Part IV New Chemical Entity
- Product Validation
- Section A
- Section B
- Section C
- Section D
- Section E
- Section P
- Section S
- Part III
- Part IV
A : Table of Content
(Ref. SECTION E: CLINICAL STUDY REPORTS, PART IV: CLINICAL DOCUMENT of the ASEAN Common Technical Dossier [ACTD])
To provide the full clinical study reports. The ICH E3 provides guidance on the organisation of clinical study reports, other clinical data, and references within the ASEAN Common Technical Dossier (ACTD) for registration of a pharmaceutical product for human use.
Please refer:
B: Clinical Overview
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(Ref. SECTION B. CLINICAL OVERVIEW, PART IV: CLINICAL DOCUMENT of the ASEAN Common Technical Dossier [ACTD])
The Clinical Overview is intended to provide a critical analysis of the clinical data in the ASEAN Common Technical Dossier (ACTD). The Clinical Overview is primarily intended for use by regulatory agencies in the review of the clinical section of a marketing application. It should also be a useful reference to the overall clinical findings for regulatory agency staff involved in the review of other sections of the marketing application. The Clinical Overview should present the strengths and limitations of the development program and study results, analyse the benefits and risks of the medicinal product in its intended use, and describe how the study results support critical parts of the prescribing information.
Please refer:
C: Clinical Summary
(Ref. SECTION C. Clinical Summary, PART IV: CLINICAL DOCUMENT of the ASEAN Common Technical Dossier [ACTD])
The Clinical Summary is intended to provide a detailed, factual summarisation of all of the clinical information in the ASEAN Common Technical Dossier. This includes information provided in Clinical Study Reports; information obtained from any meta-analyses or other cross-study analyses for which full reports have been included in Clinical Study Reports and post-marketing data for products that have been marketed in other regions. The comparisons and analyses of results across studies provided in this document should focus on factual observations. In contrast, the ACTD Clinical Overview document should provide critical analysis of the clinical study program and its results, including discussion and interpretation of the clinical findings and discussion of the place of the test drug in the armamentarium.
Please refer:
D: Tabular Listing of all Clinical Studies
A tabular listing of all clinical studies and related information should be provided. The sequence in which the studies are listed should follow the sequence described in E: Clinical Study Reports
Please refer:
E: Clinical Study Reports
(Ref. SECTION E: CLINICAL STUDY REPORTS, PART IV: CLINICAL DOCUMENT of the ASEAN Common Technical Dossier [ACTD])
To provide the full clinical study reports. The ICH E3 provides guidance on the organisation of clinical study reports, other clinical data, and references within the ASEAN Common Technical Dossier (ACTD) for registration of a pharmaceutical product for human use.
Please refer:
F1: List of Key Literature References
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List of referenced documents, including important published articles, official meeting minutes, or other regulatory guidance or advice should be provided here. This includes all references cited in the Clinical Overview, and important references cited in the Clinical Summary or in the individual technical reports that were provided in Clinical Study Reports. Copies of referenced documents should be available upon request.
Please refer:
F2: Published Clinical Papers
Please provide the Published Clinical Papers of the pivotal studies.
F3: Periodic Safety Updates Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER).
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Please provide the latest Periodic Safety Updates Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER).
Please refer:
Malaysian Pharmacovigilance Guidelines, 2nd Edition (2016).
F4: Risk Management Plan(s)
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Please provide the local Risk Management Plan(s) for this product.
Please refer:
Malaysian Pharmacovigilance Guidelines, 2nd Edition (2016).