Efficacy monographs for listed medicines

Closes 26 Feb 2021

Opened 22 Dec 2020

Overview

The Therapeutic Goods Administration (TGA) is seeking comment on two draft efficacy monographs that have been developed in response to Recommendation 46 from the Review of Medicines and Medical Devices Regulation (MMDR).

The purpose of this consultation is to provide an opportunity for relevant stakeholders and interested parties to provide feedback on the content, presentation and usability of two draft efficacy monographs for vitamins B6 and B12. These monographs document evidence which substantiates the use of these vitamins for particular indications which are appropriate for listed medicines.

In this consultation we are primarily seeking feedback on whether:

  • the content of the monographs is suitable for their intended purpose; and
  • the information included in the evidence statements is adequate to support the efficacy of the particular indications.

Why we are consulting

Listed medicines available for purchase in Australia are considered to be of relatively low risk to consumers. This group of medicines—which includes vitamins, minerals, sunscreens, herbal medicines and nutritional supplements—can be self-selected from pharmacies, health shops and supermarkets. They may only contain pre-approved low-risk ingredients and are only permitted to carry low-level indications about their effects. Although the efficacy of listed medicines is not assessed before they enter the market, the sponsor of the medicine must hold evidence to support these indications.

In March 2015, the Expert Panel conducting the Review of Medicines and Medical Devices Regulation (the MMDR review) recommended that the TGA develop, or adopt from comparable overseas regulators, efficacy monographs for commonly used active ingredients that have been approved for use in listed medicinal products. The Government accepted this recommendation with the aim of:

  • improving the availability and accuracy of information for consumers; and
  • reducing regulatory burden for industry.

In response to this recommendation, the TGA has undertaken the development of pilot efficacy monographs which are intended to assist sponsors in compiling the evidence that they are required to hold in support of indications for their listed medicines. They contain general background information about the relevant vitamin and an evidence statement(s) describing the information available to support its efficacy with regard to particular indications.

The TGA is now seeking your feedback to help refine the content of these monographs. The draft monographs may be accessed below under 'Related'.

The monographs are not intended to:

  • serve as a source of definitive information and advice to help consumers manage their health;
  • replace current clinical guidelines concerning uses of vitamin B6 or B12; or
  • negate the legal requirements of sponsors to ensure the compliance of their medicine(s) with all relevant legislation.

Make a submission

Audiences

  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Health professionals
  • HPRG (TGA) Staff
  • Complementary medicines

Interests

  • Regulatory policy