH Guideline for Good Clinical Practice E6 (R2) document. Ethics committee (EC) play a crucial role in assessing the scientific and ethical aspects of a clinical trial to safeguard the rights, safety and well-being of clinical trial subjects. All EC approving drug related clinical trial requiring Clinical Trial Import Licence (CTIL) or Clinical Trial Exemption (CTX) must be registered with the DCA. In recent years, NPRA has expanded its activities in EC inspections.

This page contains all information with regard to BE and EC inspection and Desktop Evaluation on the Need for BE Study Inspection (BEDE). If the information you seek is not available, kindly contact us at beec@npra.gov.my. We strongly suggest for you to use the following prefixes in the ”SUBJECT” for all correspondence through email:

• 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.