141 ISBT Science Series (2007) 2, 141–146 ORIGINAL PAPER 3B-S12-2 © 2007 The Author. Journal compilation © 2007 Blackwell Publishing Ltd. Blackwell Publishing Ltd Regulatory oversight of cellular therapies A. Farrugia Office of Devices, Blood and Tissues, Therapeutic Goods Administration, PO Box100, Woden, ACT 2603, Australia The agencies charged with the oversight of the mainstream therapeutics industry are challenged by the need to develop appropriate models for the regulation of emerging biological therapies. While banked tissue is subject to some level of alignment to manufacturing standards such as Good Manufacturing Practices, many of the traditional concepts for assuring safety, quality and efficacy have not been applied to most of the products derived from human cells and tissues. With the products of higher level manipulation such as tissue engineering and cell vaccines, a fit into the paradigm for regulating devices and medicines has presented difficulties for the regulator and regulated alike. These products have been viewed as being part of medical practice rather than as the result of mainstream pharmaceutical manufacture. Furthermore, their unique source makes them difficult to assess in traditional regulatory systems based on the tenets of pharmaceutical quality control. These considerations have led the established regulatory agencies of the developed world to develop new regulatory paradigms for the products of transplantation practice. While a number of concerns have driven these developments, the minimization of infectious disease risk remains the paramount driver for introducing these regulatory systems. More than the regulation of medicines and medical devices manufactured in traditional pharmaceutical modes, the regulation of cell and tissue products is intimately linked to areas of public health policy and funding. This places regulators in a challenging position as they attempt to reconcile their roles as independent assessors with the needs of the overall public health framework. The role of therapeutic product regulation in healthcare decision-making Government regulation of the therapeutics industry remains a surprisingly established feature of public healthcare policy. In the face of the predominant deregulatory philosophy underpinning much of Western governmental agendas of the past 30 years, the oversight of the therapeutics sector has been proven to be remarkably resilient and even the occasional thrusts from review processes appear half- hearted and more questioning of detail rather than broad principles [1]. Why this should be is beyond the scope of this review; it is likely due to a combination of various converging factors. Although Western governments have been deregulatory in their approach in recent times, they have also not hesitated to utilize the supposedly independent role of product regulators in managing other pressures such as costs and industry protection. While in most instances regulatory agencies are statutorily separate from the policy and funding areas of government, the distinction between what constitutes ‘policy’ and ‘regulation’ generates a perpetual tension within government. Regulators are government officials, charged, like all their fellow bureaucrats, with the core task of implementing the policy of the government of the day and getting it re-elected. Thus, the evidence-based decision-making that is supposed to underpin the regulator’s brief of assuring the safety, quality and efficacy of therapeutic products has necessarily to be colored by the societal – and hence political – imperatives that manifest when products of significant public interest are under review. That this can occasionally lead to developments that draw public ire on the regulator is generally ignored by the public [2], and now accepted by regulatory agencies as an occupational hazard. Correspondence: Albert Farrugia, Office of Devices, Blood and Tissues, Therapeutic Goods Administration, PO Box 100, Woden, ACT 2603, Australia E-mail: albert.farrugia@health.gov.au