HSA Singapore Issues Updated Version of Regulatory Requirements For Clinical Trial New Applications And Subsequent Submissions

The new version Rev. No. 004 , issued on 28 April 2021, clarified on regulatory requirements for clinical trials of controlled drugs or psychotropic substances.  

Additional import and export controls under the Health Products (Therapeutic Products) Regulations 2016 and the Misuse of Drugs Regulations are applicable to clinical trials using clinical research materials containing psychotropic substances and/or controlled drugs. 

The sponsor and investigators must comply with the duties and obligations relating to the handling and storage of controlled drugs and psychotropic substances stipulated in the Misuse of Drugs Regulations, including prescription use, record keeping and destruction. 

If the clinical research material containing controlled drugs or psychotropic substances are to be exported out of Singapore, a corresponding export licence shall be applied and issued before the export is made. 

Additional requirements for controlled drugs 

: In addition to submitting the clinical trial application to HSA for review and approval, approval from the Central Narcotics Bureau (CNB) will also be required for the clinical trial. HSA will coordinate with the applicant on the submission to CNB after the clinical trial application is considered approvable by HSA. The clinical trial may only be initiated after written approvals have been obtained from both HSA and CNB. 

In addition to dealers’ licences or Clinical Research Material (CRM) Notification (where applicable), additional import and wholesale licences for the controlled drug are required from the HSA Licensing and Certification Branch (LCB). Following receipt of the authorisation (CTA) / acceptance of notification (CTN) / approval (CTC) for the clinical trial and acknowledgement of CRM notification by HSA, copies of the CTA / CTN / CTC and the CRM-notification should be submitted to the HSA LCB as supporting documents for the application of import and wholesale licences for controlled drug. HSA LCB will then process the application and issue the Import Licence and Wholesale Licence for the controlled drug. 

The Controlled Drug Wholesale Licence can only be issued to a registered pharmacist within the company. The applicant for the import licence for Controlled Drugs should also be the Controlled Drug Wholesale Licence holder to whom the import licence may be issued. The company making the application for Controlled Drug Wholesale Licence would be subject to an audit by the HSA Licensing and Certification Branch and the licence would be issued 10 days after close-out of the audit. The consignment of imported drugs can only be used for its designated purpose and must not be distributed or sold outside of the trial. 

For more details, refer toCLINICAL TRIALS GUIDANCE – REGULATORY REQUIREMENTS FOR NEW APPLICATIONS AND SUBSEQUENT SUBMISSIONS (GN-IOCTB-04 Rev. No. 004, 28 April 2021) https://www.hsa.gov.sg/docs/default-source/hprg-io-ctb/hsa_gn-ioctb-04_new_and_subsequent_appl_28apr2021.pdf/ 

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