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General Clinical Trial

01 What is the regulatory authority with oversight for clinical trial in Malaysia?
Malaysia has a single regulatory authority, the National Pharmaceutical Control Bureau (NPCB). For more details, please click here. The Centre for Investigational New Product is the unit in charge.
02 What are the current regulatory authority procedure/process/flow to obtain approval to conduct clinical research with a new investigational drug?
A sponsor or CRO without an office in Malaysia can outsource this service to any of the local / international CROs or SMO. You can email at contact@crm.gov.my for this list. The SOPs and guidelines are available athere.
03 What documents are required to accompany the submission?
  • CTIL (form BPFK 442) or CTX (form BPFK 443);
  • 2 copies of application submission form (form BPFK 001);
  • 2 copies submission checklist (form BPFK 002.5);
  • Processing fee;
  • Company registration certificate;
  • Copy of Applicant’s License A;
  • Letter of Authorisation if application service is outsourced;
  • Ethics approval letter;
  • GCP certificate of each Site Investigator;
  • GMP certificate/statement;
  • Study Protocol;
  • ICF initial version);
  • Pharmaceutical data and IB.
04 Who is responsible for the application?
A representative from the sponsor or CRO.
05 What is the time frame for approval (approval letter, email, etc)?
Completed application without queries can be approved within 30 working days.
06 Is there a fee for clinical trial application?
The processing fee is RM500 per product.
07 Can all submission tasks be performed by the CRA?
Yes. The Application Form must be signed by a License A holder for ‘poison / drug’. Holder of the CTIL/CTX need not necessarily be the one who conducts the trial.
08 What are the IRB/IECs in Malaysia?
There are 13 IRBs/IECs in Malaysia registered with the NPCB. These include the Ministry of Health Medical Research and Ethics Committee (MOH MREC), the Penang Ethics Committee and ethics committees from universities and private hospitals. Clinical trials conducted at these sites have to be approved by the respective IRB/IEC.
09 Does the MOH Hospital sites in each State require different MOH MREC approval?
The MOH hospital sites have only one central IRB that is the MOH MREC. Applications can be submitted online via the National Medical Research Register. For more details, please click here.
10 Must all principal investigators and sub-investigators be registered with the NMRR?
Yes
11 What if a principal investigator is not registered in NMRR- can the CRA register for him?
Yes, the principal investigator can then change the password.
12 Can we submit the hardcopy documents to MOH MREC if the sponsor does not allow online submission for certain study documents e.g. IB?
You can e-mail a request to the MREC Secretariat at nihsec@nih.gov.my .
13 If we need to add a new site after the MOH MREC approval, is this to be submitted online as well?
Yes.
14 After MOH MREC has approved the study, how do we submit protocol amendment, additional study documents, etc –can these be submitted online?
Yes.
15 What is the approval timeline?
Complete submission without queries can be approved within 4 to 8 weeks.
16 Should a CRA have any questions while performing the online submission, who should he/she contact?
The CRA can contact MOH Research Ethics Committee (MREC)/MOH Research Grants (MRG) / Publication NIH Secretariat Ministry of Health Malaysia, c/o Institute for Health Management, Jalan Rumah Sakit, Bangsar, 50900 Kuala Lumpur.Phone: 03-2282 9082 / 03-2282 9085 / 03-2287 4032 Fax: 03 – 2287 4030 Email: nihsec@nih.gov.my Website: www.nih.gov.my
17 How often are the IRB/IEC meetings?
The MOH MREC sits twice a month. You can view the annual schedule at here.
18 Is there a fee for the EC review process?
None at the moment.
19 Does the ethics committee have general SOPs / Guidelines / Checklist / Templates available?
You can download the MOH MREC research guidelines at here.
20 Does the ICF need to be in different languages?
The ICF has to be in English, Bahasa Malaysia, Mandarin and Tamil (where required).
21 Are there any specific regulations with respect to transport of biological specimen or sputum?
Yes, and you can find the Guideline at here.