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INDONESIA |
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Authority |
NA-DFC: the national agency of drug & food control |
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website |
www.pom.go.id/nonpublic/obat/e_default.asp |
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if any |
www.depkes.go.id/ |
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REQUIREMENT FOR PRODUCT REGISTRATION |
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S.No |
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INDEX |
Page. No |
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PART - I Administrative data and product information |
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Section A |
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A1 |
Name of the product |
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A2. |
Name and Strength of active ingredients |
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A3. |
Product Description |
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A4.1 Pharmacodynamics |
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A4.2 Pharmacokinetics |
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A5 |
Indications |
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A6 |
Recommended dose |
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A7 |
Mode of administration |
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A8 |
Contraindication |
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A9 |
Warnings and precautions |
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A10 |
Interaction with other medicaments |
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A11 |
Pregnancy and lactation |
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A12 |
Side effects 7 - 7 8 - 8 |
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A13 |
Symptoms and treatment of overdose |
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A14 |
Storage conditions |
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A15 |
Shelf life |
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A16 |
Therapeutic code |
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Section B: |
Product formula |
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B1.1 |
Batch manufacturing formula |
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B1.2 |
Attachment of batch formula documentation |
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Section C: |
Particulars of packing |
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C1 |
Pack size |
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C2 |
Immediate container type |
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C3 |
Barcode/Serial No. |
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C4 |
Recommended distributor price |
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C5 |
Recommended retail price |
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Section D : |
Label (Mockup) for intermediate container, outer carton and proposed package insert |
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D1 |
Label (Mockup) for intermediate container |
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D2 |
Label (Mockup) for outer carton |
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D3 |
Proposed package insert |
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Section E: |
Supplementary documentation |
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E1.1 |
Product owner |
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E1.2 |
Letter of authorization from product owner |
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E2.1 |
Letter of appointment of contract manufacturer |
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E2.2 |
Letter of acceptance of contract manufacturer |
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E3 |
Is the active substance patented in Malaysia |
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E4 |
Certificate of pharmaceutical product (CPP) |
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E5 |
Certificate of free sale (CFS) |
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E6 |
Certificate of good manufacturing practice (GMP) |
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E7 |
Summary of product characteristics (product data sheet) |
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E8 |
Patient information leaflet (PIL) |
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E9 |
Attachment of protocol analysis |
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E10 |
Attachment of analysis validations |
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E11 |
Attachement of certificate of analysis |
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E12 |
Other supporting documentation |
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E13 |
Manufacturer |
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E13.1 |
Importer |
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E14 |
Other manufacturer involved (if any) |
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E15 |
Storage address (if any) |
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PART – II : Quality |
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P: DRUG PRODUCT |
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P1 |
Description and Composition of the Drug Product |
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P2 |
Pharmaceutical Development |
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P2.1 |
Information on Development Studies |
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P 2.2 |
Components of the Drug Product |
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P 2. 3 |
Finished Product |
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P 2.4 |
Manufacturing Process Development |
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P2.5 |
Container Closure System |
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P2.6 |
Microbiological Attributes |
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P3 |
Manufacture |
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P3.1 |
Batch Formula |
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P3.2 |
Manufacturing Process And Process Controls |
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P3.2.1 Manufacturing process flowchart |
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P3.3 |
Control of Critical steps and intermediates |
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P3.4 |
Process validation and/or evaluation |
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P4 |
Control of Excipients |
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P4.1 |
Specifications |
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P4.2 |
Analytical procedures |
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P4.3 |
Validations of analytical procedure |
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P4.4 |
Justification of specifications |
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P4.5 |
Excipients of human and animal origin |
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P4.6 |
Novel Excipients |
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P5 |
Control of Drug Product (Finished Product) |
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P5.1 |
Specification |
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P5.2 |
Analytical Procedures |
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P5.3 |
Validation of Analytical Procedures (for non compendial method) |
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P5.4 |
Batch Analyses |
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P5.5 |
Characteristics of Impurities |
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P5.6 |
Justification of Specifications |
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P6 |
Reference Standards or Materials |
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P7 |
Container Closure System |
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P8 |
Stability |
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P9 |
Product Interchangeability/BE study. |
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S. Drug Substance (Active substance) |
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S1. |
General Information |
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S1.1 |
Nomenclature |
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S1.2 |
Structure |
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S1.3 |
General Properties |
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S2 |
Manufacture |
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S2.1 |
Manufacturer(s): Name and address |
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S2.2 |
Description of manufacturing process and process control |
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S2.3 |
Control of material |
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S2.4 |
Control of Critical steps and intermediates |
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S2.5 |
Process validation and/or evaluation |
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S2.6 |
Manufacturing process and development |
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S3 |
Characterization |
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S3.1 |
Elucidation of Structure and other Characteristics |
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S3.2 |
Impurities |
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S4 |
Control of Drug Substance |
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S4.1 |
Specification of Drug Substance |
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S4.2 |
Analytical Procedures |
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S4.3 |
Validation of Analytical Procedures |
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S4.4 |
Batch Analyses |
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S4.5 |
Justification of Specification |
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S5 |
Reference Standards or Materials |
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S6 |
Container Closure System |
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S7 |
Stability |
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PART III: Non clinical data |
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IIIA: |
Table of contents |
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IIIB: |
Non clinical over view |
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1. |
Over view of non clinical testing strategy (Product development rationa |
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2. |
Pharmacology |
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3. |
Pharmacokinetics |
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4. |
Toxicology |
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5. |
Integrated overview and conclusion |
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6. |
Literature reference |
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7. |
Information about non – clinical expert |
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IIIC: |
Non clinical summary |
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C1 |
Non clinical Written summary |
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C1.1 Pharmacology |
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C1.2 Pharmacokinetics |
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C1.3 Toxicology |
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IIID: |
Non clinical study report |
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PART IV: Clinical data |
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IVA: |
Table of content |
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IVB: |
Clinical over view |
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1. |
Product development rational |
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2. |
Overview of biopharmaceutics |
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3. |
Overview of clinical pharmacology |
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4. |
Overview of efficacy |
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5. |
Overview of safety |
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6. |
Benefits and risks conclusions |
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7. |
Literature reference |
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8. |
Information about clinical expert |
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IVC |
Clinical summary |
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IVD |
Tabulated list of all clinical studies |
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IVE |
Clinical study report |
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Toc for indonesia, toc formate for product registration
