Preface

These guidelines have been developed to outline the requirements and procedures to be followed for submission of reports of adverse drug reactions to the Drug Control Authority (DCA).

Under current arrangements, the National Adverse Drug Monitoring Centre and the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) Secretariat are located within the National Pharmaceutical Control Bureau, which in turn acts as the Secretariat to the DCA.

Although these guidelines and certain stipulations are not obligatory, registration holders and health professionals are encouraged to comply in the spirit of cooperation towards establishing the safety profile of drugs which may be under evaluation as well as for products already registered by the DCA.

The DCA hopes that the recommendations in this document will help to improve the quality and standard of safety monitoring of products used in Malaysia.

CHE MOHD ZIN CHE AWANG
DIRECTOR, PHARMACEUTICAL SERVICES DIVISION and CHAIRMAN
MALAYSIAN ADVERSE DRUG REACTIONS ADVISORY COMMITTEE

MINISTRY OF HEALTH MALAYSIA, KUALA LUMPUR, MARCH 2002

The Malaysian Adverse Drug Reactions Advisory Committee

PART 1

1. INTRODUCTION 2. LEGAL BASIS 3. CONFIDENTIALITY 4. SCOPE OF ADR REPORTING 5. OBJECTIVES OF ADR MONITORING 6. IMPACT OF ADR MONITORING 7.      PROCEDURES FOR REPORTING 7.1.   GENERAL PRINCIPLES 7.1.1 The National Adverse Drug Reactions Monitoring Centre 7.1.2 Reporting Forms 7.1.3 Content of suspected serious ADR reports 7.1.4 Route of Notification 7.1.5 Time-lines for Reporting 7.1.6 Follow-up reports 7.2    REPORTING REQUIREMENTS IN SPECIAL SITUATIONS 7.2.1 Reporting in the period between the submission of the application and the granting of the registration 7.2.2 Reporting of outcomes of use during pregnancy and breast-feeding 7.2.3 Reporting from other post-marketing initiatives: surveys, registries 7.2.4 Compassionate use/named patient supplies 7.2.5 Lack of Efficacy Reports 7.2.6 Reporting of overdoses 7.2.7.Consumer Reports 8.      RISK - BENEFIT EVALUATION 8.1    PRINCIPLES OF BENEFIT-RISK ASSESSMENT 8.1.1 Assessment of risks 8.1.2 Assessment of benefits 8.1.3 Benefit-risk assessment 8.2    IMPROVING THE BENEFIT TO RISK BALANCE 8.3    WITHDRAWAL OF A PRODUCT FROM THE MARKET ON RISK-BENEFIT         GROUNDS 8.4    COMMUNICATION

PART 2

9.      GUIDELINES FOR REGISTRATION HOLDERS 9.1    REPORTING OBLIGATIONS 9.2    RESPONSIBILITIES OF THE REGISTRATION HOLDER 9.3    REPORTING ADRS TO THE DCA 9.3.1 Adverse Drug Reactions Occurring Within Malaysia 9.3.2 Adverse Drug Reactions Occurring Outside Malaysia 9.4    PERIODIC SAFETY UPDATE REVIEWS (PSUR) 9.5    CASE REPORTS FROM PUBLISHED SCIENTIFIC LITERATURE 9.6    REPORTS FROM POST-REGISTRATION STUDIES 9.7    ON-GOING PHARMACOVIGILANCE EVALUATION

PART 3

10.   GUIDELINES FOR REPORTING ADVERSE DRUG REACTIONS FROM       CLINICAL TRIALS 10.1 REPORTING ADVERSE REACTIONS 10.2 OTHER OBSERVATIONS 10.3 MANAGING BLINDED THERAPY CASES

PART 4

11.      GUIDELINES FOR HEALTH PROFESSIONALS 11.1    SCOPE OF ADR MONITORING 11.2    WHAT TO REPORT 11.2.1 Serious ADRs 11.2.2 Unexpected/Unlabelled ADR 11.3    CONFIDENTIALITY 11.4    ADR REPORTING MECHANISM 11.5    REPORTING FROM GOVERNMENT / PRIVATE HOSPITALS 11.5.1 Physician Reporting 11.5.2 Pharmacy Reporting 11.6    GOVERNMENT HEALTH CENTRES 11.7    PRIVATE CLINICS 11.8    RETAIL PHARMACIES

PART 5

12. BASIC PRINCIPLES OF EFFICIENT REPORTING

APPENDIXES

Appendix 1 DEFINITIONS AND TERMINOLOGY Appendix 2 TABULATED SUMMARY OF REPORTING REQUIREMENTS FOR REGISTRATION HOLDERS Post-Registration ADR Reporting Pre-Registration ADR Reporting From Clinical Studies Appendix 3 The ADR Form

(Updated: 3 July, 2008)

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