Call for drug and devices approval agency cooperation to meet demand for new category of synergistic drug/ device technologies

Sweden 7-9 October – regulators have called for even greater cooperation between the drug and devices regulatory systems at the first ever joint session between the medicines and devices arms of TOPRA (The Organisation for People in Regulatory Affairs) at its Annual Meeting, Stockholm 6-9 October 2009.

“Emerging technologies are bringing a new category of product where 1 + 1 = 3. These drug/ device combinations with a synergistic effect demand a cooperative regulatory approach,” explained Ann O’Connor, director, Human Products Authorisation and Registration, Irish Medicines Board (IMB) Ireland.

“Historically there was certain rivalry between drug and device approval agencies and we saw product development overtaking changes in the regulatory systems. Now the agencies are working hard to bring the system up-to-speed to ensure that newer technologies and products get safely to market to benefit patients at the earliest opportunity,”

“Of the five agencies in the EMEA actively providing drug consultations in devices – Netherlands, UK, Ireland, Sweden and Germany – there is promising consistency. We need more of this collaborative thinking,” O’Connor concludes.

Key discussion drivers at the Medical Devices Symposium were definitions, particularly around combination products, as industry and agencies reviewed the implications of new EU procedures and guidance, MEDDEV 2.1/3 rev 3. Effective from March 2010, it covers borderline products, drug delivery and medical devices incorporating ancillary medicinal substances, reflecting emerging technologies.

Other highlights were guidance on how to effectively navigate the regulatory system for devices and combination products, with the key outtake being the need for substantive evidence to support definitions, and the need to put in order evidence to meet the new requirements for devices set out in MEDDEV 2.1/3 rev 3.

Dr Matthias Neumann of the German Health Federation warned: “If you are not currently doing your job with an eye to the new regulations, there is a chance you will be out of a job in March 2010!”

In the concluding session, What Does the Future Hold? Lennart Philipson, Director Medical Devices, MPA, Sweden, reported that a recent unexpected EU Commission public consultation could herald a proposal for significant change in device approvals as early as 2010.

There was also discussion around quality systems and not pre-market approval remaining the key. Should the way to find out how a thing works be by use? Should regulators focus more on organised post marketing surveillance, not pre-market approval and not using EMEA? This would inevitably be the prelude to some sort of pre-market approval system…

Is the challenge with medical devices the mix of sciences, new technology such as nano technology, where you do not have a precedent to see what might happen and where risk cannot be adequately assessed by pre-launch testing? Therefore, should thinking move away from the precautionary principle to more sophisticated risk-benefit analysis and increased reliance on detailed, informed consent and post-market experience.

Concluded Lennart Philipson: “My personal view is that there is a need for a central structure, but I am not convinced it is the EMEA, it currently does not have the expertise.”

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