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2023

Determination of ethanol, isopropyl alcohol and methanol in alcohol-based hand sanitiser to ensure product quality, safety and efficacy.

Scientific Report 2023; 13, Article Number: 9478

Carbamazepine‐induced Severe Cutaneous Adverse Drug Reactions: A 21‐year comparison between children and adults in Malaysia

Clinical Pharmacology 2023; 63(10): 1126-1132 

Hearing loss and tinnitus associated with COVID-19 vaccines: An analysis from the national pharmacovigilance database in Malaysia.

Asian Pacific Journal of Tropical Medicine 2023; 16(7): 289-295

Thrombocytopenia and venous thromboembolic events after BNT162b2, CoronaVac, ChAdOx1 vaccines and SARS-CoV-2 infection: a self-controlled case series study

Scientific Reports 2023; 13, Article Number: 20471 

Regulatory Oversight of Cell and Gene Therapy Products in Malaysia.

In: Galli, M.C. (eds) Regulatory Aspects of Gene Therapy and Cell Therapy Products. Advances in Experimental Medicine and Biology, vol 1430. Springer, Cham.

National Regulatory Conference 2023 poster abstracts.

Pharmacy Research Reports Volume 6 Supplement Issue November 2023

 

2022

Pharmacokinetic–Pharmacometabolomic Approach in Early-Phase Clinical Trials: A Way Forward for Targeted Therapy in Type 2 Diabetes. 

Pharmaceutics 2022; 14: 1268.

Pharmacokinetics and Metabolomic Profiling of Metformin and Andrographis paniculata: A Protocol for a Crossover Randomised Controlled Trial. 

J. Clin. Med. 2022; 11: 3931.

Incidence of Antiseizure Medication–Induced Severe Cutaneous Adverse Reactions in Malaysia. 

The Journal of Clinical Pharmacology 2022, 62(8): 983-991

Incidence of allopurinol-induced severe cutaneous adverse drug reaction in Malaysia.

British Journal of Clinical Pharmacology 2022, 88(8): 3782-3788

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia:

A self-controlled case series study.

Vaccine 2022; 40 (32): 4394-4402

 

 

2021

Cell and gene therapy products in Malaysia: a snapshot of the industry's current regulation preparedness Cytotherapy 2021 Dec;23(12):1108-1113

Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000-2018)

Ther Innov Regul Sci.; 55(3):514-522.

 

 

2020

Allopurinol-induced severe cutaneous adverse drug reactions: Risk minimisation measures in Malaysia.

Pharmacoepidemiol Drug Saf.; 29(10): 1254– 1262. 

An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology. 

Therapeutic Innovation & Regulatory Science; 54: 1215–1224

 

 

2019

Unique product quality consideration in vaccine development, registration and new program implementation in Malaysia,

Human Vaccines & Immunotherapeutics; 16(3): 530-538

Enhancing Post-market Surveillance Through Laboratory Testing on Blue-green Algae Products in Malaysia. 

International Journal Of Biomedical And Clinical Sciences; 4(3): 82-90.

 

 

2017

Phosphodiesterase-5 inhibitors and their analogues as adulterants of herbal and food products: analysis of the Malaysian market, 2014–16,

Food Additives & Contaminants: Part A; 34(7): 1101-1109

An Update on the Registration of Biosimilars in Malaysia.

Therapeutic Innovation & Regulatory Science; 51(1): 55-59. 

A qualitative study among potential manufacturers on the development of ‘Made in Malaysia’ biological products: Challenges and proposed solutions. 

Journal of Commercial Biotechnology; 23(4): 44-61. 

 

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The members of MADRAC (Malaysian Adverse Drug Reactions Advisory Committee) are selected based on their qualifications and expertise with regard to their respective fields of practice. They serve on the Committee for a renewable period of three years.

 

MADRAC Members Session 2022 - 2024

 

Ex-officio Members:

 

YBRS. PN. ROSILAWATI BINTI AHMAD [Chairman]

Director

National Pharmaceutical Regulatory Agency (NPRA)

Ministry of Health, Malaysia

 

YBRS. DR. AZUANA BINTI RAMLI [Secretary of the Drug Control Authority (DCA)]

Deputy Director

Centre of Product & Cosmetics Evaluation

National Pharmaceutical Regulatory Agency (NPRA)

Ministry of Health, Malaysia

 

YBRS. DR. NORAIDA BT. MOHAMAD ZAINOOR [Secretary to the MADRAC]

Deputy Director

Centre for Compliance & Quality Control

National Pharmaceutical Regulatory Agency (NPRA)

Ministry of Health, Malaysia

 

Appointed Members

 

Appointed Alternate Members

 

YBRS. DR. GUNAVATHY MUTHUSAMY (2024)

Head of the Medical Department,

Consultant Endocrinologist and Internal Medicine,

Hospital Shah Alam.

  

YBHG. DATUK DR. NOEL THOMAS ROSS (2022-2023)

 

YBRS. DR. MARZILAWATI ABDUL RAHMAN

Medical Specialist,

Medical Department,

Hospital Kuala Lumpur.

 

 

 

YBRS. DR. LIZA MOHD. ISA

National Head of Rheumatology Services,

Medical Consultant (Rheumatology),

Medical Department,

Hospital Putrajaya.

 

YBRS. DR. HABIBAH MOHD YUSOOF

Head of Department and Medical Consultant (Rheumatology), 

Hospital Selayang.

 

 

 

YBRS. DR. FARAH INAZ SYED ABDULLAH

Consultant Paediatrician and Neonatologist,

Department of Paediatrics,

Hospital Tunku Azizah.

 

YBRS. DR. LIM POI GIOK

Consultant Paediatrician and Endocrinologist,

Department of Paediatrics,

Hospital Tunku Azizah.

 

YBRS. DR. MAZNI BINTI MAT JUNUS

Head of Department and Consultant Psychiatrist,

Hospital Selayang.

 

 

YBRS. DR. CHIN LOI FEI

Consultant Geriatric Psychiatrist,

Department of Psychiatry and Mental Health,

Hospital Kajang.

 

YBRS. DR. SUNITA BAVANANDAN

National Head of Nephrology Services,

Consultant Nephrologist,

Hospital Kuala Lumpur.

 

YBRS. DR. SURYATI YAKOB

Consultant Nephrologist,

Department of Nephrology,

Hospital Selayang.

 

YBRS. DR. SUGANTHI THEVARAJAH

National Head of Dermatology Services,

Head of Dermatology Department,

Hospital Kuala Lumpur.

 

YBRS. DR. TANG MIN MOON

Head of Department and Consultant Dermatologist,

Hospital Umum Sarawak.

 

 

YBRS. DR. MOHD. SAPAWI MOHAMED

Consultant Cardiologist,

Medical Department,

Hospital Raja Perempuan Zainab II.

 

YBRS. DR. SITI KHAIRANI ZAINAL ABIDIN

Head of Department and Consultant Cardiologist,

Hospital Tengku Ampuan Afzan.

 

 

YBRS. DR. VOON PEI JYE

Medical Oncologist,

Department of Radiotherapy and Oncology,

Hospital Umum Sarawak.

 

YBRS. DR. IBTISAM MUHAMAD NOR

Clinical Oncologist,

Department of Radiotherapy and Oncology,

Hospital Kuala Lumpur.

 

YBRS. PROF. MADYA DR. ADYANI MD. REDZUAN

Faculty of Pharmacy,

National University of Malaysia.

 

YBRS. DR. NORKASIHAN IBRAHIM

Faculty of Pharmacy,

MARA University of Technology

 

YBRS. DR. MOHD HANIF ZAILANI

Public Health Specialist,

Senior Principal Assistant Director,

Vaccine Prevention and Food & Water Borne Disease Sector,

Disease Control Division,

Ministry of Health, Malaysia.

 

YBRS. DR. JAMIATUL AIDA MD. SANI

Public Health Specialist,

Senior Principal Assistant Director,

Vaccine Prevention and Food & Water Borne Disease Sector,

Disease Control Division,

Ministry of Health Malaysia.

 

YBRS. DR. NUR SUFIZA BINTI AHMAD

Deputy Director,

Formulary Management Branch,

Pharmacy Practice & Development Division,

Ministry of Health, Malaysia.

 

YBRS. DR. ALIZA BINTI ALIAS

Senior Principal Assistant Director UF 54,

Pharmaceutical Care Branch,

Pharmacy Practice & Development Division,

Ministry of Health, Malaysia.

 

PN. HO WAN DIEN, JEMIMA

Malaysian Pharmaceutical Society (MPS)

 

PN. SYIREEN ALWI

Malaysian Pharmaceutical Society (MPS)

 

YBRS. DR. SIVANAESAN LETCHUMANAN

Malaysian Medical Association (MMA)

 

YBRS. DR. BALACHANDRAN A/L S. KRISHNAN

Malaysian Medical Association (MMA)

 

YBRS. DR. G. SHANMUGANATHAN

Federation of Private Medical Practitioners’

Association Malaysia (FPMPAM)

 

YBRS. DR. PEARL LEONG YUET MAE

Federation of Private Medical Practitioners’

Association Malaysia (FPMPAM)

 

PN. ELIZA BASIR

Association of Private Hospitals of Malaysia (APHM)

 

PN. ZARIHASYUM WAN ZEIN

Association of Private Hospitals of Malaysia (APHM)

 

 

Last updated: 15 March 2024 

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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