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Purpose
This guidance is for prospective sponsors who:
- are preparing an application to register a medicine for oral ingestion
- wish to seek the TGA's advice on a biowaiver justification
- can provide data in support of the biowaiver justification as an eCTD submission.
This guidance outlines how to request early scientific advice on data to support certain biowaiver justifications, which may assist in preparing a scientifically sound dossier to support an application for medicine registration.
This process is optional and independent from the process for applying for registration. The two processes serve different purposes:
- The early scientific advice process assesses the scientific merits of data generated in respect to a certain aspect of a new medicine. Scientific advice from the TGA can form part of an application for registration but does not provide any indication on whether the application for registration will be successful.
- The evaluation of an application for registration is to determine if the quality, safety and efficacy of the medicine have all been satisfactorily established. Approval to register is only given if the benefits outweigh the risks; this decision is based on the total evidence.
Early scientific advice from TGA is not legally binding on the TGA or on the medicine developer. However, if a subsequent application for registration is submitted, the delegate within the TGA must have regard to the advice when making the decision to approve the application.
Biowaiver justifications eligible for scientific advice
You can request TGA advice on the following types of justifications:
- Biopharmaceutic Classification System (BCS)-based biowaiver justification
- Additional strength biowaiver justification
- Justification for use of an overseas reference product in a bioequivalence study.
How to submit a request for scientific advice
To request scientific advice:
- Pay the prescribed fee:
- Pay online with a credit card (preferred) at the online payment site: select Early Scientific Advice in the drop down menu.
- Other payment options are available at Payment options, please note though, making payment other than online may delay the process.
- Complete the Request for early scientific advice form and include your payment receipt number to Section 3 of the form.
- Submit the completed form and data as an eCTD sequence to the eSubmissions team via:
- email (eSubmissions@health.gov.au cc: accountsrec@health.gov.au) or
- physical media (you will need to separately email a copy of the completed request form to accountsrec@health.gov.au).
| Current regional specifications (v3.1) | |
|---|---|
| Sequence Type | Undefined Regulatory Activity |
| Sequence Description | Uncategorised {Early Advice} |
| Regulatory Activity Lead | Any |
| Submission number | Use the therapeutic area prefix (e.g. PM) followed by the payment receipt number |
| Advice request form | Include as a flattened (1 layer) pdf in m.1.2.1 |
Data to be submitted
Submit data to support the justification. The data must be consistent with:
- Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **)
- Guideline on the pharmacokinetic and clinical evaluation of modified release oral and transdermal dosage forms (CPMP/EWP/280/96 Corr).
- Guidance on Biopharmaceutic studies (sections 15.6 and 15.9).
Not all data may be available at the time a request is sought. Our advice will be based on what data was submitted with the request. We will not seek additional data or clarification on the information submitted prior to providing advice on the acceptability of the justification.
Assessing your justification
We will assess the justifications to determine whether a biowaiver is appropriate. The target timeframe for providing advice is 45 working days.
Our review will be limited to module 1.9 of the dossier. In some instances, additional information may be relevant to the biowaiver justification, for example, development of the dissolution method. If this information is not included in module 1.9 of the dossier, the advice will be conditional on these aspects being acceptable.
Once we have competed our assessment, we will inform you via email either that:
- the data appropriately supports the proposed biowaiver justification, or
- you have not justified use of a biowaiver (we will provide an explanation why it is not justified).
Subsequent actions
After receiving our advice, you can choose to submit an application for registration of the medicine:
- that includes the same data as was provided in the request for early scientific advice or
- with new or additional data.
If you submit a subsequent registration application, include the advice received from the TGA in Module 1 in your dossier. As part of the market authorisation decision the TGA delegate is required to consider any early advice previously provided in relation to that medicine.
Legislative basis
Section 22G of the Therapeutic Goods Act 1989 enables the Secretary to provide scientific advice about a prescribed safety, quality or efficacy aspect of a registrable medicine.
Regulation 10M of the Therapeutic Goods Regulations 1990 defines the aspects to which the request may apply.
Item 1ABA in Schedule 9 of the Regulations identifies the fee that applies to these requests.