New Chemical Entity Products, Herbal Products with Therapeutic Claims and Biologic Products (except Cell and Gene Therapy Products).

The use of an investigational product after the trial has ended will be under compassionate use program. The specialist can apply for named patient basis application to Bahagian Amalan & Perkembangan Farmasi. The applicant is required to submit justification, official offer letter from the sponsor on the compassionate use program and other necessary documents.

Please find below contact details of the officer in charge:

Dr. Nur Sufiza binti Ahmad, Timbalan Pengarah Gred UF54

Cawangan Pengurusan Formulari

Bahagian Amalan & Perkembangan Farmasi

nursufiza@moh.gov.my

03-7841 3378

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.  

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.

Effective from 1st April 2023, to streamline with the amendment on the requirements for Conditional Registration of Pharmaceutical Products During Disaster dated 20^th 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.

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.

Direct-to-Patients (DTP) during COVID-19 pandemic is allowed. Initial notification of DTP to NPRA is required. Notification is not required for each shipment. However, this record should be documented in the IP accountability report.

If there is concern about risk of exposure to COVID-19, DTP delivery of IP that would not raise any new safety risks may be implemented to protect patients from coming to clinical trial sites. In all cases, requirements under Malaysian regulations for maintaining required IP storage conditions and IP accountability remain. These event must be addressed and documented.

If the approved protocol indicates IP are supplied at clinical trial site for self-administration at home, and this is changed to DTP delivery, then a protocol amendment would be required to permit home delivery of IP. If the extent of home delivery is limited to certain participants and not the entire population described in the protocol, documenting the change in the mechanisms of distribution of IP administration through protocol deviations may also be acceptable.