Submissions received and TGA response: Business process improvements supporting complementary medicines assessment pathways

25 January 2018

The TGA would like to thank respondents who provided submissions in response to the September 2017 public consultation paper Consultation: Business process improvements supporting complementary medicines assessment pathways.

A total of 14 submissions were received, which comprised:

  • 7 submissions from industry and peak industry bodies
  • 6 submissions from consumer, healthcare and other professional bodies
  • 1 submission from a regulatory affairs consultant

All submissions that gave permission to be published on the TGA website are available below in PDF format.

Submissions

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TGA response

Submissions received in response to the consultation showed that the majority of stakeholders generally supported the proposed approach to implement these reforms. Stakeholders were particularly supportive of the risk based application categories. Views were mixed regarding opportunities for applicants to supply information during the evaluation period that meets the criteria for use of evaluation reports from comparable overseas regulators and alternative sources of evidence and the new fee proposal.

Stakeholder feedback has informed our position going forward including upcoming changes to the Therapeutic Goods Regulations 1990. We will continue to seek the feedback of relevant stakeholders to help us refine our approach and address any concerns raised during the implementation phase.

Changes resulting from the feedback are summarised in the Outcome Summary below noting further targeted feedback will be sought in some cases.

Further information on implementation arrangements and guidance documentation for reforms in this consultation will be included on the TGA website in the coming months.

Outcome summary

Summary of changes resulting from public consultation: Business process improvements supporting complementary medicines assessment pathways

Table 1: Risk based application categories for complementary medicines and ingredients
Current situation Proposed change Benefits

Currently there is one application category for pre-market assessment for new ingredients.

There are a range of application categories for registered complementary medicines, however these have not been formalised.

There are no application categories for the assessed listed medicines pathway (as this new pathway has not yet been introduced).

A set of risk-based application categories will be introduced within each of the complementary medicines pre-market assessment processes:

  • New ingredients for use in listed medicines (IN1 - IN4)
  • Assessed listed medicines (L(A)1 - L(A)3)
  • Registered complementary medicines (RCM1 - RCM5)

The categories will differ in the amount and type of information we will need to review, the level of scrutiny the application receives and the assessment timeframe. The application categories allow for a combination of de novo assessment and use of reports from comparable overseas regulators (CORs).

Provides an appropriate risk-based model for the evaluation of complementary medicines.
Table 2: Use of reports from comparable overseas regulators
Current situation Proposed change Benefits
Applicants are unable to provide reports from comparable overseas regulators as the primary source of evidence for assessment of new complementary medicines or ingredients.

There will be a framework for the identification and use of evaluation reports from comparable overseas regulators.

Once an overseas regulator has been assessed as both comparable and their assessments appropriate, they will be included as a comparable overseas regulator in a list published on the TGA website.

These reports can then be submitted with any additional Australian-specific data. For applicants submitting an acceptable report from a comparable overseas regulator the evaluation will be streamlined and timeframes will be reduced.

Changes will facilitate medicines coming to market more quickly in Australia and reduce burden for industry.

Reduced duplication of regulatory effort.

Improved flexibility for applicants about the types of information that can be used to support pre-market applications.

Table 3: Alternative evidence sources for assessment of higher risk complementary medicines and ingredients
Current situation Proposed change Benefits
The current range of evidence that is accepted for evaluation of new complementary medicine ingredients is limited and has not been formalised.

There will be a framework for the identification and use of alternative sources of evidence that can be used to support applications for new ingredients.

A list of acceptable sources of evidence will be published on the TGA website for use by applicants.

The range of acceptable evidence sources for ingredient assessments will be broadened.

Improves the efficiency of complementary medicines evaluations.

Provides industry with greater certainty and clarity about evidence requirements.

Table 4: Legislated assessment timeframes
Current situation Proposed change Benefits
There are no prescribed timeframes for assessing applications for registered complementary medicine or new ingredients assessed for use in listed complementary medicines.

Legislated timeframes for complementary medicines pre-market assessment pathways will be introduced for:

  • New ingredients for use in listed medicines
  • Assessed listed medicines
  • Registered complementary medicines

Timeframes align with the risk-based application categories (see above).

All applications that involve pre-market assessment will follow similar assessment processes, with lower application levels having shorter assessment timeframes due to the reduction in information to be evaluated.

TGA intends to move to a single consolidated request for information at a future time - once the new business processes are well established.

Legislated timeframes will improve predictability for industry, thereby allowing sponsors to better plan the roll out of new products to the market.

A standardised submission process will help ensure that legislated timeframes can be met and improve the quality of complementary medicine applications.

Provides consumers with more timely access to high quality, safe and effective complementary medicines

Table 5: New fee structure to support the risk based application categories
Current situation Proposed change Benefits
Applicants seeking evaluation of new ingredients and registered complementary medicines are currently required to self-determine the appropriate evaluation fee based on the total page count. A new fee structure will be introduced that corresponds to the application categories (see above) and reflects the amount of work required to assess each type of application and ensure best practice cost recovery. For example, the fees for an RCM 1 application will be commensurately lower than those for a more complex RCM 5 application.

The introduction of a new fee structure based on work effort will complement the business improvements and proposed legislated timeframes and ensure they are aligned with the costs of providing evaluation services.

Improves the quality of complementary medicine applications.