Local Bioequivalence (BE) Studies Centres
As of 1 January 2020, NPRA had revised the way the clinical and bioanalytical facilities under the NPRA BE Centre Compliance Programme. Clinical and bioanalytical facilities are listed separately and may collaborate freely with any other listed facilities. Collaborating facilities must ensure that different phases (clinical & bioanalytical) of the BE study are conducted within the listing period.
Failure to do so may result in the BE study report to be rejected during product registration submission.
Failure to do so may result in the BE study report to be rejected during product registration submission.
Clinical Facilities
There are 3 clinical facilities that are listed in NPRA BE Centre Compliance Programme as of 11 October 2023.
Clinical Research Ward, Centre for Clinical Trial
|
Address |
: |
Clinical Research Ward (CRW) |
|
Contact Information:- |
||
|
Telephone |
: |
03-42896380 |
|
Fax |
: |
03-42801409 |
|
|
: |
|
|
Contact Person |
: |
Dr Damenthi Nair |
|
Status:- |
||
|
Validity |
: |
|
Info Kinetics Sdn Bhd.
Questra Clinical Research Sdn. Bhd.
Bioanalytical Facilities
There are 4 bioanalytical facilities that are listed in NPRA BE Centre Compliance Programme as of 16 February 2022.
Bioxis Sdn. Bhd.
|
Address |
: |
Bioxis Sdn. Bhd. PMT 1241, Jalan Perindustrian Bukit Minyak 8, Taman Perindustrian Bukit Minyak 14100 Simpang Ampat Pulau Pinang |
|
Contact Information:- |
||
|
Telephone |
: |
+604-5057358 |
|
Fax |
: |
- |
|
|
: |
bioxis2u@gmail.com |
|
Contact Person |
: |
Dr Gabriel Loh Onn Kit |
|
Status:- |
||
|
Validity |
: |
|
Info Kinetics Sdn Bhd.
Attest Research Sdn Bhd (Penang) (formerly known as Pusat Kajian Bioekuivalens (BE), Pharmacy-Attest Research Sdn Bhd (ARSB) BA/BE Centre, Pusat Pengajian Sains Farmasi, USM)
Questra Clinical Research Sdn. Bhd.