Adverse Drug reaction Reporting & Safety Updates
Serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Causality assessment and determination of expectedness are needed for a decision on whether or not expedited reporting is required. Term “reasonable causal relationship” can be used to convey in general that there are evidences or arguments to suggest a causal relationship.
CIOMS-I form is a widely accepted standard for expedited adverse reaction reporting. In cases of trials lasting for more than six months, an interim report shall be submitted at six-monthly intervals.
Expedited report is submitted for cases:
1. Single Cases of Serious, Unexpected ADRs
2. Observations. Examples:
a. For an “expected,” serious ADR, an increase in the rate of occurrence which is judged to be clinically important.
b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease.
c. A major safety finding from a newly completed animal study (such as carcinogenicity).
|Adverse events||Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|
|Adverse Drug Reactions (ADR)||Pre-approval drug: All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Marketed drug: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.|
|Unexpected Adverse Drug Reaction||An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product).|
|Serious Adverse Events||A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: * results in death, * is life-threatening, * requires inpatient hospitalisation or prolongation of existing hospitalisation, *results in persistent or significant disability/incapacity, or a congenital anomaly/birth defect.|
2. Post-Market Surveillance:
a) Product marketed must be in accordance to the standard and requirements of authority.
b) Registered products may be sampled and tested for compliance with official pharmacopoeia standards or specifications agreed by the manufacturer.
c) Product registration holder has to identify the cause of defect and actions to be taken for improvement in any case of products that are found to be not conform to the standards/specifications.
d) Product complaints: Product registration holder must notify NPCB for any product quality related problems.
e) Product recalls: Decision for recall of a product shall be made when there is or may cause potential risk to the user of the products.
- International Conference on Harmonisation (ICH) Tripartite Guideline. Guideline for Good Clinical Practices E6 (R1). 1996
- International Conference on Harmonisation (ICH) Tripartite Guideline. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A. 1994.
- International Conference on Harmonisation (ICH) Tripartite Guideline. Statistical Influences for Clinical Trials E9. 1998.
- International Conference on Harmonisation (ICH) Tripartite Guideline. Choice of Control Group and Related Issues in Clinical Trials E10. 2000.
- Drug Registration Guidance Document (DRGD). National Pharmaceutical Control Bureau. Ministry of Health, Malaysia. 2013.
- Guidelines for the Application of CTIL and CTX 5th Edition. National Pharmaceutical Control Bureau. Ministry of Health, Malaysia. 2009.