Malaysia: Vaccines

Clinical Trial Data Requirements

Malaysian Guideline for Good Clinical Practice.

Before a clinical trial begins the followng documents should be on file:
-Investigator's Brochure
-Signed protocol and amendments
-Information given to trial subjects
-Financial aspects
-Insurance statement (where required)
-SIgned agreement between parties
-IRB/EC approval document
-IRB/EC composition
-RA authorisation of protocol
-CV of investigators
-Normal lab values for tests in protocol
-Procedures/tests/labs to be done
-Sample of investigation product labels
-Handling instructions for investigational products
-Investigational product shipping records
-Investigational product analysis certificate
-Blinding decoding procedures
-Master randomization list
-Pre-trial monitoring report
-Trial initiating monitoring report

Clinical Trials Import Authorization

Guidelines for Application of Clinical Trial Import License and Clinical Trial Exemption in Malaysia. Required documents are listed in section 4.4 of the guidelines.

Clinical Trial Timelines

According to a presentation given by an employee of the NPCB, approval time takes:
EC/MoH: 6-8 weeks
Universities: 4-8 weeks
National Heart Institute: 3-6 weeks
DCA: 4-8 weeks
(parallel submission to DCA and EC is allowed)

The presentation is available here.

Clinical Trial Costs

MYR 2000

In-Country Manufacturing Requirements

Malaysia complies with international GMP.

Insurance Requirements

Trial sponsors are required to have insurance and are responsible for covering the costs of treatment for trial subjects in the event of trial-related injuries.

Liability Policy

Malaysia follows the Association of the British Pharmaceutical Industry Guidelines for Compensation in Clinical Trials. 

The sponsor’s standard indemnity template is generally accepted.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

2 cinical trials have been approved from July 2012 to July 2014.

Product Registration Data Requirements

Appendix 3 of Drug Registration Guidance Document contains the Guidelines on Registration of Biologics, which should be in the ASEAN CTD format and adhere to the general product registration requirements in Malaysia.

General Requirements
-Part 1: Administrative data and product information
-Part 2: Data to support product quality (Quality Document)
-Part 3:Data to support product safety (Nonclinical Document)
-Part 4: Data to support product safety and efficacy (Clinical Document)cs.

Product Registration Timelines

According to the Drug Registration Guidance Document:
New Drug Products: 245 working days
Biologics: 245 working days

Product Registration Costs

New Drug Product: RM 4000
Biologics: RM 5000
Appendix 1 of the Drug Registration Guidance Document has a full list of fees.

Post Registration Labeling Requirements

Labelling requirements are found in Appendix 9 of the Drug Registration Guidance Document.

Post Registration Pharmacovigilance Requirements

Product registration holders are required to immediately inform the Director of Pharmaceutical Services of any adverse reactions that come from the use of their product. 

The Drug Registration Guidance Document Section 17 covers post-marketing activities. 

 

Last Updated

October 20, 2015.