Author: Piety Rocha, Director, Head of Regulatory Affairs Team & VDC Country Head
The global pharmaceutical market presents both opportunity and challenge. To efficiently maneuver through ever-changing regulations, guidelines and government policies that differ across jurisdictions, companies must maintain agile and resilient operations.
Different requirements at the local level places a huge burden on companies, on public health and, in particular, on local affiliate offices, which must navigate the risks involved in sustaining revenue while keeping maintenance costs low and, crucially, meeting their obligations to local regulations[i].
There have long been efforts to drive greater harmonization of global regulatory activities to streamline the activities that local affiliates perform, and the different approaches to drug and device regulation depending on market or region[ii]. At the same time, there continue to be barriers to harmonization including the experience of various agencies, technology and, in some cases, insufficient resources[iii].
A step toward convergence
Nevertheless, some regions have been making progress toward a convergence of activities. One such region is Australia, under the Therapeutic Goods Administration.
Real collaboration with other health authorities is fairly new to the TGA, and it wasn’t that long ago that the agency performed a full assessment of data demonstrating safety, efficacy and quality for all new product registrations. Today, with increased transparency, the emergence of new technologies, greater regulatory collaboration and alignment of regulatory requirements, there appears to be a more unified approach ensuring timely access to medicines[iv]. The TGA has since taken steps beyond harmonization to embrace real cooperation[v]. This is where true change will happen.
Understanding Australia’s regulatory pathways
By way of background, Australia has five regulatory pathways for new prescription medicines: 1) the standard pathway, 2) the priority review pathway, 3) the provisional approval pathway, (4) Comparable Overseas Regulator (COR) Pathway A and (5) Comparable Overseas Regulator (COR) Pathway B[vi][vii].
The provisional approval process allows certain medicines to be provisionally registered in Australia for a limited duration on the basis of preliminary clinical data, where the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
The priority pathway provides a formal mechanism for faster assessment of vital and life-saving prescription medicines with a target timeframe of 150 working days.
The COR pathway initiative reduces the evaluation review timelines based on leveraging another regulator’s approval and evaluation documentation. The COR regulators are Canada, Japan, Singapore, Switzerland, United Kingdom, United States and the European Union.
In the COR A Pathway, submission must be within 12 months of the COR regulator’s approval and is evaluated 120 working days from acceptance into evaluation.
COR B Pathway has no time limit within which the application can be submitted and is evaluated 175 working days from acceptance into evaluation.
That is significant progress as compared to the standard pathway evaluation timeframe of 255 working days.
Cross-health authority collaboration
One of the most notable programs adopted by the TGA is Project Orbis, an initiative of the FDA Oncology Centre of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international regulators[viii]. Project Orbis has facilitated collaboration amongst selected other agencies including Australia, Canada, Switzerland, Singapore, Brazil and the UK.
Australia also participates in the Access Consortium, which is a coalition of regulatory authorities across Health Canada, the Health Sciences Authority of Singapore, Swissmedic, and the UK’s MHRA[ix]. The goal of Access is to maximize international cooperation, reduce duplication, and increase each agency’s capacity to ensure consumers have timely access to high-quality, safe, and effective therapeutic products.
According to the TGA, the Access pathway, besides building synergies, offers:
- Streamlined process – internationally coordinated review to reduce duplication and burden
- Increased access – possibility of simultaneous access to markets of multiple countries
- Flexibility – adaptability in how regulators organise collaboration amongst each other on a given review and which countries a company chooses to submit applications
- Predictability – pre-determined milestones and targeted review timeframes
Removing global regulatory complexity
In a complex global regulatory environment, finding ways to reduce those complexities at the local affiliate level is increasingly important in order to avoid regulatory missteps, delays and other pitfalls that could jeopardize registration of new medicine. Exploring options and new frameworks through which to operate will become a greater priority.
[i] The need for global regulatory harmonization: A public health imperative, Science Translation Medicine. May 2016. https://www.science.org/doi/10.1126/scitranslmed.aaf1396
[ii] ICH, harmonisation for better health. https://www.ich.org/
[iii] Barriers and Challenges for Global Regulatory Harmonization, Informaconnect, July 2020. https://informaconnect.com/barriers-global-regulatory-harmonization/
[iv] Therapeutic Goods Administration International Engagement Strategy, Operations Plan 2018-19. Australian Government Department of Health. https://www.tga.gov.au/sites/default/files/tga-international-engagement-strategy-operations-plan-2018-19.pdf
[v] International cooperation, Australian Government Department of Health and Aged Care. https://www.tga.gov.au/about-tga/international/international-cooperation
[vi] Fast track approval pathways. Australian Government Department of Health and Aged Care. https://www.tga.gov.au/fast-track-approval-pathways
[vii] Comparable overseas regulators (CORs) for prescription medicines, Australian Government Department of Health and Aged Care. https://www.tga.gov.au/sites/default/files/comparable-overseas-regulators-cors-prescription-medicines.pdf
[viii] Project Orbis, Australian Government Department of Health and Aged Care. https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good-0/supply-prescription-medicine/application-process/comparable-overseas-regulators/project-orbis
[ix] Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium, Australian Government Department of Health and Aged Care. https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium
