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.

Clinical Facilities

The following clinical facilities are updated as of 7 September 2020.

Borneo Kinetics Sdn. Bhd.

Address

:

Borneo Kinetics Sdn. Bhd.,

CRC Research Ward, Level 6,

Ward Block, Sarawak Heart Centre 
(Pusat Jantung Sarawak),

94300 Kota Samarahan, Sarawak. 

Contact Information:-

Telephone

:

+6082 668 111

Fax

:

+6082 668 025

Email

:

wntiong.bksb@gmail.com
borneokinetics@gmail.com

Contact Person

:

Tiong Wen Ni

Status:-

Validity

:

     I.        18 September 2013 - 18 September 2016

   II.        18 September 2016 - 17 September 2019

 III.        18 September 2019 - 17 September 2022
Clinical Research Ward, Clinical Trial Unit, Clinical Research Centre
Info Kinetics Sdn Bhd.
Clinical Research Centre Hospital Seberang Jaya
Clinical Research Centre Perak (CRC Perak)
Questra Clinical Research Sdn. Bhd.

Bioanalytical Facilities

The following bioanalytical facilities are updated as of 28th July 2020.

Bioxis Sdn Bhd

Address

:

Bioxis Sdn Bhd,

Suite 0007, 0010 & 0012,

Koridor Utara Biotech Centre,

No. 1114, Jalan Perindustrian Bukit Minyak 18, Taman Perindustrian Bukit Minyak, 14100 Simpang Ampat, Pulau Pinang. 

Contact Information:-

Telephone

:

04-6468388

Fax

:

04-6468388

Email

:

bioxis2u@gmail.com

Contact Person

:

Dr Gabriel Loh Onn Kit

Status:-

Validity

:

19 January 2017 – 18 January 2020
Info Kinetics Sdn Bhd.
Pusat Kajian Bioekuivalens (BE), Pharmacy-Attest Research Sdn Bhd (ARSB) BA/BE Centre, Pusat Pengajian Sains Farmasi, Universiti Sains Malaysia (USM)
Questra Clinical Research Sdn. Bhd.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Tuesday 27 October 2020, 11:22:44.
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