Technical Alerts

The TGA have published a half yearly performance snapshot on their website. The snapshot provides statistical information for the period 1 July 2020 to 31 December 2020 in relation to the TGA's regulation of therapeutic goods.

Please read today’s technical alert for more information specific to Listed, Assessed Listed and Registered complementary medicines, including statistics related newly approved applications, complementary medicine laboratory testing and the pharmacovigilance inspection program.

As part of the review of the Food Regulation System, the Department of Health have opened a consultation, closing 18 May 2021, to seek stakeholder feedback on the Review of the Food Standards Australia New Zealand Act 1991 (the Act)-draft Regulatory Impact Statement (RIS), and to provide feedback to characterise the impact of three proposed options within the RIS.

This consultation represents the potential for significant change within the food regulatory system, as the Act has been in place for almost 30 years, with few amendments over that time. The data, commentary and information received through this consultation will be analysed to inform a final RIS, which will be used to inform any amendments to the FSANZ Act.

Please read today’s member alert for more information about the consultation, including the proposed options and how to respond.

Two separate consultations are now open on proposed changes to required advisory statements for Registered complementary Medicines containing menthol and methyl salicylate, closing on 18 May 2021.

The TGA is seeking comment on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing either menthol or methyl salicylate for dermal use, for inclusion in the Required Advisory Statements for Medicine labels (RASML).

The proposed changes apply only to registered medicines. requirements for menthol and methyl salicylate for listed medicines have already been implemented and are included in the Permissible Ingredients Determination.

Please read today’s technical alert for more information, including details on how to respond to the consultation(s).

The Food and Beverage National Manufacturing Priority road map was launched on 29 March 2021. projects in this area are now eligible to apply under the Integration and Translation Streams of the $1.3 billion https://www.industry.gov.au/data-and-publications/make-it-happen-the-australian-governments-modern-manufacturing-strategyModern Manufacturing Initiative (MMI). 

Applications for the Integration and Translation Streams of the MMI close 27 April 2021 5pm (AEST). 

MMI investment will be guided by the Food and Beverage National Manufacturing Priority road map. The road map highlights areas of investment opportunity including: enhanced processing and packaging methods, products for health and wellbeing and enhanced nutritional value, high value-add products, products with strong food safety, origin and traceability systems and the adoption of new solutions to increase product differentiation.

The Department of Industry are holding an information session on funding opportunities for Food and Beverage manufacturing projects tomorrow, Wed 31 March 2021, 2pm-3pm (AEDT). Sign up here. 

The TGA has introduced a new standard for serialisation of medicines and use of data matrix codes; the TGO 106 - Therapeutic Goods (Medicines - Standard for Serialisation and data Matrix Codes) (TGO 106) Order 2021).

The Order does not mandate the use of data matrix codes or serialisation of medicines in Australia, but is designed to put in place minimum technical requirements to ensure the effectiveness and functionality of serialisation and data matrix codes, where sponsors intend to use such technology for medicines supplied in Australia.

Please read today’s amended technical alert for more information and details, including when the requirements of the Order do and do not apply.

Applications for the first round of Medical Product national Manufacturing Priority funding are closing today.

The Modern Manufacturing Initiative for medical product manufacturing projects that meet eligibility under its Translation and Integration streams CLOSES TODAY, March 29, at 5pm (AEDT). Please ensure your application is finalised by the specified time as there will be no extensions. 

- The Manufacturing Translation Stream provides businesses with funding to support projects that translate high quality research into commercial outcomes and support businesses to scale-up and be more competitive and resilient. It provides co-funding to support businesses to adopt new technologies and improve their manufacturing processes to boost productivity and competitiveness. For questions on the MMI Translation stream please email mts@industry.gov.au

- The Manufacturing Integration Stream supports projects that integrate Australian business into domestic and international value chains, propelling their goods and services into new markets. It provides co-funding to encourage linkages between local business and domestic and international firms, increasing scale, supply capacity and the ability to innovate. It will also facilitate the adoption of product standards and greater sharing and transfer of knowledge. For questions on the MMI Integration stream, please email mis@industry.gov.au   

Members can contact AusIndustry via phone (13 28 46) if they have any further questions about their application.

Please also read CMA’s 26 February member alert for more information, including eligibility criteria and how to apply,

The new $30 million Commercialisation Fund under the Modern Manufacturing Strategy is now open for applications.  

The Fund will support project collaborations between industry and research partners by providing matched grants to Australian manufacturers to assist with commercialising new products and processes.

The Fund will run over an 18-month period, with the first round of funding (opened today) providing $20 million, and a subsequent round delivering the remaining $10 million.

Please read today's member alert for more details, including eligibility criteria and how to apply.

A new Permissible Ingredients Determination (No. 1) 2021 has commenced.

This technical Alert (available in Word and PDF) contains a detailed list of changes with a Notes field for sponsors to use to assist in identifying the changes relevant to products, as part of a table which includes:

 - Each new or changed ingredient

 - The original (previous) requirements that applied

 - New (amended) specific requirements

This update also includes information on the following substances with more context provided for members on background information leading to the changes:

 - Updates to applicable requirements for inorganic magnesium salts, Andrographis paniculata and caffeine 

 - Removal of Gynura japonica 

The Modern manufacturing Initiative is now open for medical product manufacturing projects that meet eligibility under its Translation and Integration streams. Applications for both streams close on 29 March 2021 5pm (AEDT).

 -The Manufacturing Translation Stream provides businesses with funding to support projects that translate high quality research into commercial outcomes and support businesses to scale-up and be more competitive and resilient. It provides co-funding to support businesses to adopt new technologies and improve their manufacturing processes to boost productivity and competitiveness.

 - The Manufacturing Integration Stream supports projects that integrate Australian businesses into domestic and international value chains, propelling their goods and services into new markets. It provides co-funding to encourage linkages between local businesses and domestic and international firms, increasing scale, supply capacity, and the ability to innovate. It will also facilitate the adoption of product standards and greater sharing and transfer of knowledge.

Please read today's member alert for more information, including eligibility criteria and how to apply.

Subscribe to manufacturing Strategy Updates here.

The NHMRC are conducting a Review of the 2013 Australian Dietary Guidelines, a multi-phase process with the final step resulting in publication of updated Dietary Guidelines in 2024. 

The current guidelines make community recommendations on dietary sources and approach to fruits, vegetables, salt, sugar, processed foods, types of fats etc. As part of the review process, NHMRC will consider how the current Guidelines are used and who is using them. Feedback from stakeholders, including those involved in product research and development, manufacturing and marketing is sought.

As part of their primary scoping activities to ensure relevant information is considered and prioritised for inclusion in the review, the NHMRC have published a scoping survey on their website and are seeking comments on:

 - how the 2013 Australian Dietary guidelines are used; and 

 - topics to be considered and possibly in the review of the  Guidelines.

The survey closes 3PM (AEDT) on 15 March 2021. Questions are a combination of multiple choice and open-ended questions and the survey will take approximately 15 minutes to complete. Responses will be collected anonymously, combined and the results published on the NHMRC website. 

Following the conclusion of the scoping survey, the NHMRC will establish and appoint members to an Expert Committee to provide advice. the Expert Committee will be provided with the survey findings which will assist members to determine the priority topics for review. the Expert Committee will also prepare the research questions, support review of evidence and draft updated Guidelines.

For more information, timelines, and to subscribe to keep up to date with the latest Review, ant to access the Dietary Guidelines Stakeholder Consultation Plan and scoping survey, please click here.

For more information on this survey, please contact the NHMRC Dietary Guidelines team:dietaryguidelines@nhmrc.gov.au