How Clinical Research Is

Regulated in Malaysia

DISCLAIMER

The following information are the personal views of the presenter and do not represent the views or opinions of the Ministry of

Health nor the National Clinical Research Centre

Acknowledgement to Dr Ho

Tze Ming, for preparation of

the core contents of this

presentation

PURPOSE

To inform researchers that the conduct of clinical research in MOH and Malaysia is tightly regulated. Understanding these regulations will assure speedy approval, uninterrupted conduct, and efficient dissemination of findings

CONTENTS

1. Definitions

2. Submission and approval of research proposals

3. Scientific / technical evaluation

4. Ethics

5. Regulatory

6. Quality control

7. Intellectual property rights

DEFINITIONS

DEFINITIONS

• Law: the system of rules of a country or community which it may enforce by the imposition of penalties; not applicable outside the country

• Guideline: a general rule, principle, or piece of advice

• Regulation: a rule made and maintained by an authority within context of the applicable law

• Directive: an official instruction from an authority within an organization

• Instruction: detailed information about how something should be done or operated

SUBMISSION AND APPROVAL OF

RESEARCH PROPOSALS

Submission and approval of research

proposals KPK directive on approval process: Surat Pekeliling KPK

Malaysia bil 9/2007: NIH Guidelines for Conducting Research in Ministry of Health Institutions and Facilities

• All research must go through formal channels of approval

• All research must be registered in NMRR (www.nmrr.gov.my)

• Research involving human subjects must be approved by MREC

• Publication of research findings must be approved by the DG. Need to register in NMRR.

• Dissemination of research findings in any format must be approved by the DG

Submission and approval of research

proposals

KPK directive on approval process: Surat KPK Malaysia bil KKM-5/BPF/401/007/02(3): Keperluan Penyelidik Mengikut Kursus/Latihan GCP Yang Diperakui Oleh NCCR, KKM

• Pihak Berkuasa Kawalan Dadah ingin menegaskan kegagalan penyelidik-penyelidik menghadiri kursus/latihan GCP akan menyebabkan CTIL dan/atau CTX bagi penyelidikan klinikal yang berkaitan ubat-ubatan tidak akan dikeluarkan oleh PBKD walau pun jawatankuasa etika telah meluluskan penyelidikan klinikal berkaitan.

Submission and approval of research

proposals

Instruction of Funding agencies / sponsors provides information on:

– Purpose of grants; Priority or focus areas; Funding mechanism; Allowable expenditures; Application forms or formats; Intellectual property rights; Submission process; Deadlines and timelines, Contracts; etc

SCIENTIFIC / TECHNICAL

EVALUATION

Scientific / Technical Evaluation

Why is scientific evaluation necessary?

(ICH-GCP 1996, para 2.5; Declaration of Helsinki 2013, para 21; CIOMS 2002, Guideline 1)

Scientifically valid design ensures research outcomes are accurate and reproducible

Human subjects should not be exposed to unnecessary harm or placed at risk of potential harm without some possible social or scientific benefit from the research

Scientific / Technical Evaluation

Scientific evaluation must always precede ethical review

• In-MOH vetting for all MOH research:

– Preliminary scientific and funding evaluation by relevant NIH institute (and HCRCs)

– Ethical evaluation by MREC

– NIH grant application assessed by NIH Committee

– Use of lab animals evaluated by ACUC IMR

Scientific / Technical Evaluation

• In-MOH vetting (cont..)

– National Committee on Research and Development of Herbal Medicines;

– National Stem Cell Research and Ethics Sub-Committee;

– Medical Device Authority

• External vetting:

– Genetic Modification Advisory Committee; etc

• Grant agencies have own evaluation processes.

ETHICS

Ethics

All research involving human subjects must be approved by an appropriate Ethics Committee

Protocol and Informed consent form must be

approved by a research ethics committee before the study begins

Ethics

What guides the MREC in carrying out its responsibilities?

• Declaration of Helsinki

• ICH-GCP, Malaysian GCP

• National Guidelines

• KPK directives

• MREC SOPs and policies

REGULATORY

Regulatory

Drug Control Authority, National Pharmaceutical Control Bureau

• Control of Drugs and Cosmetics Regulations 1984

• The Poison Regulations (Psychotropic Substances) 1989

• Sale of Drugs Act 1952

DCA

Control of Drugs and Cosmetics Regulations 1984 (Revised 2006)

• Part III Regulation 7.

– (1) No person shall manufacture, sell, supply, import or possess or administer any product unless

• (a) the product is a registered product; and

• (b) the person holds the appropriate license required and issued under these Regulations

DCA

Control of Drugs and Cosmetics Regulations 1984 Regulation (15) Exemptions

• Regulation 15(5) : Clinical Trial Exemption (CTX)

– “Any person who wishes to manufacture any products solely for the purpose of producing samples for registration/clinical trials under these Regulations may on application be exempted by the Authority from the provisions of regulation 7(1).”

DCA

Control of Drugs and Cosmetics Regulations 1984

• Regulation 12(1)(c): Clinical Trial Import License (CTIL)

– A Clinical trial import license in Form 4 in the Schedule,

• Authorizing the licensee to import any product for purposes of clinical trials,

• notwithstanding that the product is not a registered product

DCA

Arahan di bawah Peraturan 29, Peraturan-Peraturan Kawalan Dadah dan Komestik 1984 – Arahan Pengarah Perkhidmatan Farmasi CTI-2009

• Pihak Berkuasa Kawalan Dadah (PBKD) juga telah mewajibkan pendaftaran di NMRR bagi semua penyelidikan klinikal yang melibatkan ubat-ubatan yang memerlukan Lesen Impot Penyelidikan Klinikal (CTIL) dan Kelulusan Untuk Mengilang (CTX). Arahan ini telah dikuatkuasakan pada 1 Januari 2010.

Regulatory

Biosafety Act 2007 - Research involving LMOs (living modified organisms)

• Purpose: avoid harm to human health and environment via the use or release of products of biotechnology into the environment.

• Two different scopes of activities:

– Release activities and importation. (Release activities involve research and development (R&D) purposes in all field experiments; placing in the market; offer as gift, prize or free item, disposal and remediation purpose)

– Contained use and exportation.

Biosafety Act 2007

• NBB (National Biosafety Board) is responsible to make decisions pertaining to the release, importation, exportation and contained use of any living modified organism (LMO) derived from modern biotechnology.

• GMAC (Genetic Modification Advisory Committee) provides scientific and technical advice to the NBB.

Regulatory

Personal Data Protection Act (PDPA) 2010

• Purpose: To regulates the processing of personal data of individuals involved in commercial transactions by data users so as to provide protection to the individual’s personal data.

• Personal data includes the following:

– Name, passport/identity card number, telephone number, photograph, fingerprint, DNA ,etc.

• Act does not apply to Federal and State government activities

Regulatory

Medical Device Act 2010

• Purpose: to register and regulate medical devices placed in the market (exclude devices made available for use in clinical research)

• Definition of Medical device: Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article to be used for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of diseases and conditions

Regulatory

Medical Device Act 2010 (cont..)

• Registration is the responsibility of manufacturer

• (MREC refers studies on experimental devices to MDA for scientific expert opinion)

• Researcher may be prosecuted if knowingly uses an unregistered device that is not made available in the country solely for research

Regulatory

Surat Pekeliling Am 3/1999: Regulations for conduct of research in Malaysia

• Purpose: to expedite and co-ordinate research conducted in Malaysia by foreign researchers and Malaysian nationals from institutions and/or organization overseas.

• EPU is the coordinating agency

– application on form available from Malaysian embassy or high commission

– Research must be in collaboration with a Malaysian counterpart

– Comments of relevant ministries or agencies obtained before decision on approval

QUALITY CONTROL / ASSURANCE

Quality Control / Assurance

Why need QC/QA?

To ensure reproducibility, reliability and accuracy of research findings

Quality Control / Assurance

• Ethics – ICH-GCP, Malaysian GCP

• Management – ISO 9001:2007

• Data – ISO 17025 – quality system for testing and calibration

laboratories – GLP (Accreditation by OECD, NATA, etc) - quality assurance

and data integrity in support of the approval for regulated products (e.g. Pharmaceuticals); Standards Malaysia appointed as National Compliance Monitoring Authority

• Product – GMP (Accreditation by FDA, EMEA)

INTELLECTUAL PROPERTY RIGHTS

Intellectual Property Rights

• Dissemination of research findings

– Surat Pekeliling KPK Malaysia bil 9/2007, 5 September 2007:

o 2.4 Publication of findings must be approved by DG. Register in NMRR.

o 2.5 Dissemination of findings through publication, reports, presentations, advertisements, public media, must be approved by DG

Intellectual Property Rights

• Authorship in publications by MOH researchers – Surat Pekeliling KPK Malaysia bil 6/1993, 1

November 1993: o 3.1 Inclusion as an author must be based on

contribution to (a) the concept, planning , design, analysis or interpretation of findings; or (b) the preparation or review of manuscript for publication of the research findings. Involvement in the obtaining of research funds, collection of data, or general supervision of the research team, does not merit authorship

Intellectual Property Rights

• Patents – Patents Act 291 1983; Patents (Amendment) Acts

1993, 2000, 2002, 2003, 2006; Patents Regulations 1986; Patents (Amendment) Regulations 1993.

• Copyrights – Copyright Act 332 1987, Copyright (Amendment)

Act A1139 2002

• Trade Marks – Trade Marks Act 1976; Trade Marks (Amendment)

Acts 1994, 2000, 2002;Trade Marks Regulations 1997

SUMMARY

• Have discussed various types of regulations that regulate (a) the conduct of research in MOH and (b) the dissemination of research findings.

• Abide by these regulations to avoid delays in research approval and conduct, and penalties that may impact on future research applications and professional development.

TERIMA

KASIH

THANK YOU X