Data Requirements for Veterinary Products - SFDA · Data Requirements for Veterinary Products ... 6288, Saudi Arabia . Page 2 of 13 [Data Requirements for Veterinary ... Proce s validation

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Data Requirements for Veterinary Products

Version 1.0

This draft is for comments;

please review and send your comments or suggestions to SFDA

E-Mail: [email protected], Fax No. 0096612057635

3292 North Highway Al Nafal Unit (1) - Riyadh 13312 – 6288, Saudi Arabia

mailto:[email protected]

Page 2 of 13

[Data Requirements for Veterinary

Products ]

Version 1.0

Drug Sector

Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug

for the latest update

http://www.sfda.gov.sa/En/Drug

http://www.sfda.gov.sa/En/Drug

Page 3 of 13

Content:

Data Requirements for Veterinary Pharmaceutical Products……………………..………4

Data Requirements for Veterinary Immunological Products……………………………..8

Data Requirements for Veterinary Insecticides……………………………….…………11

Page 4 of 13

Data Requirements for Veterinary Pharmaceutical Products

Section Requirements Generic New

Module 1

Regional Administrative Information

1. Cover letter R R

1.1. Comprehensive table of content R R

1.2. Application Form R R

1.3. Product Information

1.3.1. Summary of Product Characteristics (SPC) R R

1.3.2. Labeling R R

1.3.3. Package leaflet

1.3.3.1. Arabic leaflet R R

1.3.3.2. English leaflet R R

1.3.4. Artwork (Mock-ups) R R

1.3.5. Samples R R

1.4. Information on the experts

1.4.1. Quality R R

1.4.2. Safety and Residues O R

1.4.3. Efficacy O R

1.5. Pharmacovigilance

1.5.1. Pharmacovigilance System O O

1.5.2. Risk Management Plan O O

1.6. Certificates

1.6.1. CPP or Free-sales R R

1.6.2. Certificate of analysis – Drug Substance R R

1.6.3. Certificate of analysis – Excipients R R

1.6.4. Certificate of analysis – Finished Product R R

1.6.5. Alcohol-free declaration O O

1.6.6. Pork-free declaration R R

1.6.7. The diluents and coloring agents in the product formula R R

1.6.8. Patent Information R R

1.7. Pricing

1.7.1. Price list O O

1.7.2. Other related documents O O

1.8. Responses to questions R R

Module 2

Common Technical Document Summaries

2.1. Table of Contents of Module 2-5 R R

2.2. Quality Overall Summary

2.2.1. Composition of the Product R R

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2.2.2. Description of the Manufacturing Method R R

2.2.3. Control of Starting Materials

2.2.3.1. Active substance(s) R R

2.2.3.2. Excipient(s) R R

2.2.3.3. Container/Closure System R R

2.2.3.4. Substances of Biological Origin R R

2.2.4. Control Tests on Intermediate Products (if necessary) R R

2.2.5. Control Tests on the Finished Product R R

2.2.6. Stability R R

2.3. Safety and Residues Tests Overall Summary

2.3.1. Safety documentation O R

2.3.2. Residue documentation O R

2.4. Efficacy Overall Summary

2.4.1. Pre-clinical Documentation

2.4.1.1. Pharmacodynamics O R

2.4.1.2. Pharmacokinetics O R

2.4.1.3. Target species tolerance O R

2.4.1.4. Resistance O R

2.4.2. Clinical documentation O R

Module 3

Quality

3.1. Table of Contents of Module 3 R R

3.2. Composition

3.2.1. Composition of the veterinary medicinal product R R

3.2.2. Container/Closure System R R

3.2.3. Pharmaceutical Development O R

3.3. Description of the Manufacturing Method

3.3.1. Manufacturing formula R R

3.3.2. Manufacturing process R R

3.3.3. Process validation R R

3.4. Control of Starting Materials

3.4.1. Active substance(s)

3.4.1.1. Specification R R

3.4.1.2. Justification of Specification R R

3.4.1.3. Scientific Data

3.4.1.3.1. Nomenclature R R

3.4.1.3.2. Description R R

3.4.1.3.3. Manufacture R R

3.4.1.3.4. Quality control during manufacture R R

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3.4.1.3.5. Development chemistry R R

3.4.1.3.6. Impurities R R

3.4.1.3.7. Batch analysis R R

3.4.2. Excipient(s)

3.4.2.1. Specifications R R

3.4.2.2. Justification of Specification R R

3.4.2.3. Scientific data R R

3.4.3. Container/Closure System R R

3.4.4. Substances of Biological Origin R R

3.5. Control Tests on Intermediate Products R R

3.6. Control Tests on the Finished Product

3.6.1. Product Specifications R R

3.6.2. Justification of Specifications R R

3.6.3. Control Methods

3.6.3.1.

Test procedures for identification and

quantitative determination for the active

substance(s).

R R

3.6.3.2. Identification and determination of excipient(s) R R

3.6.4. Scientific data

3.6.4.1. Validation of Analytical Procedures R R

3.6.4.2. Batch analyses R R

3.7. Stability

3.7.1. Stability tests on active substance(s) R R

3.7.2. Stability tests on the finished product R R

3.8. Other Related Documents R R

3.9. Literature References R R

Module 4

Safety and Residues Tests


4.2. Safety documentation

4.2.1. Precise identification of the product concerned by the

application

O R

4.2.2. Pharmacological studies

4.2.2.1. Pharmacodynamics O R


4.2.3. Toxicological studies O R

4.2.4. Studies of other effects O R

4.2.5. User safety O R

4.2.6. Environmental risk assessment O R

4.3. Residue documentation

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4.3.1. Precise identification of the product concerned by the

application

O R

4.3.2. Residue Studies


4.3.2.2. Depletion of residues O R

4.3.2.3. Maximum Residue Limits (MRL) O R

4.3.2.4. Withdrawal periods R R

4.3.3. Analytical Method(s)

4.3.3.1. Description of the method O R

4.3.3.2. Validation of the method O R

4.4. Other Related Documents O R


Module 5

Efficacy


5.2. Pre-clinical Documentation

5.2.1. Pharmacodynamics O R

5.2.2. Pharmacokinetics O R

5.2.3. Target species tolerance O R

5.2.4. Resistance O R

5.3. Clinical documentation O R

5.4. Other Related Documents O R


Page 8 of 13

Data Requirements for Veterinary Immunological Products

Section Requirements

Module 1

Regional Administrative Information

1. Cover letter R

1.1. Comprehensive table of content R

1.2. Application Form R


1.3.1. Summary of Product Characteristics (SPC) R

1.3.2. Labeling R


1.3.3.1. Arabic leaflet R

1.3.3.2. English leaflet R

1.3.4. Artwork (Mock-ups) R

1.3.5. Samples R

1.4. Information on the experts

1.4.1. Quality R

1.4.2. Non-Clinical R

1.4.3. Clinical R

1.5. Pharmacovigilance

1.5.1. Pharmacovigilance System O

1.5.2. Risk Management Plan O

1.6. Certificates

1.6.1. CPP or Free-sales R

1.6.2. Certificate of analysis – Drug Substance R

1.6.3. Certificate of analysis – Excipients R

1.6.4. Certificate of analysis – Finished Product R

1.6.5. Alcohol-free declaration O

1.6.6. Pork-free declaration R

1.6.7. The diluents and coloring agents in the product formula R

1.6.8. Patent Information R

1.7. Pricing

1.7.1. Price list O

1.7.2. Other Related Documents O

1.8. Responses to questions R

Module 2

Common Technical Document Summaries

2.1. Table of Contents of Module 2-5 R


2.2.1. Composition of the Product R

Page 9 of 13

2.2.2. Production and Control of Starting Materials R

2.2.3. Control Tests During Production R

2.2.4. Control Tests on the Finished Product R

2.2.5. Batch to Batch Consistency R

2.2.6. Stability Tests R

2.2.7. Substances of Biological Origin R

2.3. Safety Overall Summary

2.3.1. Laboratory Tests R

2.3.2. Field Studies R

2.3.3. Environmental Risk Assessment R


2.4.1. Laboratory Trials R

2.4.2. Field Trials R

Module 3

Quality

3.1. Table of Contents of Module 3 R

3.2. Composition

3.2.1. Composition of the veterinary immunological product R

3.2.2. Container/Closure System R

3.2.3. Pharmaceutical Development R

3.3. Description of the Manufacturing Method

3.3.1. Manufacturing process R

3.3.2. Process validation R

3.4. Production and Control of Starting Materials R

3.5. Control Tests During Production R

3.6. Control Tests on the Finished Product

3.6.1. General characteristics of the finished product R

3.6.2. Identification of active substance(s) R

3.6.3. Batch titre or potency R

3.6.4. Identification and assay of adjuvants R

3.6.5. Identification and assay of excipient components R

3.6.6. Safety tests R

3.6.7. Sterility and purity test R

3.6.8. Residual humidity R

3.6.9. Inactivation R

3.7. Batch to Batch Consistency R

3.8. Stability Tests R

3.9. Substances of Biological Origin R

3.10. Other Related Documents R

Page 10 of 13

3.11. Literature References R

Module 4

Safety


4.2. Laboratory Tests

4.2.1. Safety of the administration of one dose R

4.2.2. Safety of one administration of an overdose R

4.2.3. Safety of the repeated administration of one dose R

4.2.4. Examination of reproductive performance R

4.2.5. Examination of immunological functions R

4.2.6. Special requirements for live vaccines R

4.2.7. User safety R

4.2.8. Study of residues R

4.2.9. Interactions R

4.3. Field Studies R

4.4. Environmental Risk Assessment R



Module 5

Efficacy


5.2. Laboratory Trials

5.3. Field Trials R



Page 11 of 13

Data Requirements for Veterinary Insecticides

Section Requirements

Module 1 Regional Administrative Information

1. Cover letter R

1.1. Comprehensive table of content R

1.2. Application Form R


1.3.1. Labeling R


1.3.2.1. Arabic leaflet R

1.3.2.2. English leaflet R

1.3.3. Artwork (Mock-ups) R

1.3.4. Samples R

1.4. Certificates

1.4.1. CPP or Free-sales R

1.4.2. Certificate of analysis – Active Constituents O

1.4.3. Certificate of analysis – Inactive Constituents O

1.4.4. Certificate of analysis – Finished product R

1.4.5. Patent Information O

1.5. Pricing

1.5.1. Price list O

1.5.2. Other related documents O

1.6. Responses to questions R

Module 2 Common Technical Document Summaries

2.1. Table of Contents of Module 2-5 R


2.2.1. Description and quantitative composition of the product R

2.2.2. Control of Starting Materials

2.2.2.1. Specifications R

2.2.2.2. Analytical Procedures R

2.2.2.3. Validation of Analytical Procedures R

2.2.2.4. Batch Analyses R

2.2.3. Finished Product

2.2.3.1. Specifications R

2.2.3.2. Analytical Procedures R

2.2.3.3. Validation of Analytical Procedures R

2.2.3.4. Batch Analyses R

2.2.3.5. Manufacture of the Finished Product R

2.2.3.6. Container Closure System of the Finished Product R

2.2.3.7. Stability of the Finished Product R

Page 12 of 13

2.3. Safety and Residues Tests Overall Summary

2.3.1. Safety Tests

2.3.1.1. Toxicology. R

2.3.1.2. User Risk Assessment (URA). R

2.3.1.3. Environmental Risk Assessment (ERA). R

2.3.2. Residue Tests

2.3.2.1. Identification of product. R

2.3.2.2. Metabolism and residue kinetics. R

2.3.2.3. Residue analytical method. R

2.3.2.4. Maximum residue limits (MRLs), and

withholding periods.

R


2.4.1. Efficacy Studies R

2.4.2. Reports of Post-Marketing Experience R

Module 3 Quality


3.2. General Information

3.2.1. Name of the product R

3.2.2. Description and quantitative composition of the product R

3.3. Control of Starting Materials

3.3.1. Specifications R

3.3.2. Analytical Procedures O

3.3.3. Validation of Analytical Procedures O

3.3.4. Batch Analyses R

3.4. Finished Product

3.4.1. Specifications R

3.4.2. Analytical Procedures R

3.4.3. Validation of Analytical Procedures R

3.4.4. Batch Analyses R

3.4.5. Manufacture of the Finished Product

3.4.5.1. Manufacturer(s) R

3.4.5.2. Description of Manufacturing Process and In

Process Controls

R

3.4.5.3. Batch Formula R

3.4.5.4. Controls of Critical Steps and Intermediates R

3.4.5.5. Process Validation and/or Evaluation R

3.4.6. Container Closure System of the Finished Product R

3.4.7. Stability of the Finished Product

3.4.7.1. Stability Summary and Conclusions R

3.4.7.2. Stability Data R



Page 13 of 13

Module 4 Safety and Residues Tests


4.2. Safety Tests

4.2.1. Toxicology. R

4.2.2. User Risk Assessment (URA). R

4.2.3. Environmental Risk Assessment (ERA). R

4.3. Residue Tests

4.3.1. Identification of product. R

4.3.2. Metabolism and residue kinetics. R

4.3.3. Residue analytical method. R

4.3.4. Maximum residue limits (MRLs), and withholding

periods.

R



Module 5 Efficacy


5.2. Efficacy Studies R

5.3. Reports of Post-Marketing Experience R

