Australia's TGA seeks feedback on support needs for SMEs

Australian regulator the Therapeutics Goods Administration (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 trade group AusBiotech and industry.

AusBiotech says it 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.