Overview of ACTD Guidelines for Generic Product Registration in ASEAN
The ASEAN Common Technical Dossier (ACTD) provides guidelines for generic product registration in ASEAN member states, outlining the organization and structure of documents required for submission. The ACTD consists of various parts such as administrative data, quality documents, non-clinical documents, and clinical documents. Each part serves a specific purpose in the registration process, ensuring compliance with regulatory standards. Understanding the organization of the ACTD is crucial for a successful generic product registration in the ASEAN region.
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ACTD GUIDELINES FOR GENERIC PRODUCT
ACTD ASEAN abbreviatesAssociation of South EastAsian Nations. Established in 08August 1967 Ten (10) Member states are Brunei, Cambodia, Indonesia, Lao, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam.
ORGANIZATION OF ACTD ACTD documents comprises following parts; PART I: Table of contents,Administrative Data & Product Information(Applicable) PART II: Quality Documents(Applicable) PART III: Non Clinical Documents(NotApplicable for generic products) PART IV: Clinical Documents(NotApplicable for generic products some exception may apply)
ORGANIZATION OF ACTD .Cont Part I : Table of ContentAdministrative Information and Prescribing Information SectionA: Introduction Section B: OverallASEAN Common Technical Dossier Table of Contents Section C: Documents required for registration (for example, application forms, labeling, Product Data Sheet, prescribing information) Part II : Quality Document SectionA: Table of Contents Section B: Quality Overall Summary Section C: Body of Data
ORGANIZATION OF ACTD cont Part III : Nonclinical Document Section A: Table of Contents Section B: Nonclinical Overview Section C: Nonclinical Written and Tabulated Summaries 1. Table of Contents 2. Pharmacology 3. Pharmacokinetics 4. Toxicology Section D: Nonclinical Study Reports 1. Table of Contents 2. Pharmacology 3. Pharmacokinetics 4. Toxicology
ORGANIZATION OF ACTD .Cont Part IV : Clinical Document Section A: Table of Contents Section B: Clinical Overview Section C: Clinical Summary 1. Summary of Biopharmaceutics and Associated Methods 2. Summary of Clinical Pharmacology Studies 3. Summary of Clinical Efficacy 4. Summary of Clinical Safety 5. Synopses of Individual Studies Section D: Tabular Listing ofAll Clinical Studies Section E: Clinical Study Reports Analytical Section F: List of Key Literature References
Module 1 Application form1 Letter of authorization Certifications Manufacturer License GMP Certificate COPP Site Master File Labeling Product Information Package Insert Summary of Product Characteristics Patient Information Leaflet
Module 2 Quality overall Summary Body of data Drug Substance General Information Manufacture Characterization Control of Drug substance Reference standard or materials Container Closure system Stability Drug Product Description and Composition Pharmaceutical Development Manufacture
Module 2..Cont Control of Excipient Control of Finished Products Reference Standard or materials Container Closure system Stability Product Interchangeability (Comparative Dissolution)
Module 3..(Not Applicable) The document of this part is not required for generic product, minor variation product and some major variation product. For ASEAN member countries, the study reports of this part may not be required for NCE, Biotechnological product and some major variation products. if the original products are already registered and approved for market authorization in reference countries.
Module 4..(Not Applicable) In the ASEAN region for filing of Generic Drug their main emphasis on quality document. They permit the official research article related to drug product in clinical Data and literature references.
List of Documents Required List of documents required for Part I Administrative section writing: 1. Application form (details to be filed in) 2. Letter ofAuthorization 3. Certifications i. Manufacturing license ii. Certificate of Pharmaceutical Product iii. GMP certificate of the Manufacturer iv. Site Master File of manufacturer
List of Documents Required Cont 4. Labeling i. Mock-up for Inner Carton ii. Mock-up for outer carton iii. Mock-up for Label 5. Product Information i. Package Insert ii.Summary of Product Characteristics (Product Data Sheet) Summary of Product Characteristics is required for NCE and Biotechnology products. iii. Patient Information Leaflet (PIL) PILis required for Over-the-Counter Products Product information
List of Documents Required Cont List of documents required for Part II Quality section writing: 1. DMF ofAPI 2. BMR Finished product 3. BPR Finished product 4. Critical manufacturing steps and justifications 5. Process validation protocol and report 6. Flow chart (Detailed and simple) 7. Process development report 8. Impurity profile with justifications
List of Documents Required Cont 9. Excipient details : Specification and testing method COA TSE/BSE declaration from supplier/manufacturer. 10. Specification and method ofAnalysis (MOA) Intermediates and in-process specification & MOA Finished product release specification & MOA Finished product Stability specification & MOA API specification & MOAfrom finished product manufacturer. Packaging material (primary, secondary)
List of Documents Required Cont 11.Analytical method validations at release and stability (if different methods are used) Assay Related substance Dissolution (if applicable) Preservative content (if applicable) Sterility (if applicable) Endotoxin (if applicable) MLT Forced degradation
List of Documents Required Cont 12. COA s API (3 consecutive batches) from FP manufacturer All the raw material (excipients and coating materials) Reference and working standards Impurity standards Packaging material (primary, secondary and tertiary) 13.IR spectra of PVC/PVDC sheets and aluminum foil if used 14. Soft copy of labels (PDF) Food grade certificate from primary packaging material manufacturer for its primary packaging
List of Documents Required Cont 16. Preparation of reference standard in brief 17. Stability protocol 18.Stability data and Photo stability data (if applicable) 19. Bioequivalence study
