TGA international engagement strategy: operations plan 2018-19

Greater interoperability between regulators will assist in combatting online trading and reduce the transit of counterfeit goods.

Activities planned for 2018-19:

• Enhance information exchange with Cambodia, China and India about illegal products entering Australia.
• Leverage of the FDA's advanced online trading capabilities and working towards interoperability between countries.
• In consultation with DFAT, update the China 2009 MoU.
• Develop Priority Target Profiles through improved regulatory intelligence cooperation with UK, China, India, Singapore and Thailand.

Influenza Essential Regulatory Laboratories (ERLs)

Laboratories are located in: Australia, Japan, UK and USA

In collaboration with the Global Influenza Surveillance and Response System (GISRS) network, the TGA contributes to the development, standardisation and regulation of influenza vaccines.

Activities planned for 2018-19:

• Produce, calibrate and make available reagents needed for use in the influenza vaccine potency assay.
• Perform serological studies using sera from human influenza vaccines and share the results to support influenza vaccine virus selection.
• Participate in the WHO vaccine composition consultations to review data generated by the GISRS and make recommendations on influenza vaccine composition for the next northern and southern hemisphere influenza seasons.

International Coalition of Medical Regulatory Agencies (ICMRA)

Further information about ICMRA is available from the ICMRA website

Throughout 2018-19, the TGA will continue to engage with ICMRA as Vice-Chair of the Coalition and participate with its working groups to build a global architecture to support information sharing, crisis response and address regulatory science issues. ICMRA's working groups include:

• Pharmacovigilance
• Communications Project
• Innovation
  • Horizon scanning methodologies
  • Novel approaches to licensing.

This work promotes efficient and informed, risk-based allocation of regulatory resources to avoid duplication of effort.

International Pharmaceutical Regulators Programme (IPRP)

IPRP will provide an environment for exchange of information on issues of mutual concern and foster greater regulatory cooperation across member regulators.

In collaboration with IPRP members, the TGA will work to promote convergence of regulatory requirements for new chemical and biological entities and generic medicines, identify emerging regulatory issues, align activities and share learnings. Over 2018-19, the TGA will be actively engaged with and/or monitor progress of IPRP's working groups:

• Quality for Generics
• Bioequivalence for Generics
• Information sharing for Generics
• Biosimilars
• Nanomedicines
• Gene therapy
• Cell therapy
• Identification of Medicinal Products.

Australia, Canada, Singapore, Switzerland (ACSS) Consortium

The goal of ACSS is to maximise international cooperation and reduce duplication.

The TGA's ongoing involvement with ACSS will allow us to progress the current information and work-sharing initiatives (details provided under Goal 2). ACCS working groups include:

• Generic Medicines
• Biosimilars
• Complementary Health Products
• New Chemical Entities
• Information Technology
• Future Strategy.

International Medical Device Regulators Forum (IMDRF)

The aim of IMDRF is to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices and to accelerate international medical device regulatory harmonisation and convergence.

Further information about IMDRF is available on the IMDRF website

IMDRF is an international forum to develop a globally harmonised approach to regulating medical devices, improve international standards, adverse event terminology and develop an unique device identification (UDI) system. The TGA will be actively engaged in a range of work throughout 2018-19, including:

• unique device identification (UDI) application guide
• personalised medical devices
• improving the quality of international medical device standards for regulatory use
• adverse event terminology
• good regulatory review practices
• regulated product submission

Details for these projects provided under Goals 2 and 3.

Pharmaceutical Inspection Cooperation Scheme (PIC/S)

Further information about PIC/S is available on the PIC/S website

As a foundation member, the TGA leads the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates for medicines.

Throughout 2018-19 work will progressing:

• quality risk management
• data integrity
• classification of deficiencies
• automated systems
• advanced therapy medicinal products (ATMPs)

Centre for Innovation in Regulatory Science (CIRS)

CIRS is an independent research organisation providing science-based insights to advance global regulatory and Health Technology Assessment (HTA) policies.

Further information about CIRS is available on the CIRS website

The TGA's involvement with CIRS, including as Vice Chair of Scientific Advisory Council, advances global regulatory science policies that enhance patient access to medicines.

CIRS also benchmarks the performance of major regulators through its Regulatory Review Times Database. These regulators include US FDA, EMA, PMDA, Health Canada, the TGA and Swissmedic. Throughout 2018-19, the TGA will provide metrics to the CIRS database about:

• the number of approved New Active Substances
• types of compounds and indications approved
• review types and designations
• timings of approvals.

Quality system audits of manufacturing facilities will include:

• ongoing QMS audits of High Risk Class III combination and other medical device manufacturers
• compliance verification/desktop assessment of audit reports from comparable regulators
• assessment of MDSAP conducted audit reports.

Ongoing information sharing of pharmacovigilance and signal investigation activities to strengthen TGA's regulatory intelligence with respect to provisionally approved medicines and biological medicines. Engagement includes:

• regular contact with FDA (USA), Health Canada (Canada), HSA (Singapore), Medsafe (NZ), SwissMedic (Switzerland) and MHRA (UK)
• International Society of Pharmacovigilance
• WHO Representatives of National Pharmacovigilance Centres.

International Medical Device Regulators Forum (IMDRF)

Working Groups

Adverse Event Terminology Working Group

Consistency helps when sharing information between participating regulators, industry and others. TGA will work with this IMDRF group to progress harmonisation of terms relating to the event type, evaluation, patient injury and device component. Broad consultations are planned prior to publishing documents on patient injury and device component terms.

National Competent Authority Report (NCAR) Exchange Program

Throughout 2018-19 TGA will continue to participate in this program to facilitate the exchange of information about medical device problems between participating regulators.

Over the year, we will continue developing processes for joint inspections with partner Regulators to reduce regulatory burden to industry. Activities will include:

• continuation of the collaboration program with Health Canada, including operationalisation of GMP inspections for Active Pharmaceutical Ingredients (API) manufacturers
• continued participation in the PIC/S Programme to rationalise international GMP Inspections of Active Pharmaceutical Ingredient (API) manufacturers with Australia, Canada, Denmark, France, Ireland, Italy, Japan, UK, USA, European Medicines Agency (EMA), and World Health Organization (WHO)
• continuing to upload of TGA inspection schedules into the planning module of the EudraGMDP database to facilitate joint inspection activities with other Regulators.

The TGA and Medsafe plan on continuing to meet monthly via teleconference. Outcomes inform evaluators and progress alignment efforts through:

• identifying issues of mutual concern
• sharing information on candidates entry to the new evaluation pathways
• continuing to share policy initiatives.

Review and update, where necessary, MRAs with other regulatory authorities to ensure manufacturing quality through:

• continued recognition of GMP Inspections performed and GMP Certificates issued by MRA authorities, in lieu of TGA physical on-site inspections for overseas sites manufacturing medicines and/or Active Pharmaceutical Ingredients (API)
• development of processes which allow the use of Health Canada inspections performed outside Canada for the TGA GMP clearance process, in lieu of physical on‐site inspections under the current Mutual Recognition Agreement with Health Canada
• inclusion of Active Pharmaceutical Ingredients in the Australia-Canada Mutual Recognition Agreement.

Engagement with the German regulator will progress harmonisation of requirements in regard to plasma master files (PMF) and vaccines and use of the annual PMF certification in Germany as a surrogate for TGA evaluation, in accordance with the MOU between the PEI and TGA.

Activities planned include:

• discussing the testing requirements for viral safety of vaccines, and specifically requirements for egg-derived inactivated Influenza vaccines
• discussing the mechanisms available for obtaining and using PEI assessments of viral safety for vaccines to improve the effectiveness of the TGA assessment process.

Invite Japanese regulators to discuss opportunities for formal confidence building and possible staff exchanges.

TGA will gain familiarisation with Japanese assessment reports and processes which will enhance potential for staff exchanges, formal confidence-building arrangements and report-sharing.

Work with Indonesia as required and in accordance with the established framework for collaboration, to exchange information in relation to:

• regulation of prescription, over-the-counter (OTC), complementary medicines and traditional medicines
• regulatory frameworks and processes for medicines classification/scheduling
• developent of on-the-job and short-term training
• evaluation of medicines of priority for public health.

Throughout 2018-19, the TGA will participate in the work of ISO's technical committees to develop standards for medical devices, including standards that underpin:

• quality management
• biological and clinical evaluation
• sterilization of health care products (see TC198 below)
• administration of medicinal products and catheters
• transfusion, infusion and injection, and blood processing
• non-systemic contraceptives and STI barrier prophylactics
• lung ventilators and related equipment.

Participate in Standards Australia's (SA) local standardisation committees. SA is Australia's nominating body to ISO and the local committees serve to ensure that ISO standards are suitable for use in Australia before they are adopted here. This work will influence standards for:

• medical electrical equipment
• surgical implants
• medical gas systems
• medical device quality systems
• diagnostics clinical laboratory testing and in vitro diagnostic test systems.

Participate on American Society for Testing and Materials (ASTM) committees and standards. ASTM standards are used to demonstrate compliance with Australian regulations.

ISO Technical Committee 198 (TC198)

Sterilisation of health care products

Standards and guidance documents developed by ISO TC198 are used internationally and within Australia by industry and regulators as an adjunct to Annex 1 Manufacture of sterile medicinal products to the PIC/S Code of GMP and as a basis for manufacturing standards for cell-based health care products.

Throughout 2018-19, the TGA will represent Australia at the ISO TC198 plenary meeting and technical meetings, as well as continue development of a range of ISO TC198 standards for:

• ethylene oxide sterilisation
• radiation sterilisation
• moist heat sterilisation
• packaging
• microbiological methods
• aseptic processing
• reprocessing of resterilisable medical devices
• washer-disinfectors
• assurance of sterility.

The TGA will participate in meetings with ICH Expert Working Groups to provide guidance on data requirements for BCS based biowaivers, including work on:

• an electronic common technical document
• a biopharmaceutics classification system
• the detection of toxicity to reproduction for human pharmaceuticals.

World Health Organisation (WHO)

• WHO Collaborating Centre for Drug Quality Assurance
• WHO Collaborating Centre for Quality Assurance of Vaccines and other Biologicals
• WHO Consultation of Quality Control Laboratory Tools and Specifications for Medicines
• International Non-proprietary Names (INN) Consultations

WHO's International Pharmacopoeia is a key source of pharmaceutical standards for developing countries and regions.

Planned activities for 2018-19:

• Successful re-designation of the Collaborating Centre for Drug Quality Assurance for the period 2019-2022.
• Successful re-designation of the Collaborating Centre for Quality Assurance of Vaccines and other Biologicals for the period 2019-2022.
• Finalise drafting monographs for moxifloxacin hydrochloride and moxifloxacin tablets.
• Ongoing work to contribute to the harmonisation of prescription medicine names. This reduces prescription errors, improves pharmacovigilance and provides savings for the PBS.

International Medical Device Regulators Forum (IMDRF)

Working Groups

Work to progress identification of commonly recognised standards and analyse differences on adoption/recognition between members.

Standards Working Group

• Progress the new project to update the list of international standards recognised by IMDRF members.
• Review and launch the guidance document "Optimizing Standards for Regulatory Use".

Personalised Medical Devices Working Group

• Develop guidance that establishes definitions and regulatory pathways for regulators to consider in the regulation of medical devices that are intended for individual patients.
• Promote global harmonisation in the terminology and premarket requirements for such devices.