Brandwood Biomedical Newsletter June 2010
Friday, June 18, 2010 at 1:09PM New Australian IVD Regulations commence in 10 days
The new TGA Regulations for IVDs are only days away. This is a radical change to the regulation of IVDs in Australia which will have far reaching effects on existing and new suppliers looking to market their diagnostics in Australia. It is vital to understand the changes and carefully plan how your company will work towards meeting all the requirements well within the 4 year transition period.
For a detailed description of the new regulatory regime, read Senior Consultant Paul Cohen’s article recently published in Australian Journal of Medical Science:
Brandwood Biomedical can provide all of the information and resources you require for your compliance, ensuring that all your IVD products conform to the new Regulatory Framework and may continue to be legally supplied in Australia.
Contact us for a free, no obligation initial consultation on what needs to be done and how we can help.
Singapore extends deadline for implementation of new medical device regulations
The next phase of implementation of the new Singaporean medical device regulations (based heavily on GHTF) is not far away, with the deadline for implementation of several new requirements and prohibitions pushed back to August 1.
Mandatory registration of all medical devices commenced from May 1, requiring all registration applications to be submitted in the ASEAN CSDT format (similar to the GHTF’s STED) and full fees to be paid for registration.
Phase 3b of the implementation process will commence from August 1 and will require all manufacturers, importers and licensers dealing with medical devices of all risk classes to hold a Dealer’s License. The supply of Class C and D (equivalent to TGA/European IIb, III and AIMD) devices which are not on the transition list must be registered (unless the device is supplied through the “Authorisation Routes”). The transition list includes Class C and D devices for which pre-market applications were submitted before 30 April 2010.
In addition from 1 August 2011, Class A and B devices must be registered or have an exemption to be supplied.
Annual retention fees will come into place in August 2011 for Class C and D devices, and August 2012 for Class A and B devices (EC/TGA Class I and IIa). Other fees such as change of registrant fee will apply from August this year.
With a direct presence in Singapore and a detailed knowledge of the local requirements, we can help. Want to learn more about preparing to enter the Singapore market? Contact us to talk.
Brandwood Biomedical was delighted to have been associated with a very successful 2010 AusMedTech conference held on 1st and 2nd June was a great success achieving the highest attendance to date. The conference sessions were presented by national and international industry speakers and experts in their respective fields.
A recurring theme during the conference was the challenges of entering overseas markets, with particular focus on the USA and on the opportunities offered emerging markets in Asia and particularly China. For the traditional US markets, apart from the regulatory hurdles, the recent implications of healthcare reform, and the perceived difficulties in raising funds in the U.S as a foreign company, it always came back to the timing of U.S market entry as the key to successfully adding value to the product and product strategy. Timing is everything in China too, with rapid expansion of the Chinese Healthcare system and associated growth in both public and private sector markets. At the same time recent regulatory reforms undoubtedly make China one of the world’s most challenging regulatory systems.
The recent Health Technology Assessment review continues to attract attention in Australia. A key objective of the HTA Review is to address the regulatory burden on business that results from HTA processes, to ensure that those processes are efficient, measured and proportionate. The HTA Review is to identify opportunities for reform of the processes that may be poorly designed, duplicated or unnecessary, imposing unwarranted costs and complexity on business and discouraging innovation. A lively session with presentations from Warren Bingham (Given Imaging), Sue O’Malley (Medical Intelligence) and TGA’s Brian Richards highlighted the importance of planning clinical evaluations to meet Cost Effectiveness outcomes and the radical changes in the system as a result of the recent review including streamlined and concurrent reviews by different bodies for the same product.
TGA releases Guidelines for Medical Devices – ARGMD
The Therapeutic Goods Administration has recently published a comprehensive range of free regulatory guidelines for medical devices in Australia – the Australian Regulatory Guidelines for Medical Devices (ARGMD). The guidelines now provide in one place all TGA guidance on regulatory requirements for medical devices. The guidelines have been developed with input from the Australian medical devices industry. The document is to be used for guidance only and supports the legislation provided in the Therapeutic Goods (Medical Devices) Regulations 2002, Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990. The document can be accessed here.
Bayesian Statistics – cutting clinical trial size, cost and time to market
On the 5th of February 2010 the FDA issued a new guidance document "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials". Use of Bayesian Statistics in clinical trials can achieve outcomes with significantly fewer patients and thus save cost and time.
The FDA has issued this guidance because, under some circumstances, Bayesian methods provide a less burdensome (i.e. smaller, faster and more cost effective) means of appropriate evaluation of a clinical trial. This is a significant opportunity - offering the possibility of real savings in time and expense.
For the technically oriented: FDA has adopted an appropriately measured and cautious approach to the introduction of Bayesian methods. This approach does not abandon frequentist analysis (nor should it, since the agency is legimately concerned with the integrity of the regulatory process). Considerations of type I and type II error rates is still required. Neither has the agency agreed to accept prior information based on subjective opinion (however expert).
The main efficiencies will be garnered through the integration of objective prior information from high-quality clinical studies. The process will require substantially more investment in statistical analysis during the design and planning stage, but will reward that investment through substantial down-stream cost savings. It also calls for input from statisticians skilled in Bayesian methods.
Our Clinical Trials Affiliate DevDx Clinical employs some of Australia’s most experienced Biostatisticans with direct and specific expertise in Bayesian statistics and trial design. Visit www.devdxclinical.com to see how we can help you save costs and shorten time to market through this new opportunity.
The 2010 ARCS Congress this year saw a range of topical and interactive workshops and sessions, with DevDx Clinical’s session on Theranostics attracting a lot of attention. Theranostics refers to molecular diagnostic tests and targeted therapeutics in an interdependent, collaborative manner with the goals of personalising treatment by targeting therapy to an individual’s specific disease subtype and genetic profile. The session was chaired by Arthur Brandwood with main speakers Mervyn Thomas and DevDx Managing Director Paul Cohen. The session discussed the challenges involved in regulation, clinical trial management and statistical analysis of theranostic and diagnostic products.
Are you interested in learning more about personalised medicine? Contact us for more information. Senior consultant Paul Cohen has recently had a relevant article published in Australasian Biotechnology.
Personalised Medicine – Navigating Dx/Rx Co- development (published in Australasian Biotechnology, AusBioTech).