Proposed GMP exemption for certain bacteriophage manufacture

Overview

The purpose of this consultation is to seek feedback on potential changes to the Therapeutic Goods Regulations 1990 applying to manufacturing of certain bacteriophage therapy products (BTPs) in Australia.

Bacteriophages can present a potentially life-saving therapeutic option in the treatment of multidrug-resistant infections. However, it is still considered an experimental therapy and there are no TGA approved BTPs and no Good Manufacturing Practice (GMP) licensed facilities in Australia.

To support the sector to continue to develop, the TGA proposes to introduce a temporary exemption from GMP requirements (i.e. from the operation of Part 3-3 of the Act and the requirement to hold a TGA manufacturing licence) for manufacturers of personalised and small batch BTPs.

This is intended to ensure that continued access for patients via Special Access Scheme (SAS), Authorised Prescriber (AP) and clinical trial pathways is not impacted, and to provide time for such manufacturers to apply for and obtain a manufacturing licence under the Act. An exemption from GMP licensing would also allow the sector to continue to refine manufacture and collect supportive clinical data, similar to the exemption for products manufactured for early phase clinical trials.

The TGA wants to ensure regulation of BTPs remains fit-for-purpose and considers patients’ need to access as well as quality and safety of treatments administered.

Why your views matter

Feedback obtained from this consultation will inform amendments to the Regulations and affect the manufacturing of personalised bacteriophage therapies in Australia.

How to respond

1. Read the Consultation paper on the proposed amendment (see link below).

2. Go to the online consultation questions by clicking on 'Online survey' below.

3. The questions marked as ‘Required’, are mandatory - they must be completed in order to move to next page in the survey. Insert 'not applicable' or 'n/a' if the question does not apply to you.

4. If you wish to provide further information, please do so in the free text box provided below the question OR upload a PDF submission at end of the consultation. 

5. If you have difficulty making your submission, contact  TGA.Scientific@health.gov.au and include ‘Bacteriophage consultation ' in the subject line of the email.

Consultation paper

Consultation on including a time-limited GMP exemption for manufacturing of personalised bacteriophages