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Biovigilance Responsibilities of Sponsors of Biologicals  

Biologicals | Australia

Use this guide to determine if your change meets any of the following categories:

· corrects an ARTG entry
· creates a separate and distinct good
· is a safety-related variation
· has the potential to impact quality, safety, or efficacy

This article describes the following steps;

For a sponsor to determine if a change is a variation to an ARTG entry and how to apply for
approval, the following processes are involved:

1. Determine if the change would have been relevant to the inclusion decision
2. Determine if the change is a correction to your ARTG entry
3. Determine the variation category
4. Determine the supporting document requirements
5. Submit your application
6. Prepare and submit your cover letter and supporting documents
7. Pay your application fee
8. TGA screening of your application
9. Pay your evaluation fee
10. TGA evaluation of your supporting documents
11. Making a decision on your application
12. Implement the change(s) if approved

 

 

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Intended Use: Interpretation of Homologous Use  

Biologicals | Australia

Homologous use of the goods is the use of the goods to repair, reconstruct, replace or supplement
the cells or tissues of a person (the recipient), if the goods will perform the same basic function
or functions in the recipient as the original cells or tissues performed in the person from whom
they were collected (donor).

This article describes the following points;

  • Defining basic functions of human cells and tissues
  • Examples of homologous and non-homologous uses
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Autologous Human Cells and Tissues Products Regulation  

Biologicals | Australia

Human cell and tissue (HCT) products are those that comprise, contain, or are derived from human cells and tissues.

Autologous human cell and tissue (HCT) products are those that are removed from and applied to, the same person, i.e. the donor and the recipient are the same. One group of autologous HCT products is those commonly referred to as ‘stem cell treatments.

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Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa  

MedicinesBiologicalsHerbal Cosmetic Nutra | South Africa

Every applicant is required to report ADRs known to them involving their marketed medicines in accordance with the requirements of Act 101 of 1965 Regulation 40. The success of the Authority’s ADR reporting system depends on the quality, completeness, and accuracy of the information submitted. Reporting of ADRs and monitoring thereof, remain a viable means of identifying previously unrecognized, rare, or serious ADRs.

This guideline describes the following points;

  • Pharmacovigilance Obligations of The Holder Of A Certificate Of Registration/ Applicant
  • Adverse Drug Reaction Reports
  • Procedures for Reporting
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