Malaysia

DCT Feasibility Assessment Malaysia The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current and proposed regulatory landscape applicable in Malaysia in relation to Decentralized Clinical Trials (“DCT”). Malaysia abides by the regulations set forth by the National Pharmaceutical Regulatory...

2.1 Name of Regulatory Authority National Pharmaceutical Regulatory Agency (NPRA) , an agency under the Malaysian Ministry of Health (MOH). The Drug Control Authority specifically looks after the regulation of drugs (including biologics). The...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   The documents required may vary for each Committee. The standard EC submission package ...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  As outlined in the Malaysian Guideline for Application of CTIL and CTX , the general req...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   Yes . For any Interventional Clinical Research that involves drugs, the principal investigator has to register with the National M...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. "All biological specimens regardless of purpose (diagnostic, research, etc.) must secure a Quarantine Clearance before transportation . This in...

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . There is no regulation preventing the conduct of DCTs. DCTs are allowable, subject to ...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Personal Data Protection Act  The Personal Data Protection Act covers the processing of personal data, whether...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? Yes . Potential trial subjects may be recruited: by advertisements in a ne...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan Pediatric Investigation Plans are not required in Malaysia. 10.3 Clinical Study (Interventional or Observational) Clinical Tria...

National Pharmaceutical Regulatory Agency (NPRA) Ministry of Health Malaysia (n.d.) Official Portal ,  NPRA. National Pharmaceutical Control Bureau (10 December 2009) Edaran Seperti di Lampiran ,  Ministry of Health Malaysia. C...

Link to control of drugs and cosmetic regulations – Inclusive of Forms 1-5 Informed Consent Form Template