MINISTRY OF HEALTH MALAYSIA MALAYSIAN NATIONAL …
MINISTRY OF HEALTH MALAYSIA
MALAYSIAN NATIONAL MEDICINES POLICY
2nd Edition, 2012 DASAR UBAT NASIONAL (DUNas) EDISI KEDUA, 2012
Ministry of Health Malaysia
MALAYSIAN NATIONAL MEDICINES POLICY
2nd Edition, 2012
First print 2013 ? Malaysian National Medicines Policy (MNMP) 2013
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without prior permission in writing.
ISBN 978-967-5570-44-5
9 789675 570445
CONTENTS
MINISTRY OF HEALTH MALAYSIA
MALAYSIAN NATIONAL MEDICINES POLICY
CONTENTS
ACKNOWLEDGEMENTS
iii
PREAMBLE
1
INTRODUCTION
1
1. GOVERNANCE IN MEDICINES
4
1.1 AIM
5
1.2 STRATEGY
5
2. QUALITY, SAFETY AND EFFICACY OF MEDICINES
6
2.1 AIM
7
2.2 STRATEGY
7
2.2.1 LEGISLATION AND REGULATIONS
7
2.2.1.1 National Pharmaceutical Control Bureau (NPCB)
7
2.2.1.2 Regulating Premises that Supply Medicines
8
2.2.1.3 Effective Enforcement
8
2.2.1.4 Medicines Advertisement and Promotion
8
2.2.1.5 Counterfeit Medicines
8
2.2.2 PHARMACEUTICAL QUALITY ASSURANCE
9
2.2.2.1 Post-Marketing Surveillance
9
2.2.2.2 Management of Complaints about Medicines
9
3. ACCESS TO MEDICINES
10
3.1 AIM
11
3.2 STRATEGY
11
3.2.1 AVAILABILITY OF MEDICINES
11
3.2.1.1 Selection of Medicines
11
3.2.1.1.1 National Medicines Formulary
11
3.2.1.1.2 National Essential Medicines List (NEML)
12
3.2.1.1.3 Drug and Therapeutic Committee
12
3.2.1.1.4 Traditional and Complementary Medicines Formulary
12
3.2.1.1.5 Life-saving Medicines and Orphan Medicines
12
3.2.1.1.6 Halal Medicines
13
3.2.1.2 Supply of Medicines
13
3.2.1.2.1 Procurement
13
3.2.1.2.2 Distribution and Storage of Medicines
13
3.2.1.2.3 Disposal of Medicines
13
3.2.1.2.4 Medicines Supply in Emergency Situations and Medicines 13 Donations
i
MINISTRY OF HEALTH MALAYSIA
MALAYSIAN NATIONAL MEDICINES POLICY
MINISTRY OF HEALTH MALAYSIA
3.2.2 AFFORDABILITY OF MEDICINES
14
3.2.2.1 National Pricing Reference for Medicines
14
3.2.2.1.1 Transparency on Price Information
14
3.2.2.1.2 Monitoring of Price Information
14
3.2.2.1.3 Tariffs and Duties
14
3.2.2.2 Financing for Medicines
15
3.2.2.3 Generic Medicines Policy
15
4. QUALITY USE OF MEDICINES
16
4.1 AIM
17
4.2 STRATEGY
17
4.2.1 DEVELOPMENT AND IMPLEMENTATION OF MODELS OF BEST PRACTICE 17
4.2.2 EDUCATION AND TRAINING
18
4.2.2.1 Healthcare Providers
18
4.2.2.2 Consumers
18
4.2.2.3 Pharmaceutical Industry
18
4.2.2.4 Media
18
4.2.3 PROVISION OF TIMELY AND ACCURATE INFORMATION ON MEDICINES 18
4.2.3.1 Healthcare Providers
18
4.2.3.2 Consumers
19
4.2.3.3 Pharmaceutical Industry
19
4.2.3.4 Media
19
4.2.4 STRENGTHENING SEAMLESS CARE BETWEEN HEALTHCARE
19
PROVIDERS
4.2.5 RESEARCH AND DEVELOPMENT IN QUALITY USE OF MEDICINES
19
4.2.6 ENGAGEMENT OF PAYERS INVOLVED IN REIMBURSEMENTS FOR
19
MEDICINES USE
5. PARTNERSHIP AND COLLABORATION FOR THE HEALTHCARE INDUSTRY
20
5.1 AIM
21
5.2 STRATEGY
21
5.2.1 HUMAN RESOURCE DEVELOPMENT
21
5.2.2 RESEARCH AND DEVELOPMENT
22
5.2.3 TECHNICAL COLLABORATION AND PARTNERSHIP
22
5.2.4 A VIABLE AND RESPONSIBLE PHARMACEUTICAL INDUSTRY
22
5.2.4.1 Domestic Pharmaceutical Manufacturing
23
GLOSSARY
24
ABBREVIATIONS
29
MINISTRY OF HEALTH MALAYSIA
ii
MINISTRY OF HEALTH MALAYSIA
MALAYSIAN NATIONAL MEDICINES POLICY
ACKNOWLEDGEMENTS
The Pharmaceutical Services Division (PSD) of the Ministry of Health would like to thank the World Health Organization (WHO) for its contribution in making the full-term review of the Malaysian National Medicines Policy a successful effort.
The PSD would also like to express appreciation to the following participants and stakeholders for their support and contribution in the preparation of this policy:
? Pharmaceutical Services Division, State Health Departments ? National Pharmaceutical Control Bureau ? Medical Practice Division, Ministry of Health ? Medical Development Division, Ministry of Health ? Planning and Development Division, Ministry of Health ? Finance Division, Ministry of Health ? Oral Health Division, Ministry of Health ? Procurement and Privatisation Division, Ministry of Health ? Family Health Development Division, Ministry of Health ? Traditional and Complementary Medicine Division, Ministry of Health ? Health Education Division, Ministry of Health ? Clinical Research Centre, Ministry of Health ? Policy and International Relations Division, Ministry of Health ? Human Resource Division, Ministry of Health ? Institute for Health System Research, Ministry of Health ? National Institute of Health, Ministry of Health ? Health Services Division of the Malaysian Armed Forces HQ, Ministry of Defence ? Educational Policy Planning and Research Division, Ministry of Education ? Ministry of International Trade and Industry ? Ministry of Science, Technology and Innovation ? Performance Management Delivery Unit, Prime Minister's Department (PEMANDU) ? University of Malaya (UM) ? Universiti Sains Malaysia (USM) ? National University of Malaysia (UKM) ? International Islamic University Malaysia (IIUM) ? University Technology MARA (UiTM)
iii
MINISTRY OF HEALTH MALAYSIA
MALAYSIAN NATIONAL MEDICINES POLICY
MINISTRY OF HEALTH MALAYSIA
? International Medical University (IMU) ? University of Nottingham Malaysia Campus ? Pharmacy Dean Council ? University Malaya Medical Centre (UMMC) ? UKM Medical Centre (UKMMC) ? Malaysian Medical Association (MMA) ? Malaysian Pharmaceutical Society (MPS) ? Malaysian Academy of Pharmacy ? Malaysian Organisation of Pharmaceutical Industries (MOPI) ? Pharmaceutical Association of Malaysia (PhAMA) ? Malaysian Association of Pharmaceutical Suppliers (MAPS) ? Association of Private Hospitals Malaysia (APHM) ? Consumer Association of Penang (CAP) ? Federation of Malaysian Consumers Associations (FOMCA) ? Malaysian Investment Development Authority (MIDA) ? Malaysia Competition Commission (MyCC) ? Intellectual Property Corporation of Malaysia (MyIPO) ? Forest Research Institute Malaysia (FRIM) ? Malaysia Biotechnology Corporation Sdn. Bhd. ? General Insurance Association of Malaysia (PIAM) ? Direct Selling Association of Malaysia (DSAM) ? Pharmacists and medical doctors from public and private hospitals
MINISTRY OF HEALTH MALAYSIA
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