ACTD GUIDELINES FOR GENERIC PRODUCT
ACTD GUIDELINESFOR GENERIC PRODUCT1Prepared by AliACTDASEAN
abbreviates Association of South East Asian Nations.
Established in 08 August 1967
Ten (10) Member states are Brunei, Cambodia, Indonesia, Lao,
Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam.
Prepared by International Marketing18 November 2015Prepared by
Ali2ORGANIZATION OF ACTDACTD documents comprises following
parts;
PART I: Table of contents, Administrative Data & Product
Information(Applicable)
PART II: Quality Documents(Applicable)
PART III: Non Clinical Documents(Not Applicable for generic
products)
PART IV: Clinical Documents(Not Applicable for generic products
some exception may apply)Prepared by International Marketing18
November 2015ORGANIZATION OF ACTD.ContPart I : Table of Content
Administrative Information and Prescribing InformationSection A:
IntroductionSection B: Overall ASEAN Common Technical Dossier Table
of ContentsSection C: Documents required for registration (for
example, application forms,labeling, Product Data Sheet,
prescribing information)Part II : Quality DocumentSection A: Table
of ContentsSection B: Quality Overall SummarySection C: Body of
DataPrepared by International Marketing18 November 2015ORGANIZATION
OF ACTD contPart III : Nonclinical DocumentSection A: Table of
ContentsSection B: Nonclinical OverviewSection C: Nonclinical
Written and Tabulated Summaries1. Table of Contents2.
Pharmacology3. Pharmacokinetics4. ToxicologySection D: Nonclinical
Study Reports1. Table of Contents2. Pharmacology3.
Pharmacokinetics4. Toxicology
Prepared by International Marketing18 November 2015ORGANIZATION
OF ACTD.ContPart IV : Clinical DocumentSection A: Table of
ContentsSection B: Clinical OverviewSection C: Clinical Summary1.
Summary of Biopharmaceutics and Associated Analytical Methods2.
Summary of Clinical Pharmacology Studies3. Summary of Clinical
Efficacy4. Summary of Clinical Safety5. Synopses of Individual
StudiesSection D: Tabular Listing of All Clinical StudiesSection E:
Clinical Study ReportsSection F: List of Key Literature
References
Prepared by International Marketing18 November 2015Module
1Application form1Letter of authorizationCertificationsManufacturer
LicenseGMP CertificateCOPPSite Master File LabelingProduct
Information Package InsertSummary of Product CharacteristicsPatient
Information Leaflet Prepared by International Marketing18 November
2015Module 2Quality overall SummaryBody of dataDrug
SubstanceGeneral InformationManufactureCharacterizationControl of
Drug substanceReference standard or materialsContainer Closure
systemStabilityDrug ProductDescription and
CompositionPharmaceutical DevelopmentManufacture
Prepared by International Marketing18 November 2015Module
2..ContControl of ExcipientControl of Finished ProductsReference
Standard or materialsContainer Closure systemStability Product
Interchangeability (Comparative Dissolution)
Prepared by International Marketing18 November 2015Module
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.
REFRENCE: ACTD Guidelines Prepared by International Marketing18
November 2015Module 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.
REFRENCE: ACTD Guidelines
Prepared by International Marketing18 November 2015List of
Documents RequiredList of documents required for Part I
Administrative section writing:1. Application form (details to be
filed in)2. Letter of Authorization3. Certifications i.
Manufacturing license ii. Certificate of Pharmaceutical Product
iii. GMP certificate of the Manufacturer iv. Site Master File of
manufacturer
Prepared by International Marketing18 November 2015List of
Documents RequiredCont4. Labeling i. Mock-up for Inner Carton ii.
Mock-up for outer carton iii. Mock-up for Label5. 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)PIL is required for
Over-the-Counter Products ProductInformation
Prepared by International Marketing18 November 2015List of
Documents RequiredContList of documents required for Part II
Quality section writing:1. DMF of API2. BMR Finished product3. BPR
Finished product4. Critical manufacturing steps and
justifications5. Process validation protocol and report6. Flow
chart (Detailed and simple)7. Process development report8. Impurity
profile with justificationsPrepared by International Marketing18
November 2015List of Documents RequiredCont9. Excipient details
:Specification and testing methodCOATSE/BSE declaration from
supplier/manufacturer.10. Specification and method of Analysis
(MOA)Intermediates and in-process specification & MOAFinished
product release specification & MOAFinished product Stability
specification & MOAAPI specification & MOA from finished
product manufacturer.Packaging material (primary, secondary and
tertiary)Prepared by International Marketing18 November 2015List of
Documents RequiredCont11. Analytical method validations at release
and stability (if different methods are used)AssayRelated
substanceDissolution (if applicable)Preservative content (if
applicable)Sterility (if applicable)Endotoxin (if
applicable)MLTForced degradationPrepared by International
Marketing18 November 2015List of Documents RequiredCont12. COAsAPI
(3 consecutive batches) from FP manufacturerAll the raw material
(excipients and coating materials)Reference and working
standardsImpurity standardsPackaging material (primary, secondary
and tertiary)13. IR spectra of PVC/PVDC sheets and aluminum foil if
used14. Soft copy of labels (PDF)15. Food grade certificate from
primary packaging material manufacturer for its primary packaging
materialPrepared by International Marketing18 November 2015List of
Documents RequiredCont16. Preparation of reference standard in
brief17. Stability protocol18. Stability data and Photo stability
data (if applicable)19. Bioequivalence studyPrepared by
International Marketing18 November 2015Prepared by Ali18
