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EUROPE |
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Authority |
EMEA: European Medicines Evaluation Agency |
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website |
EUDRALEX |
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DOSSIER REQUIRMENTS |
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Module 1: Administrative Information and Prescribing Information
1.0 Cover Letter
1.1 Comprehensive Table of Contents
1.2 Application Form
1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet
1.3.2 Mock-up
1.3.3 Specimen
1.3.4 Consultation with Target Patient Groups
1.3.5 Product Information already approved in the Member States
1.3.6 Braille
1.4 Information about the Experts
1.4.1 Quality
1.4.2 Non-Clinical
1.4.3 Clinical
1.5 Specific Requirements for Different Types of Applications
1.5.1 Information for Bibliographical Applications
1.5.2 Information for Generic, ‘Hybrid’ or Bio-similar Applications
1.5.3 (Extended) Data/Market Exclusivity
1.5.4 Exceptional Circumstances
1.5.5 Conditional Marketing Authorisation
1.6 Environmental Risk Assessment
1.6.1 Non-GMO
1.6.2 GMO
1.7 Information relating to Orphan Market Exclusivity
1.7.1 Similarity
1.7.2 Market Exclusivity
1.8 Information relating to Pharmacovigilance
1.8.1 Pharmacovigilance System
1.8.2 Risk-management System
1.9 Information relating to Clinical Trials
1.10 Information relating to Paediatrics
Responses to Questions
Additional Data
Module 2: Common Technical Document Summaries
2.1 TABLE OF CONTENTS
2.2 INTRODUCTION
2.3 QUALITY OVERALL SUMMARY
2.3.S DRUG SUBSTANCE (Drug substance manufacturer)
2.3.S.1 General information
2.3.S.1.1 Nomenclature
2.3.S.1.2 Structure
2.3.S.1.3 General properties
2.3.S.2 Manufacture
2.3.S.2.1 Manufacturers
2.3.S.2.2 Description of manufacturing process and process controls
2.3.S.2.3 Control of materials
2.3.S.2.4 Controls of critical steps and intermediates
2.3.S.2.5 Process validation and/or evaluation
2.3.S.2.6 Manufacturing process development
2.3.S.3 Characterisation
2.3.S.3.1 Elucidation of structure and other characteristics
2.3.S.3.2 Impurities
2.3.S.4 Control of drug substance
2.3.S.4.1 Specification
2.3.S.4.2 Analytical procedures
2.3.S.4.3 Validation of analytical procedures
2.3.S.4.4 Batch analyses
2.3.S.4.5 Justification of specification
2.3.S.5 Reference standards or materials
2.3.S.6 Container closure system
2.3.S.7 Stability
2.3.S.7.1 Stability summary and conclusions
2.3.S.7.2 Post approval stability protocol and stability commitment
2.3.S.7.3 Stability data
2.3.P Drug product
2.3.P.1 Description and composition of the drug product
2.3.P.2 Pharmaceutical development
2.3.P.2.1 Components of the drug product
2.3.P.2.1.1 Drug Substance
2.3.P.2.1.2 Excipients
2.3.P.2.2 Drug product
2.3.P.2.2.1 Formulation Development
2.3.P.2.2.2 Overages
2.3.P.2.2.3 Physicochemical and biological properties
2.3.P.2.3 Manufacturing process development
2.3.P.2.4 Container closure system
2.3.P.2.5 Microbiological attributes
2.3.P.2.6 Compatibility
2.3.P.3 Manufacture
2.3.P.3.1 Manufacturers
2.3.P.3.2 Batch formula
2.3.P.3.3 Description of manufacturing process and process contro
2.3.P.3.4 Controls of critical steps and intermediates
2.3.P.3.5 Process validation and/or evaluation
2.3.P.4 Control of excipients
2.3.P.4.1 Specifications
2.3.P.4.2 Analytical procedures
2.3.P.4.3 Validation of analytical procedures
2.3.P.4.4 Justification of specifications
2.3.P.4.5 Excipients of human and animal origin
2.3.P.4.6 Novel excipients
2.3.P.5 Control of drug products
2.3.P.5.1 Specification(s)
2.3.P.5.2 Analytical procedures
2.3.P.5.3 Validation of analytical procedures
2.3.P.5.4 Batch analyses
2.3.P.5.5 Characterisation of impurities
2.3.P.5.6 Justification of specification(s)
2.3.P.6 Reference standards or materials
2.3.P.7 Container closure system
2.3.P.8 Stability
2.3.P.8.1 Stability summary and conclusions
2.3.P.8.2 Post approval stability protocol and stability commitment
2.3.P.8.3 Stability data
2.3.A APPENDICES
2.3.A.1 Facilities and equipment
2.3.A.2 Adventitious agents safety evaluation
2.3.A.3 Excipients
2.3.R REGIONAL INFORMATION
Pharmacology
Pharmacokinetics
Toxicology
2.7 Clinical Summary
Biopharmaceutics and Associated Analytical Methods
Clinical Pharmacology Studies
Clinical Efficacy
Clinical Safety
Synopses of Individual Studies
Module 3: Quality
3.1 TABLE OF CONTENTS
3.2 BODY OF DATA
3.2.S DRUG SUBSTANCE
(Drug substance manufacturer)
3.2.S.1 General information
3.2.S.1.1 Nomenclature
3.2.S.1.2 Structure
3.2.S.1.3 General properties
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturers
3.2.S.2.2 Description of manufacturing process and process controls
3.2.S.2.3 Control of materials
3.2.S.2.4 Controls of critical steps and intermediates
3.2.S.2.5 Process validation and/or evaluation
3.2.S.2.6 Manufacturing process development
3.2.S.3 Characterisation
3.2.S.3.1 Elucidation of structure and other characteristics
3.2.S.3.2 Impurities
3.2.S.4 Control of drug substance
3.2.S.4.1 Specification
3.2.S.4.2 Analytical procedures
3.2.S.4.3 Validation of analytical procedures
3.2.S.4.4 Batch analyses
3.2.S.4.5 Justification of specification
3.2.S.5 Reference standards or materials
3.2.S.6 Container closure system
3.2.S.7 Stability
3.2.S.7.1 Stability summary and conclusions
3.2.S.7.2 Post approval stability protocol and stability commitment
3.2.S.7.3 Stability data
3. 2.P DRUG PRODUCT
3.2.P.1 Description and composition of the drug product
3.2.P.2 Pharmaceutical development
3.2.P.2.1 Components of the drug product
3.2.P.2.1.1 Drug Substance
3.2.P.2.1.2 Excipients
3.2.P.2.2 Drug product
3.2.P.2.2.1 Formulation Development
3.2.P.2.2.2 Overages
3.2.P.2.2.3 Physicochemical and biological properties
3.2.P.2.3 Manufacturing process development
3.2.P.2.4 Container closure system
3.2.P.2.5 Microbiological attributes
3.2.P.2.6 Compatibility
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s)
3.2.P.3.2 Batch formula
3.2.P.3.3 Description of manufacturing process and process control
3.2.P.3.4 Controls of critical steps and intermediates
3.2.P.3.5 Process validation and/or evaluation.
3.2.P.4 Control of excipients
3.2.P.4.1 Specifications
3.2.P.4.2 Analytical procedures
3.2.P.4.3 Validation of analytical procedures
3.2.P.4.4 Justification of specifications
3.2.P.4.5 Excipients of human and animal origin
3.2.P.4.6 Novel excipients.
3.2.P.5 Control of drug products
3.2.P.5.1 Specification(s)
3.2.P.5.2 Analytical procedures
3.2.P.5.3 Validation of analytical procedures
3.2.P.5.4 Batch analyses.
3.2.P.5.5 Characterisation of impurities
3.2.P.5.6 Justification of specification(s).
3.2.P.6 Reference standards or materials
3.2.P.7 Container closure system
3.2.P.8 Stability
3.2.P.8.1 Stability summary and conclusions.
3.2.P.8.2 Post approval stability protocol and stability commitment.
3.2.P.8.3 Stability data.
3. 2.A APPENDICES
3.2.A.1 Facilities and equipment
3.2.A.2 Adventitious agents safety evaluation
3.2.A.3 Excipients
3. 2.R REGIONAL INFORMATION
3.2.R.1 Process validation scheme for the drug product
3.2.R.2 Medical device
3.2.R.3 Certificate of suitability
3.2.R.4 Medicinal products containing or using in the manufacturing process materials of animal and/ or human origin
3.3 LITERATURE REFERENCES
Module 4: Nonclinical Study Reports
4.2.1 Pharmacology
4.2.1.1 Primary Pharmacodynamics
4.2.1.2 Secondary Pharmacodynamics
4.2.1.3 Safety Pharmacology
4.2.1.4 Pharmacodynamic Drug Interactions
4.2.2 Pharmacokinetics
4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available)
4.2.2.2 Absorption 4.2.2.3 Distribution 4.2.2.4 Metabolism 4.2.2.5 Excretion
4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)
4.2.2.7 Other Pharmacokinetic Studies
4.2.3 Toxicology
4.2.3.1 Single-Dose Toxicity (in order by species, by route)
4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)
4.2.3.3 Genotoxicity 4.2.3.3.1 In vitro
4.2.3.3.2 In vivo (including supportive toxicokinetics evaluations)
4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations)
4.2.3.4.1 Long-term studies (in order by species; including rangefinding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)
4.2.3.4.2 Short- or medium-term studies (including range-finding studies that cannot appropriately be included under repeat dose toxicity or pharmacokinetics)
4.2.3.4.3 Other studies
4.2.3.5 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations) (If modified study designs are used, the following sub-headings should be modified accordingly.)
4.2.3.5.1 Fertility and early embryonic development
4.2.3.5.2 Embryo-fetal development 4.2.3.5.3 Prenatal and postnatal development, including maternal function
4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated.
4.2.3.6 Local Tolerance 4.2.3.7 Other Toxicity Studies (if available)
4.2.3.7.1 Antigenicity 4.2.3.7.2 Immunotoxicity 4.2.3.7.3 Mechanistic studies (if not included elsewhere)
4.2.3.7.4 Dependence 4.2.3.7.5 Metabolites 4.2.3.7.6 Impurities 4.2.3.7.7 Other
4.3 LITERATURE REFERENCES
Module 5: Clinical Study Reports
5.1 Table of Contents of Module 5
5.2 Tabular Listing of All Clinical Studies
5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutic Studies
5.3.1.1 Bioavailability (BA) Study Reports
5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports
5.3.1.3 In vitro-In vivo Correlation Study Reports
5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
5.3.2 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports
5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies
5.3.2.3 Reports of Studies Using Other Human Biomaterials
5.3.3 Reports of Human Pharmacokinetic (PK) Studies
5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports
5.3.3.2 Patient PK and Initial Tolerability Study Reports
5.3.3.3 Intrinsic Factor PK Study Reports
5.3.3.4 Extrinsic Factor PK Study Reports
5.3.3.5 Population PK Study Reports
5.3.4 Reports of Human Pharmacodynamic (PD) Studies
5.3.4.1 Healthy Subject PD and PK/PD Study Reports
5.3.4.2 Patient PD and PK/PD Study Reports
5.3.5 Reports of Efficacy and Safety Studies
5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
5.3.5.2 Study Reports of Uncontrolled Clinical Studies
5.3.5.3 Reports of Analyses of Data from More Than One Study
5.3.5.4 Other Clinical Study Reports
5.3.6 Reports of Post-Marketing Experience
5.3.7 Case Report Forms and Individual Patient Listings
5.4 Literature References
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WHO Section-2 |
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S.No |
API not described |
S.No |
API described |
S.No |
API MF format |
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2.1 |
Nomenclature |
2.1 |
Nomenclature |
2.1 |
Nomenclature |
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2.1.1 |
INN |
2.1.1 |
INN |
2.1.1 |
INN |
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2.1.2 |
Compendial name |
2.1.2 |
Compendial name |
2.1.2 |
Compendial name |
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2.1.3 |
Chemical name |
2.1.3 |
Chemical name |
2.1.3 |
Chemical name |
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2.1.4 |
Company code |
2.1.4 |
Company code |
2.1.4 |
Company code |
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2.1.5 |
Other INN |
2.1.5 |
Other INN |
2.1.5 |
Other INN |
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2.1.6 |
CAS Number |
2.1.6 |
CAS Number |
2.1.6 |
CAS Number |
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2.2 |
Properties of API (s) |
2.2 |
Properties of API (s) |
2.2 |
Properties of API (s) |
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2.2.1 |
API not described |
2.2.2 |
API described |
2.2.1/ 2.2.2 API not described/ API described |
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2.2.3 |
Information from literature |
2.2.3 |
Information from literature |
2.2.3 |
Information from literature |
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2.3 |
Site of manufacturing |
2.3 |
Site of manufacturing |
2.3 |
Site of manufacturing |
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2.4 |
Route of synthesis |
2.4 |
Route of synthesis |
2.4 |
Route of synthesis |
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2.4.1 |
API not described |
2.4.3 |
API described |
2.4.1/ 2.4.3 API not described /API described |
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2.4.1.1 |
2.4.3.1 |
Controls of Materials |
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2.4.1.2 |
2.4.3.2 |
Controls of critical steps & intermediates |
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2.4.1.3 |
2.4.3.3 |
Process Validation and Evaluations |
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2.4.1.4 |
2.4.3.4 |
Manufacturing process development |
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2.4.1.5 |
2.4.3.5 |
Characterization |
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2.4.1.6 |
2.4.3.6 |
Selected Physicochemical & |
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2.4.1.7 |
2.4.3.7 |
Impurities |
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2.4.2 |
Control of RM in synthesis |
2.4.2 |
Control of RM in synthesis |
2.4.2 |
Specifications of RM & Intermediates used in the synthesis |
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2.5 |
Specification |
2.5 |
Specification |
2.5 |
Specification |
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2.5.1 |
API not described |
2.5.2 |
API described |
2.5.1 |
2.5.2 |
API not described/ API described |
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2.5.1.1 |
2.5.2.1 |
Analytical procedures |
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2.5.1.2 |
2.5.2.2 |
Validation of Analytical procedures |
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2.5.1.3 |
2.5.2.3 |
Batch Analysis |
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2.5.1.4 |
2.5.2.4 |
Justification of specification |
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2.5.1.5 |
2.5.2.5 |
Ref. Stds. Or Materials |
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2.6 |
Container closure system |
2.6 |
Container closure system |
2.6 |
Container closure system |
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2.7 |
Stability testing |
2.7 |
Stability testing |
2.7 |
Stability |
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2.7.1 |
Stress testing(Fdegradation) |
2.7.1 |
Stress testing(Fdegradation) |
2.7.1.1 |
Stability summary and conclusion |
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2.7.2 |
Regulatory stability testing |
2.7.2 |
Regulatory stability testing |
2.7.2.1 |
Post Approval stability protocol and commitment |
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2.7.2.2 |
Stability data |
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Section-1 |
Section-4 |
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1.1 |
Details of the product |
4.1 |
Bioequivalence study report |
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1.1.1 |
Name, dosage form & strength of the product |
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1.1.2 |
Approved generic name(s) |
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1.1.3 |
Visual description of the FPP |
4.2 |
Summary of pharmacology, toxicology and efficacy of the product |
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1.1.4 |
Visual description of the Packaging |
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1.2 |
Samples |
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1.3 |
Registration status in other country |
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Section-3 |
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3.1 |
Manufacturing and marketing authorization |
3.10 |
C.C.S & other packaging |
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3.2 |
Pharmaceutical development |
3.11 |
Stability testing |
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3.2.1 |
Company R&D Formulation development Overages Physicochemical & Biological properties Manufacturing process development Container closure system Microbiological Attributes Compatibility |
3.11.1 |
Stability indicating parameters |
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3.11.2 |
Photo stability testing |
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3.11.3 |
Selection of batches |
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3.11.4 |
C.C.S |
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3.11.5 |
Testing frequency |
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3.11.6 |
Storage condition |
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3.11.7 |
General case |
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3.11.8 |
FPP’s packed in impermeable containers |
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3.2.2 |
Information from literature |
3.11.9 |
FPP’s packed in semi containers |
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3.3 |
Formulation |
3.11.10 |
Evaluation |
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3.4 |
Sites of Manufacture |
3.11.11 |
Extrapolation of data |
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3.5 |
Manufacturing process |
3.11.12 |
Core storage statement |
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3.6 |
Manufacturing process controls of critical steps and intermediates |
3.12 |
Container labeling |
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3.12.1 |
Outer packaging or where there is no outer packaging on the immediate packaging |
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3.7 |
Process Validation and/or Evaluation |
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3.7.1 |
New FPP’s |
3.12.2 |
Blisters & Strips |
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3.7.2 |
Established FPP’s |
3.13 |
Product information for health professional |
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3.8 |
Specifications for excipients |
3.14 |
Patient information and Package inserts |
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3.8.1 |
Excipients not described |
3.15 |
Justification for any differences to the product in the country or countries issuing the submitted WHO type certificate(s) |
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3.8.2 |
Excipients described |
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3.9 |
Control of the FPP |
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3.9.1 |
Specification for the FPP |
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3.9.2 |
Analytical procedures |
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3.9.3 |
Validation of Analytical procedures |
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3.9.4 |
Batch Analysis |
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Toc for europe, toc formate for dossier
