Changes to evaluation of substances for use in listed complementary medicines

3 May 2018

The process for evaluation of substances for use in listed complementary medicines has changed.

The TGA has introduced new application categories and legislated timeframes for evaluation of substances for use in listed complementary medicines. These changes are intended to:

  • provide greater transparency and predictability for applicants
  • improve flexibility for applicants about the types of information that can be used to support an application

There is also a new mechanism to permit a successful applicant of a new complementary medicine substance to have exclusive use of that ingredient for a specified period of time. Implementation of this reform aims to support innovation and improve the evidence base for complementary medicines.

The introduction of these changes is part of the implementation the Government's reforms to the regulatory framework for complementary medicines arising from the Medicines and Medical Devices Regulation Review (MMDR).

Background

Listed complementary medicines may only contain ingredients included in the Therapeutic Goods (Permissible Ingredients) Determination (the Permissible Ingredients Determination).

For a substance to be permitted for use as an ingredient in listed complementary medicines, an applicant must submit an Application for evaluation of a substance for use in listed complementary medicines. The TGA will evaluate the substance to determine whether it is of appropriate quality and safety to be permitted for use as an ingredient in listed complementary medicines.

Once the substance is determined to be safe, it is included in the Permissible Ingredients Determination. In some cases, 'requirements' may be attached to the use of the ingredient in a listed medicine so that safety and quality can be maintained.

Once an ingredient is included in the Permissible Ingredients Determination, it may be used in any listed complementary medicine provided any requirements for use are complied with.

What applications do these changes apply to?

These changes only affect applications for evaluation of a substance for use in listed complementary medicines (which includes assessed listed complementary medicines).

Applications for evaluation of substances for use in sunscreens are not affected by this change.

What has changed?

New application categories

Applications for evaluation of a substance for use in listed complementary medicines are now categorised into four application levels (IN1, IN2, IN3 and IN4). Each application level has defined submission requirements. Less supporting information is required and shorter evaluation times apply to lower level applications.

Category Description
IN1 Evaluation of safety and quality based on evaluation reports from a comparable overseas regulator (COR).
IN2

Evaluation of safety based on evaluation reports from a COR.

Independent evaluation of quality by the TGA.

IN3

Evaluation of quality based on evaluation reports from a COR or a monograph contained in a default standard.

IN4 Full independent evaluation of safety and quality by the TGA.

For more information, please see Part C of the Australian Regulatory Guidelines for Complementary Medicines.

Legislative timeframes and new fees for applications

The associated fees and timeframes for each application level are outlined below.

Application level Total evaluation time (in days) Application fee Evaluation fee
IN1 70 $1,050 $14,000
IN2 120 $1,050 $14,000
IN3 150 $2,770 $22,900
IN4 180 $2,770 $22,900

For more information, please see Part C of the Australian Regulatory Guidelines for Complementary Medicines and the TGA Fees and Charges summary.

Exclusive use of new permitted ingredients

Successful applicants for new permitted ingredients may be granted 2 years exclusive use of that ingredient in listed medicines. During the exclusivity period only the applicant who requested evaluation of the substance (who may or may not be a medicine sponsor) or other persons nominated by the applicant will be able to use the ingredient to list a medicine.

The applicant will be able to grant additional sponsors access to the ingredient by contacting the TGA.

At the end of the exclusivity period, any sponsor can include the ingredient in a medicine and list that medicine in the Register.

For more information, please see Part C of the Australian Regulatory Guidelines for Complementary Medicines.

Upcoming changes - use of evaluation reports from comparable overseas regulators

Where possible, the TGA makes use of COR evaluation reports for evaluation of a substance for use in listed complementary medicines. As part of the Government's reforms arising from the Medicines and Medical Devices Review (MMDR) the TGA is developing:

  • A list of countries and jurisdictions from whom TGA will accept reports for use in the COR report-based process.
  • Transparent criteria for identifying CORs.
  • A process for using overseas reports.

Please note, COR evaluation reports that are provided for IN1, IN2 and IN3 applications must be from a list of CORs that is determined by the TGA under Regulation 16GJ.

A list of CORs and guidance on the use of COR reports will be available on the TGA website in 2018.

How do I apply for evaluation of a substance for use in listed complementary medicines?

Sponsors are encouraged to request a pre-submission meeting with the TGA to ensure that they are aware of the legislative requirements and the data required for an application to be accepted for evaluation.

Further information

If you have any further questions, please contact Complementary Medicines via phone on 1800 020 653 or via email at .