Section navigation

• Overview
• Advertising Services
• Call For Comment
• Scientific, Technical & Regulatory
  • Brand Extensions
  • Crisis Management
  • Consumer Medicine Information
  • Data Protection and Market Excusivity
  • GMP
  • Interface Issues
  • Links
  • Labelling
  • Meeting Minutes
  • Packaging
  • Scheduling & Switch
  • Sunscreens
  • TGA Performance Reports
• Key Documents
• Market Data
• Quality Use of Medicines
• Self Care
• Consultants and Services
• Submissions and Discussion Papers

Scientific, Technical and Regulatory

ASMI's Scientific, Technical and Regulatory team (STAR) monitors technical and regulatory developments in Australia and around the world and disseminates the information to our members. The team participates in many meetings at government level and also facilitates several ASMI Subcommittees with the aim of ensuring that our members' views and interests are taken into account in the development of Australian regulatory policy.

The STAR team is available to provide advice and guidance to members.

The following paragraphs explain the operation of the Scientific, Regulatory and Technical committee and subcommittees:

Regulatory Policy Subcommittee

The Regulatory Policy Subcommittee is responsible for identifying regulatory issues which may influence industry’s:

• ability to advance the role of self-care as an essential element of a national health policy
• capacity for growth and innovation.

Its primary focus is the policies and factors which determine or influence the regulatory environment around self care. These include the National Medicines Policy, national health policies, National Health Priority Areas, and policies determining the regulation of therapeutic products and products at the interface – cosmetics and foods.

The task is to develop and implement influence strategies that will shape policy reforms. The key objectives are the expansion of self-care, minimum effective regulation and a level regulatory playing field across relevant industry sectors.

The Subcommittee also provides technical support (with assistance of the Working Groups and Teams) to the Committee of Management and Secretariat in their activities to further the interests of ASMI, its member companies and the consumer self-care products industry generally.

Deon Schoombie is the Secretariat contact for this committee.

Working groups functioning under the auspices of the Regulatory Policy Subcommittee

OTC Working Group

This Working Group is responsible for addressing issues arising from current regulatory requirements applicable OTC medicines and products at the interface. The key objectives are to identify problem areas and propose solutions, to contribute to initiatives to improve regulatory guidelines and practice, to ensure consistency, predictability and efficiency in relation to regulatory functions and activities.

Catherine Gwynne is the Secretariat contact for this group.

Complementary Medicines Working Group

This Working Group deals with issues arising from current regulatory requirements applicable to complementary medicines and products at the interfaces where appropriate. The main aims are to identify problem areas and propose solutions, to initiate and/or support initiatives to improve the regulatory framework, to ensure consistency, predictability and efficiency in relation to regulatory functions and activities applicable to complementary medicines.

Ruth Kendon is the Secretariat contact for this group.

Manufacturing Working Group

This Working Group addresses issues relating to all aspects of the regulatory scheme applicable to the manufacture of self-care products – GMP and quality control. The W/G participates in identifying problem areas and propose solutions, to initiate or support initiatives to improve the regulatory GMP framework to ensure the quality standards of the industry are improved with minimum effective regulation and while maintaining a level playing field. The W/G is also responsible for identifying members’ requirements for additional support through information sessions, e.g. workshops, seminars, etc.

Catherine Gwynne is the Secretariat contact for this group.

Scheduling Working Group

The W/G is responsible for developing initiatives to increase consumer access to self-care products, including the development of an ASMI switch strategy. It responds through a whole-of-industry approach to scheduling issues in relation to therapeutic categories, and where appropriate, specific substances in as much as these may effect industry more broadly. The W/G addresses process and policy issues to improve the functioning of the scheduling scheme, including the NCCTG and NDPSC, and pursues harmonisation of scheduling across all jurisdictions.

Deon Schoombie is the Secretariat contact for this group.

Consumer Information Team

The Team works on all aspects of labelling, including label statements for medicines and packaging requirements where appropriate. It actively promotes the adoption of performance based labelling by members and industry generally and it collaborates with other stakeholders to improve information provision to consumers through CMI, PI, leaflets, web based and other vehicles – the main objective is to improve QUM.

Mary Emanuel is the Secretariat contact for this team.

Analgesics Team

The Team monitors local and international developments and provides guidance to ensure appropriate levels of regulation to optimise the environment for supply of these products.

Deon Schoombie is the Secretariat contact for this team.

Sunscreen Team

The Sunscreen Team monitors, assesses and makes recommendations on issues arising from the regulation of sunscreens to ensure the development of appropriate standards and levels of regulation. This includes the regulation of products at the cosmetic interface.

Catherine Gwynne is the Secretariat contact for this team.
 

Paediatric Cough/Cold Team

This ad hoc team was established to deal with the threat that has emerged globally to the paediatric cough/cold category. The team is responsible for monitoring local and international developments in relation to the regulation of these medicines and to develop strategies to protect the category and maintain appropriate consumer access to these products. The team also works with the TGA to ensure full and transparent consultation and to negotiate transition arrangements that would cause minimum disruption to business.

Catherine Gwynne is the Secretariat contact for this team.

Data Protection Team

The Team is responsible for providing guidance and assisting the Secretariat in the development of strategies to support ASMI’s initiatives that will result in the introduction of data protection provisions in the regulatory framework for consumer self-care products.   For further information see Data Protection and Market Exclusivity.