Technical Alerts

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey, open until 18 December 2022, is designed to inform the TGA about a sponsors medicine portfolio, pharmacovigilance system, inspection history and compliance with Australian pharmacovigilance legislation and guidelines, and will serve as a tool to help prioritise and schedule pharmacovigilance inspections of sponsors.

Please note: Any sponsors who has at least one medicine included on the Australian Register of Therapeutic Goods (ARTG) should complete this survey. medicine sponsors that do not complete this survey will be assigned the highest survey risk score, meaning you will have a very high chance of receiving a Pharmacovigilance Inspection under the TGA's PVIP.

The survey questions relate only to medicines (not medical devices or biologicals) in the ARTG including all listed, registered and provisionally registered medicines.

Sponsors are directed to complete and submit their survey responses online; the survey consists of 24 questions and must be completed in one attempt only. Partially completed surveys will not be recorded and cannot be retrieved for later use.

The TGA request that stakeholders answer the questions carefully and truthfully as they may ask for evidence of responses during a pharmacovigilance inspection. A copy of the survey questions is available to assist stakeholders prepare their responses prior to submission.

• TGA website: Pharmacovigilance Inspection Program Risk Assessment Survey
• TGA Survey questions
• Respond here
• TGA website: Pharmacovigilance inspection program: Guidance for medicine sponsors
• FAQs: Pharmacovigilance obligations of medicine sponsors

The TGA is seeking feedback, via online survey closing 20 November 2022, on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’. 

The existing guidance is out of date and requires updating to reflect significant changes in the regulation of therapeutic goods since 2005. The purpose of the draft guidance is to assist sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices, providing clarity on which regulatory pathway is appropriate for therapeutic goods which are considered Boundary and combination products.

The draft guidance also reflects the recent changes to Class 1 medical devices, as part of the ongoing medical device reforms, and raises other areas relevant to listed and complementary medicines such as head lice, lozenges and nail fungus products.  

Please read today’s full tech alert for more information, including a comparison of the 2005 guidance and the draft guidance, and details on how to respond to the consultation.

Today's technical alert provides information on the Therapeutic Goods Advertsising Annual Report 2021-22; and the TGA update to the approach to overseas manufacturers during the OCVID-19 Pandemic: GMP Clearance MRA pathway.

Therapeutic Goods Advertising Annual Report 2021-22

The annual outcomes of the TGA’s 2021-22 advertising compliance and enforcement activities have been published in the Therapeutic Goods Advertising Annual Report 2021-22 on the TGA website. This tech alert provides contextually relevant information for members, including in relation to listed and complementary medicines. 

TGA update to the GMP approach to overseas manufacturers during the COVID-19 Pandemic: GMP Clearance Pathway 

The TGA have provided an update their GMP approach to overseas manufacturers during the COVID-19 Pandemic, which outlines additional options for Australian Sponsors to maintain their GMP Clearance validity and provides additional application guidance.

Please read today’s full tech alert for more information.

Registration is now open for a USP live webcast on nitrosamine impurities, to be held on 13 October 2022. More information and details on how to register are available via this USP web page. 

CMA’s 27 July technical alert provides more background and context for members.

Course Description:

This one-day course will provide attendees with an understanding of current regulatory guidelines and USP General Chapter <1469> Nitrosamine Impurities. The course will provide an overview of sources of nitrosamines including their formation from the presence of other impurities and how to eliminate or reduce levels of nitrosamines. Tools to assess and control nitrosamines in drug substances and drug products as well as in depth analytical procedures in USP <1469> including the use of the USP Reference Standard and precautions to be used during procedures will also be covered. The course will also address risk assessment methodology as per ICH9, control strategy development, calculation of nitrosamine limits as per ICH M7 as well as test method performance characteristics.

Upon completion of this course, attendees will be able to: 

 - Describe the background, scope and approach of USP <1469> Nitrosamine Impurities and applicable regulatory guidelines.

 - Explain pathways and sources of nitrosamine formation along with risk assessment tools and a high- level process flow to develop control strategies.

 - Describe how to select the appropriate analytical procedures based on test method performance characteristics for nitrosamine methods

 - Discuss the proper use and handling of the USP reference standard in the respective analytical procedures.

 - Identify factors which impact sensitivity and selectivity of methods

 - Summarize key considerations, challenges and method conditions along with sample and standard preparation of the four test methods described in USP <1469>

Who should participate:

 - R&D manufacturers

 - QC managers

 - QC staff scientists (DS, DP)

 - Excipient manufacturers

 - Research scientists

 - QA staff who authorize drug product release

Two TGA consultations have recently been announced:

Regulatory options to potentially allow references to the TGA in therapeutic goods advertising

This Public Consultation, closing 7 November 2022, considers potential options on whether allowing references to the TGA in therapeutic goods advertising (and on product labels) may support consumers to make better informed health decisions by more clearly identifying products that have met the regulatory requirements and are being lawfully advertised and sold.

The TGA are seeking feedback on:

- whether references to the TGA should be allowed in therapeutic goods advertising the class or classes of therapeutic goods, if any, that should be allowed to refer to the TGA;

- options for what a reference to the TGA could look like;

- options for how an authorised reference to TGA may be used in advertising; and

- whether references to TGA should be optional or mandatory for advertisers.

DAEN user experience survey

This online survey, closing 26 October 2022, is seeking feedback on stakeholder experience of the beta version of the database of adverse events notifications (DAEN), providing the opportunity for stakeholders to identify any areas of the beta version that are problematic or not fit for purpose prior to implementation.

Please read today’s full technical alert for more information and details.

Members are reminded that the end of the transition period for existing products that contain Vitamin B6, certain Artemisinin containing ingredients and Mollusc-derived ingredients is 28 Feb 2023. Sponsors have been provided a 12-month transition period from 1 March 2022 to bring existing listed medicines into compliance. From 1 March 2023:

- The maximum recommended daily dose (MRDD) for products that contain vitamin B6 has been changed to 100 mg pyridoxine/day. Existing products that contain vitamin B6 must include a warning statement if the medicine contains more than 10 mg of pyridoxine per maximum recommended daily dose (MRDD).

- Existing products that contain certain Artemisinin containing ingredients must include a pregnancy warning statement.

- Existing products that contain Mollusc derived ingredients must include a new warning statement.

Please read today’s technical alert for more details

The TGA have published new Guidance for ASX announcements.

Listed and unlisted companies have continuous disclosure obligations under the Corporations Act 2001 for listed and unlisted companies are to ensure market integrity and investor protection. ASIC can issue infringement notices for breaches of these obligations.

The TGA have developed guidance to assist companies understand and comply with the requirements for advertising therapeutic goods when making announcements to comply with their continuous disclosure obligations, and ensure they do not constitute advertising therapeutic goods to the public. The guidance also provides examples of what the TGA may and may not consider to be advertising material – which continues to be regulated by the TGA.

This piece was developed in response to entities claiming that certain posts on social media etc. were to meet continuous disclosure requirements, when social media posts are generally considered advertisements if about therapeutic goods and not continuous disclosure announcements.

Please read today’s full tech alert for more details.

The TGA has released a Scheduling Consultation on amendments to the Poisons Standard, which includes a proposal for a warning on Green Tea Extract on most consumer products (both therapeutic goods and other goods), and a proposal to make a new Schedule 3 Melatonin entry available for jetlag. The Consultation is open now, closing 29 September 2022.

The proposed amendment for Green Tea Extract not only includes a label warning for medicines and other products for internal use that are available for general sale, but also will change requirements, including transition dates, for any foods or supplements (including sports supplements in liquid, powder, capsule or tablet form) that contain Green Tea Extract due to the influence of the Therapeutic Goods (Declared Goods) Order 2019.

Please read today's full technical alert for more information and details. 

The TGA has launched their new website at midnight on 30 August. The new site is intended to provide users with a more streamlined way to search for and access relevant information.

The new website aims to deliver on improvements to:

- how the website looks and works so it's easier to find and understand the information you need;

- navigation and search so you can find what you need faster;

- follow Government best practice; and

- move old website content to be archived on the National Library of Australia web archive  (TROVE).

Today's technical alert provides more details for members, including information accessing archived TGA content and superseded guidances (where relevant for historical purposes) on the National Library of Australia web archive (TROVE) and some limited documents on the CMA website.

The TGA has published the annual low-negligible risk public consultation paper for changes to the Permissible Ingredients Determination, closing 15 September 2022.

The proposed changes relate to:

 - Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata; and 

 -Liver injury associated with Valeriana officinalis.  

The consultation proposes applying a new warning statement for Valeriana officinalis and an updated warning statement for Chelidonium majus and Larrea tridentata which are essentially the same except for the required name of the herb.

Please read today’s full technical alert for more details and additional contextual information.