Asia-Pacific Roundup: TGA seeks feedback on planned changes to listed medicine guidelines

RoundupsRoundups | 08 March 2022 |  By 

Australia’s Therapeutic Goods Administration (TGA) has proposed a near-total overhaul of its guidelines on how to demonstrate the efficacy of listed medicines and released its draft for consultation.
In Australia, the term “listed medicine” covers unscheduled products with well-known, low-risk ingredients, usually with a long history of use. The category allows companies to bring products such as vitamins and minerals to market without undergoing premarket assessment, typically for self-selection and self-treatment by consumers. TGA then conducts post-market compliance reviews to determine if listed medicines meet the listing requirements.
The postmarket requirements include possession of appropriate evidence to substantiate the indication and the ability to show TGA that the efficacy of the medicine is acceptable. TGA last set out what that means in practice for manufacturers of listed medicines in 2019. Now, TGA plans to update the guidelines.
“The purpose of this update is to enhance the readability and utility of the Guidelines; clarify the way the TGA interprets and analyses the different types of evidence; and clarify specific technical concepts that have been problematic or unclear in the existing Guidelines,” TGA wrote.
While the update is “not intended to change the regulatory requirements for listed medicines and will not change the existing requirements to substantiate indications,” TGA said “it is inevitable that some clarifications may appear to be a change to some readers, given that the previous lack of clarity would have resulted in different interpretations.”
TGA now wants to know if the revised introduction adequately explains “why a sponsor needs to provide a critical analysis of their evidence in an evidence package for their listed medicine,” and if a subsequent section on how to find evidence is “helpful in guiding you to conduct and document a literature search.”
The agency also is seeking feedback on its plans to restructure a section on how to assess the relevance and quality of evidence sources. The current guidelines divide evidence into “primary” and “secondary” sources. TGA now thinks those terms “allowed for confusion given the terms can have different meanings depending on their context,” leading it to propose replacing them with three categories.
In the draft, TGA divides scientific evidence up into Category A, B and C. Category A covers double-blind, randomized controlled trials and systematic reviews. Observational and comparative studies fall into Category B, with Category C reserved for generalized reviews and other “evidence types can be more affected by bias.”
TGA is accepting feedback on the proposal until 1 April.
TGA Consultation
India adds the UK to list of territories that offer a shortcut to import licenses
The Indian government has added the UK to the list of countries that offer importers of medical devices a fast track to the granting of an import license. India previously covered the UK as part of the EU.
The change affects the section of the Medical Device Rules, 2017 that deals with the granting of licenses to import products into India. Typically, India grants import licenses after examining documents filed through an online portal and reviewing the inspection report. However, importers with certificates of free sale from certain jurisdictions can obtain licenses without undergoing clinical investigation.
India previously lowered the bar for obtaining an import license for companies that have been issued a free sale certificate “in respect of any medical device by the national regulatory authority or other competent authority” in “Australia, Canada, Japan, European Union Countries, or the United States of America.”
Free sale certificates granted by UK authorities were previously covered by the provision. However, with the UK no longer falling under the umbrella term “European Union Countries” because of Brexit, India has needed to update its rules to make it easier for companies with free sale certificates from the region to obtain import licenses.
Gazette Notification
TGA finds more counterfeit ivermectin, warns consumers
TGA has cautioned consumers about counterfeit ivermectin after finding two imported unregistered medicines that contained less of the active ingredient than claimed on the labels.
Both products, Iverheal-12 and Iverjohn-12, are labeled as containing 12 mg of the active pharmaceutical ingredient ivermectin. Laboratory testing revealed otherwise, leading TGA to call the products counterfeit and advise consumers to be cautious about products that are sold by unverified online stores.
The warning follows a December 2021 alert about three ivermectin products, Iversun-12, Covimectin-12 and Ivilife-12, that TGA also found to be counterfeit.
TGA is working with the Australian Border Force to target counterfeit ivermectin entering the country. The collaboration grew out of evidence that some consumers are interested in self-medicating with the antiparasitic medicine to prevent or treat COVID-19. TGA “strongly advises” Australian consumers against self-medicating with ivermectin, adding that counterfeits are a “significant public health and safety risk.”
TGA Notice
Malaysia’s MDA warns it will drop filings if applicants miss payment deadline
Malaysia’s Medical Device Authority (MDA) has warned its new online system will automatically drop submissions if the applicant fails to pay the associated invoice within 60 days.
MDA recently launched MeDC@St 2.0+, the latest iteration of a centralized online application system that first came online in 2013. The regulator upgraded the system in 2019 and again at the start of last month, adding features related to change notifications, clinical research and the payment of invoices.
The new payment module allows applicants to pay via credit card, as well as the existing options of bank draft and Malaysia’s online FPX service. However, the new system also poses strict restrictions on the deadline for paying invoices.
“All payment in MeDC@St 2.0+ system must be made within 60 days from the date of invoice generated enforced on 1st February 2022. Failing to do so, the current application will automatically be dropped from the system and a new application has to be made,” MDA said last week. MDA had previously said applicants would have 30 days to settle their invoices.
MDA Notice
TGA issues fine over unlawful advertising of TENS device
TGA has fined Healy World Australia AU$26,640 ($19,430) over the alleged unlawful advertising of a transcutaneous electrical nerve stimulation (TENS) device. Healy World Australia is accused of breaching the Therapeutic Goods Act 1989.
Sydney-based Healy World Australia is the sponsor of a TENS medical device included in the Australian Register of Therapeutic Goods (ARTG). TGA has accused Healy World Australia of advertising the device for a purpose other than that covered by the ARTG entry. The “conduct amounts to false advertising,” TGA said.
TGA also alleged Healy World Australia’s “advertising contained a prohibited representation about the TENS device, being a reference to a serious condition, with references to depression, anxiety and associated sleep disturbances, without the relevant regulatory permission.” TGA used its notice about the fine to remind sponsors of their ongoing responsibilities after a device is added to the ARTG.
TGA Notice


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you