NOMINATION CRITERIA FOR THE PANEL OF EXPERT (POE) CLINICAL TRIAL IMPORT LICENCE (CTIL) AND CLINICAL TRIAL EXEMPTION (CTX)
1. The fields of expertise for the First-In-Human (FIH) Panel of Expert (POE) involved are according to the needs of the relevant FIH clinical studies:
● Pharmacology
● Toxicology
● Pharmacokinetics
● Medical Statistics
● Pharmacognosy, if applicable
● Medical Experts
2. The criteria or nominating the Panel of Experts (POE) for Medical Experts are as follows:
2.1 Consultant Specialists/ Senior Consultant Specialists from MOH, nominations may consist of DCA expert panel members as nominated by the Medical Development Division (BPP) or other relevant divisions/institutes
a) At least 1-2 specialists for each area/sub-area of expertise;
b) Must have at least 2 years of service with MOH remaining;
c) Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC)
d) Not among the members/alternate members of DCA
2.2 Consultant Specialists/ Senior Consultant Specialists from universities with teaching hospitals, and nominations will be requested from Hospital Universiti Sains Malaysia (HUSM), Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM), Pusat Perubatan Universiti Malaya (PPUM)
a) At least 1-2 specialists for each area/sub-area of expertise;
b) Must have at least 2 years of service with the Ministry of Higher Education remaining;
c) Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC);
d) Not among the members/alternate members of DCA
2.3 Consultant Specialists/ Senior Consultant Specialists from the private sector
a) At least 1-2 specialists for each area/sub-area of expertise;
b) Must possess relevant professional qualification and experience;
c) Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC);
d) Not among the members/alternate members of DCA
2.4 Consultant/ Senior Consultant who is a Malaysian Citizen currently serving abroad and meets the following criteria:
a) At least 1-2 specialists for each area of specialisation;
b) Possesses relevant professional qualtifications and experience;
c) Not a member of the Scientific Review Panel (SRP) of the Medical Research Ethics Committee (MREC);
d) Not a member or alternate member of the Drug Control Authority (DCA)
3. The criteria or nominating the Panel of Experts (POE) CTX/CTIL for the fields of Pharmacology, Toxicology, Pharmacokinetics, Medical Statistics and Pharmacognosy are as follows:
3.1 Lecturers/ Senior Lecturers from Public Universities
a) At least 1-2 specialists for each field of expertise;
b) Must have at least 2 years of service with the Ministry of Higher Education remaining;
c) Not among the Scientific Review Panel (SRP) for the Medical Research Ethics Committee (MREC);
d) Not among the members/alternate members of DCA
4. The nomination criteria for the POE Expert List for vaccine products are as follows:
4.1 Specialists appointed by the Ministry of Health Malaysia (MOH) under the Subcommittee for Vaccine Candidate Selection (JKKPCV)
5. All specialists in the POE CTX/CTIL panel are appointed by the Deputy Director General of Pharmacy Services (TKPK(PF)) for a term of 3 years.
6. The criteria or the existing POE CTX/CTIL panel nominations are based on the decisions of the following meetings:
● Product Evaluation Committee Meeting No. 14/2020, 14th December 2020
● Product Evaluation Committee Meeting No. 06/2025, 14th May 2025
To know more about the nomination process for Panel of Experts for First-In-Human, kindly contact Puan Suhailah Abu Bakar (This email address is being protected from spambots. You need JavaScript enabled to view it.) or Puan Aiza Adlina Abdullah (This email address is being protected from spambots. You need JavaScript enabled to view it.)
