The TGA is investigating ways that it might provide support for small and medium enterprises (SMEs) in accessing regulatory guidance, and seeks feedback on the key themes that emerged in initial discussions with AusBiotech and industry.
AusBiotech has been advocating for some time for greater support for SMEs in the form of a multi-channel program. Within the system, SMEs are at a disadvantage, due to lower internal capability and experience and activity that would substantially assist the start-up end of the industry spectrum and be of broader benefit to Australia’s efforts to nurture innovation. This change would also increase the effectiveness and efficiency of the regulator.
Larger companies and multinationals often have in-house regulatory expertise or can better afford consultant advice, but smaller companies, especially start-ups, are often confounded by the complexity of the system and ill equipped to seek specialist advice.
Following initial discussions with industry, the TGA has identified a number of areas where improved support could be provided, including:
- Educational and training resources, such as forums, webinars and written guidance;
- An SME-specific website/portal;
- Decision trees and other tools; and,
- TGA assistance services.
Specific feedback is sought to the following questions:
- If a program of education and training was developed, what would be the key topics of interest to SMEs? What would be the best way these could be delivered to meet SME needs?
- If a web portal that provided specific guidance and support for SMEs was developed, what would be the key topics and information that would assist? Should this information be targeted by topic or pathway?
- If tools that could answer a particular question were developed and made available, would this be useful? For example, a decision tree or flow chart to answer the question of whether or not a product/technology is a therapeutic good, or is a product a class I or class II medical device. If so, what other decision trees or flowcharts would be useful?
AusBiotech has welcomed the TGA’s approach to this support and contends that a better educated SME sector would be a nation-building activity for Australia. A program that helps educate young companies would be well received, support the industry’s growth, support faster approval of medicines and medical devices and avoid unnecessary re-work.
Feedback can be provided to AusBiotech’s Deputy CEO, Lorraine Chiroiu (email@example.com / 03 9828 1400).