General Questions
Investigational Product Direct to Patients
However, there is another option in which you can apply for exemption under Regulation 15(6) Control of Drugs and Cosmetics Regulation 1984, an exemption to import unregistered products for life-threatening diseases under Pharmacy Enforcement Division.
You can also contact the following officers in the Pharmacy Enforcement Division for further information:
1. Pn Astrina Bt Abdul Salam (astrina@moh.gov.my) – Legislation Branch
2. Pn Nursyila Roziana Binti Mohd Radzi (nursyila@moh.gov.my) – Licensing Branch
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Below are the additional comments from GCP and GLP Section’s for further consideration:
NPRA recognise that the supply of IMP to trial subjects may be disrupted during COVID-19 crisis due to quarantine, travel limitation, cancellation on the site visits or other considerations if site personnel or trial subjects become infected with COVID-19 .
Considering these highly unusual circumstances, the sponsors or researcher may distribute investigational products directly to the trial subjects without involving the investigator or site personnel. Such decisions will depend on specific circumstances, including the nature of the investigational product, the ability to conduct appropriate safety monitoring and the nature of the disease under study in the trial.
Sponsor shall consider the following when implementing the home delivery option:
• Sponsor has a valid CTIL/CTX with an approved import quantity.
• Sponsor shall only distribute the investigational product on Malaysian sites to trial subjects.
• The direct-to-patient delivery of investigational product shall not raise any new safety risks.
• Sponsor shall ensure the conduct of appropriate alternative safety monitoring specifically if trial participants are not be able to come to the investigational site.
• Prior to direct distribution to the subject, sponsor should investigate the viability of the distribution via investigator or hospital pharmacy.
• If courier service is used. The sponsor need to ensure that the shortest route of transportation used during transportation and storage requirements are met. These have to be documented.
• Sponsor has to ensure that the standard operation procedure (SOP) is in place for delivery of investigational product to trial subject or their relative. In other words, the sponsor need to deliver the investigational product to the subject personally and not deliver to neighbor or placed outside the door. In addition, sponsor need to ensure the subject received adequate training for self-administration of the investigational product. All of these have to be documented.
• Sponsor is required to ensure that the subject will store the investigational product in a suitable way.
• Dispatch of the investigational product to the subject has to be done after agreement with the investigator and on the basis of the investigator prescription. Procedure for accountability must be in place.
• Sponsor may not store the personal data of the trial subject for a longer period than is required for the purpose of dispatching the medicine to the subject. Sponsor may only authorise a limited number of employees to process the personal data in order to dispatch the medicine. This has to be documented.
• Sponsor must ensure that trial subjects understand and provide consent that the trial medicine will be delivered directly to their homes.
COVID-19 Trials
Submissions to NPRA
Yes. All variation application can be submitted via e-mail.
a) Official Company chop won’t be available in such case, but company name will be reflected on the digital signature. Is this acceptable?
Yes.
b) The forms will be electronically signed, and the stamp will be typed. Is this acceptable?
Yes.
c) Would NPRA accepts e-signature for submission without the company stamp?
Yes.
Note: For variation applications that involve payment i.e., CTIL renewal, Additional IP. The following procedures apply:
- Send the variation application via email to zaril@npra.gov.my.
- The evaluator will verify the amount to pay via email. The applicant will receive the verification of amount via email.
- The applicant is required to submit the following document via courier:
- Bank draft/money order/wang pos
- Borang BPFK-001.3 – Borang penyerahan yuran pemprosesan lesen import percubaan klinikal.
- Payment amount verification email (from no. 2)
- Cover letter
Please submit the documents to:
Unit Hasil
National Pharmaceutical Regulatory Agency
Lot 36, Jalan Universiti
46200 Petaling Jaya
Selangor
Alternatively, the payment can be made using credit card/bank draft/money order/wang pos physically at the Unit Hasil’s counter every Wednesdays 8.00 am to 10.00 am
- The applicant is required to submit the official receipt via email to the evaluator (refer no. 2).