Technical Alerts

In response to CMA's advocacy on permitted indications, the Government are currently seeking multi-level policy approval for a 12 month extension of the fee-free period for changing listings to permitted indications.

Due to the required approvals and legislative processes, it is not expected that this can be finalised before the current cut-off date of the 6 September 2019, however, if the approvals are underway, it is unlikely the TGA will switch on the fees from that date.

Thank you members for your support to-date and we will send more information as it becomes available.

Changes will soon be made to the Permissible Indications Determination including
•    addition of 4 new indications
•    changes to 32 existing indications to clarify/correct the wording of indications and/or indication requirements, including label warning statements.
The details of these changes are contained in today's technical alert.

A Liaison fee will be required for all GMP clearance applications that use Canadian Inspection Exit Notices as evidence for compliance verification.

The 2nd GMP Forum will be held in Melbourne on Thursday 21 November 2019.

The TGA publishes a reminder for sponsors of sports supplements to be aware of their regulatory status and obligations.

Read more in this week's technical alert.

Changes to the regulation of nappy rash products will be implemented on 1 January 2020.

CMA is a founding member of the new Naturopathic Council of Australia (NCA), a co-ordinating body to represent the naturopathic profession.

Details of changes relevant to complementary medicines and further information about the NCA are in today's technical alert.

Amendments to the Therapeutic Goods Advertising Code have been registered on the Federal Register of Legislation. The amendments are minor, but primarily relax some of the requirements that were causing impediments to advertisers of complementary medicines, and are effective as of 30 July 2019.

Details of changes relevant to complementary medicines and the highlighted changes to each section of the Code are included in today's technical alert.

Updated guidance has been published by the TGA to support sponsors in applying the requirements of TGOs 91and 92.

The 2nd Annual GMP forum is open for registrations.

Two more compositional monographs have been published by the TGA for Resveratrol and Calcified Lithothamnion species.

For full details and links, members may view today's technical alert here.

Turmeric, Black Cohosh, and Green lipped mussel are in the spotlight for possible adulteration or contamination issues. These are or will be the focus of TGA Laboratory testing programs for listed medicines.

Members should be aware that under MMDR reforms, the TGA are taking a tougher stance across all therapeutic goods industries, and therefore it is likely that any negative findings would result in compliance or enforcement actions.

Testing may occur for synthetic dyes, heavy metals including lead, and other possible contaminants, as well as correct herbal species identification by chromatographic profiling.

As foreshadowed at the CMA Innovation Day, the online database HPTLC Atlas, or 'International Atlas of HPTLC Methods of Identification of Herbal Drugs', has now been launched by the International Association for the Advancement of High Performance Thin Layer Chromatography. Information is searchable and available for free download.

For full details and links, members may view or download today's technical alert here.

The TGA have released three publications:

• guidance regarding applications and permission to use restricted representations in advertising;
• e-learning modules to assist sponsors in using permitted indications in their listings; and
• a compositional guideline for Streptococcus salivarius.

Members can read more about these publications in today's technical alert  here.

The TGA Laboratories will be testing herbal medicines that may contain arbutin. The limit of arbutin in therapeutic goods that are finished products is 25ppm. Below this concentration, supply is legal, above this concentration, products would face regulatory compliance actions.

Please note that the down-scheduling application for arbutin remains under TGA assessment and will not be finally determined until 2020 or 2021.

The TGA have provided safety alerts in relation to two herbs, Vitex agnus-castus and the potential for interaction with oral contraceptives pills, and the Chinese medicine herb Fallopia multiflora (he shou wu) in relation to cases of adverse liver events.