FAQ on Clinical Trials in Malaysia 

(Updated 15 June 2023)

A) General

1. Referring to the circular titled ‘Updates on the Requirements of GMP Evidence for Overseas Manufacturers for the Purpose of Clinical Trial Import License (CTIL) Application’ dated 11 May 2023, what are the acceptable GMP evidence that can be provided by ICH Regulatory Member Countries?

Valid GMP evidence that contains the following information should be submitted:

  1. Name of Investigational Product (IP) manufacturer
  2. Address of manufacturing site under inspection
  3. Scope of Inspection
  4. Dosage form covered during inspection
  5. Inspection date
  6. Conclusion of the inspection
  7. Validity of GMP Status
  8. Official Stamp of the Issuing Authority
2. Which category of Investigational Product (IP) is currently accepted by NPRA for First-in-Human (FIH) studies in Malaysia?
3. Which trial site can conduct First-in-Human (FIH) studies in Malaysia?

The trial site listed under the NPRA Phase I Unit Inspection & Accreditation Programme can conduct FIH studies in Malaysia. Please refer to the link below for more information on the NPRA Phase I Unit Inspection & Accreditation Programme: 

https://www.npra.gov.my/index.php/en/component/sppagebuilder/910-list-of-accredited-phase-i-units.html



4. How to apply for compassionate use programme?
5. In case of absence of drug destruction certificate, what would be the documentations that NPRA would accept in place of the above document?

It is specified in our guideline that "For local disposal, all investigational products should be disposed by the authorised bodies/ authority and documented." Hence, the drug destruction documentation should be provided.  

6. How is submission for Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) performed?

It is specified in our guideline that applicant is advised to contact officers from Investigational Product Evaluation and Safety Section (IPESS), Centre of Product and Cosmetic Evaluation (CPCE) to schedule for an appointment to submit the CTIL application in person. 

However, applicants also can submit CTIL and/or CTX applications by following this procedure:

1. In order to submit your CTIL and/or CTX application, email Dr. Zaril Harza Zakaria at zaril@npra.gov.my

2. The appointed screening officer will contact the applicant to obtain the cloud storage link of complete screening document.

3. Once the screening is deemed satisfactory, applicant will be notified via email on the screening status and payment amount will be verified by using Lampiran A Borang Penyerahan Yuran Pemprosesan.

4. Payment process [for CTIL application only]:

    i. Document required for payment process:

       • Credit card/ bank draft/ money order /wang pos

       • Lampiran A: Borang Penyerahan Yuran Pemprosesan

       • Cover letter

    ii. Payment method:

    A. Payment at Unit Hasil, NPRA

       • Payment can be made using credit card/ bank draft/ money order/ wang pos physically at the Unit Hasil’s counter Monday to Friday (except on Public Holiday) from 8.00 am to 5.00 pm. 

    B. Payment by post

       • Bank draft/ money order/ wang pos shall be posted to the following address:

       Unit Hasil,

       Bahagian Regulatori Farmasi Negara

       Lot 36, Jalan Universiti

       46200 Petaling Jaya

       Selangor

[Note: Please ensure you get a copy of the receipt for proof of payment]

5. Once payment has been made, submit a copy of the official receipt together with the full dossier to the following address.

       U/P: Name of Screening Officer

       Seksyen Penilaian dan Keselamatan Produk Kajian,

       Bahagian Regulatori Farmasi Negara

       Lot 36, Jalan Universiti

       46200 Petaling Jaya

       Selangor

6. Upon acceptance, Lampiran C1: Pengesahan Penerimaan Permohonan Lesen Import Percubaan Klinikal for CTIL applications/ Lampiran B: Pengesahan Penerimaan Permohonan Kebenaran Mengilang Produk Tidak Berdaftar untuk Tujuan Percubaan Klinikal will be provided to applicant.

7. For CTX application, the submission can be done via courier.




B) Managing Trials during Covid-19 in Malaysia

1. For COVID trials, it is imperative that we move as fast as possible to complete submissions to NPRA for their review, so that study start-up can be as quick as possible (due to the nature of this pandemic). If we need to wait for NMRR ID prior to submission to NPRA, there may be long delay as we need to have a complete EC package submitted first (i.e. translations, IAHODIA forms etc). Are there any options to expedite this administrative step?

Effective from 1st April 2023, to streamline with the amendment on the requirements for Conditional Registration of Pharmaceutical Products During Disaster dated 20th June 2022 (Section 5b: Eligibility Conditions), for Investigational Products (IP) in COVID-19 Trials with the following characteristics can be considered for Fast Track Reviews:

 

Therapeutic product with new active ingredient(s) and a different mechanism of action or a new vaccine with a different platform that has not been registered in Malaysia (either via full registration or via conditional registration). In addition, the said product should have as good as or compelling efficacy and/or safety profiles compared to current existing registered products.

2. Post Movement Control Order (MCO), do we need to submit all submissions made via email to NPRA again in paper format?

C) Investigational Product (IP) Direct to Patients (DTP)

1. Do we need to obtain Clinical Trial Import License (CTIL) or any special approval from NPRA when importing study drug from Singapore for the Malaysian patient who is participating in a trial in Singapore?
Every Clinical Trial Import License (CTIL) approvals from NPRA are under the presumption that the Investigational Product (IP) will be administered or dispensed to Malaysian patients at a clinical trial site in Malaysia since the respective clinical trial was approved by the Malaysian ethics committee. Therefore to maintain the trial’s integrity, IP sharing between countries is not recommended.

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


Below are additional comments from Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) Section for further consideration:
NPRA recognise that the supply of IP 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 Clinical Trial Import License (CTIL) / Clinical Trial Exemption (CTX) with an approved import quantity.
• Sponsor shall only distribute the IP on Malaysian sites to trial subjects.
• The direct-to-patient (DTP) delivery of IP 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 IP to trial subject or their relative. In other words, the sponsor need to deliver the IP 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 IP in a suitable way.
• Dispatch of the IP 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.
2. Is it required to notify NPRA at each instance when Investigational Product (IP) is to be shipped from depot (sponsor) or investigator site directly to the patient?
3. How will Investigational Product (IP) accountability be tracked (or linked back to the Site-Specific Approval of IP quantity) as the proforma invoice will no longer state the site name, instead it will be the address of the patient. In this case, sponsor/CROs are not allowed to keep a copy on the proforma invoice for submission to NPRA at the end of the study (patient confidentiality will be compromised), so should accountability per NPRA’s requirement be performed?

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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