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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

There are 3 clinical facilities that are listed in NPRA BE Centre Compliance Programme as of 29 September 2025.

Clinical Research Ward, Centre for Clinical Trial, Hospital Ampang

Address:

Clinical Research Ward (CRW),
Centre for Clinical Trial,
Level 7, Hospital Ampang,
Jalan Mewah Utara, Pandan Mewah,
68000 Ampang, Selangor.

Validity:

  1. 9 September 2014 – 9 September 2017
  2. 9 September 2017 – 8 September 2020
  3. 9 September 2020 – 8 September 2021
  4. 9 September 2021 – 8 September 2022
  5. 9 September 2022 – 8 September 2025
  6. 9 September 2025 – 8 September 2030

Contact Information:-

Telephone

+603-42896558

Fax

N/A

Email

damenthi@moh.gov.my

Contact Person

Dr. Damenthi Nair
 
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 29 September 2025.

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]

Address:

Attest Research Sdn. Bhd.
Lot 16030, Plot 88G, Lintang Bayan Lepas 10,
Kawasan Perindustrian Bayan Lepas,
11900 Bayan Lepas,
Pulau Pinang.

Validity:

  1. 23 October 2018 – 22 October 2021
  2. 23 October 2021 – 22 October 2022
  3. 23 October 2022 – 23 October 2025

Contact Information:-

Telephone

+604- 611 5099

Fax

+604-659 6517

Email

nandadeep@attestresearch.com

Contact Person

Dr. Nandadeep Pralhad Sardar
 
Bioxis Sdn. Bhd.
Info Kinetics Sdn. Bhd.
Questra Clinical Research Sdn. Bhd.

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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  • Last Modified: Khamis 04 Disember 2025, 16:14:20.

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