Page 43 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

11. Special Regulatory Requirement(s)

11.1. National Pharmaceutical Regulatory Authority (NPRA) – Clinical Trial Research

For research involving investigational product(s) including placebo requiring CTIL and/or CTX,
the investigators or CP must apply for CTIL/CTX as per all applicable regulations by the NPRA
[29,30]. Concurrent submission and registration with NMRR and the ethical committee (MREC
in the case for MOH) are compulsory during the application for CTIL/CTX.
11.2. CKAPS (Cawangan Kawalan Amalan Perubatan Swasta) – Research Involving Private
Facilities

For research site(s) involving private medical facilities, the facilities should be registered with
CKAPS as per the regulation of the Private Healthcare Facilities & Services Act 1998 (Act 586) [31].

11.3. Medical Device Authority (MDA) – Research Involving Medical Devices
For research involving unauthorised or/and unregistered or/and unapproved use of medical
devices in Malaysia as the investigational product(s), an application should be submitted to the
Medical Device Authority (MDA) for review [32]. Letters or correspondence should be submitted
together during the research registration and ethical review and consideration application in
the NMRR.

11.4. Human Tissue and Biological Samples of Import or Export License
It is a requirement for the investigators to apply for an import or export permit for the importation
or exportation of human tissue and its biological samples for the purposes of clinical trial
and research. Human tissue and biological samples importation or exportation activities are
subjected to the governing acts and regulations as stated in the Guideline for Importation and
Exportation of Human Tissue or Its Part (Garispanduan Pengimportan Dan Pengeksportan Tisu
Manusia Atau Mana-Mana Bahagiannya) [33]. Submission for the permit can be applied via an
online application using the BLESS system at (https://www.bless.gov.my) [34].
11.5. Biosafety Act 2007, Act 678 and Biosafety Regulations 2010 - Research Involving Modern
Biotechnology and LMOs

National Biosafety Board was established under the Biosafety Act 2007, Act 678 and Biosafety
Regulations 2010 in order to regulate the release, importation, exportation and contained
use of LMOs. This is to ensure adequate protection to the entity (human, plants and animal
health, the environment and biological diversity) involved in the research whereby the risk
may be imminent and unclear [35-36]. PI should always take the responsibility to ensure all
requirements are followed during the entire conduct of the research. Notification and Approval
to conduct a Modern Biotechnology and LMOs research should be applied and obtained prior
to research commencement.

NIH Guidelines for Conducting Research in MOH, 2021 27