GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE JANUARY 2009– GUIDELINE ON THE REGISTRATION OF HUMAN MEDICINAL PRODUCTS CONTAINING MATERIALS OF ANIMAL ORIGIN

ANNEX 1 CHECKLIST FOR THE REGISTRATION OF HUMAN MEDICINAL PRODUCTS CONTAINING MATERIALS OF ANIMAL ORIGIN

Appendix section

Document Yes/No (Encl. #)

For official

use

1.1 Products Containing Animal-Derived Materials WITH a valid TSE risk evaluation Certificate of Suitability (CEP)

1.1 (a) TSE Risk Evaluation Certificate of suitability (CEP)

Basic information providing a brief description of the following:

1.1 (b) (i) Rationale for using animal-derived materials

1.1 (b) (ii) Source of Animals

1.1 (b) (iii) Declaration of the nature of the animal tissue used.

1.1 (b) (iii) Description of the tissue/organ-collection procedures and measures in place to avoid cross-contamination.

1.1 (b) (iv) Nature and quantity of each animal-derived material used:

As a drug substance.

As an excipient or adjuvant.

As a starting material used in the manufacture of a drug substance/excipient.

As a reagent or culture media component used in manufacture.

As a reagent or culture media component used in establishing master/working cell banks.

Others, give details.

1.2 Products Containing Animal-Derived Materials WITHOUT a valid TSE risk evaluation Certificate of Suitability (CEP)

Detailed Assessment Report for the risk of TSE.

The scope of this assessment report should include the following:

1.1 (b) (i) Rationale for using animal-derived materials

1.1 (b) (ii) Source of Animals

1.1 (b) (iii) Declaration of the nature of the animal tissue used.

HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 1 of 2

GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE JANUARY 2009– GUIDELINE ON THE REGISTRATION OF HUMAN MEDICINAL PRODUCTS CONTAINING MATERIALS OF ANIMAL ORIGIN

Appendix section

Document Yes/No (Encl. #)

For official

use

1.1 (b) (iii) Description of the tissue/organ-collection procedures and measures in place to avoid cross-contamination.

1.2 (a) Details of the risk factors associated with the route of administration and maximum therapeutic dosage of the product.

1.1 (b) (iv) Nature and quantity of each animal-derived material used:

As a drug substance.

As an excipient or adjuvant.

As a starting material used in the manufacture of a drug substance/excipient.

As a reagent or culture media component used in manufacture.

As a reagent or culture media component used in establishing master/working cell banks.

Others, give details.

1.2 (a) (ii) Relevant information to support the claim that the manufacturing process is capable of inactivating TSE agents.

1.2 (b) Certificates of analysis for each animal-derived materials used

HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 2 of 2