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 11 October 2023.

Clinical Research Ward, Centre for Clinical Trial

Address

:

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

Contact Information:-

Telephone

:

03-42896380

Fax

:

03-42801409

Email

:

damenthi@crc.gov.my

Contact Person

:

Dr Damenthi Nair

Status:-

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
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

:

-

Email

:

bioxis2u@gmail.com

Contact Person

:

Dr Gabriel Loh Onn Kit

Status:-

Validity

:

  1. 8 September 2021 - 7 September 2024
  2. 8 September 2024 - 7 September 2025
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.

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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