Clinical Trial Data Requirements
Before a clinical trial begins the followng documents should be on file:
-Signed protocol and amendments
-Information given to trial subjects
-Insurance statement (where required)
-SIgned agreement between parties
-IRB/EC approval document
-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
In-Country Manufacturing Requirements
Malaysia complies with international GMP.
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.
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.
-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.
October 20, 2015.