Lebanon Drug Product Registration

Labelling and Prescribing Information

A biosimilar label would include a statement that the product is a biosimilar to a reference, give the name of the reference product and would provide a brief definition of what it means to be biosimilar in a footnote.

List of Requirements for the registration of Biosimilar products according to CTD format

Module 1: Administrative Information

1.1 Cover letter/application form/proposed summary of product characteristics/labelling and package insert leaflet.

1.2 Trade name

1.3 Generic name

1.4 Expiry date

1.5 Other trade names of the similar product

1.6 Pharmaceutical form

1.7 Name of manufacturing company

1.8 Name of active substance manufacturer (if different from above)

1.9 Agent in Lebanon

Name and Address

1.10 Marketing status at country of origin and other countries

1.11 Reference medicinal product (RMP) – The innovator Name, Approval at EMA/FDA

1.12: Labelling product information

Module 2: Common technical document summaries

2.1. Table of contents of Modules 2 – 5.

2.2. Introduction.

2.3. Quality overall summary.

2.4. Pre-clinical overview:

2.5. Clinical overview.

2.6. Pre-clinical summary.

2.6.1. Pharmacology written summary.

2.6.2. Pharmacology tabulated summary.

2.6.3. Pharmacokinetics written summary.

2.6.4. Pharmacokinetics tabulated summary.

2.6.5. Toxicology written summary.

2.6.6. Toxicology tabulated summary.

2.7. Clinical summary

2.7.1. Summary of biopharmaceutical studies and associated analytical methods.

2.7.2. Summary of clinical pharmacology studies.

2.7.3. Summary of clinical efficacy.

2.7.4. Summary of clinical safety.

2.7.5. Literature references.

2.7.6 Synopses of individual studies.

Module 3: Quality

3.2.S. Active substance(s).

3.2.S.1. General information

3.2.S.1.2. Structure

3.2.S.1.3. General properties

3.2.S.2. Manufacture of active substance(-s):

3.2.S.2.1. Manufacturer(s).

3.2.S.2.2. Description of manufacturing process and process controls.

S.2.S.2.3. Control of materials

3.2.S.2.4. Controls of critical steps and intermediates.

3.2.S.2.4.1 Critical steps

3.2.S.2.4.2 Intermediates

3.2.S.2.5. Process validation and/or evaluation.

3.2.S.2.6. Manufacturing process development.

3.2.S.3. Characterization of active substance(-s).

3.2.S.3.1. Elucidation of structure and other characteristics.

3.2.S.3.2. Impurities.

3.2.S.4. Control of active substance(s).

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. Finished medicinal product

3.2.P.1. Description and composition of the finished medicinal product

3.2.P.2. Pharmaceutical development

3.2.P.2.1. Composition of the finished medicinal product

3.2.P.2.1.1. Active substance(s).

3.2.P.2.1.2. Excipients.

3.2.P.2.2. Medicinal 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.

3.2.3 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 of the finished medicinal product

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 controls.

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 or animal origin.

3.2.P.4.6. Novel excipients.

3.2.P.5. Control of finished medicinal product

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. Characterization of impurities.

3.2.P.5.6. Justification of specification(s).

3.2.P.6. Reference standards and materials.

3.2.P.7.Container closure system.

 3.2.P.8. Stability

3.2.P.8.1. Stability summary and conclusion

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.2.1 For non-viral adventitious agents

3.2.A.2.2 For viral adventitious agents

3.3. Literature references.