MeddiQuest Limited - Regulatory Affairs Management

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Combination Products

U.S.

There are three regulatory regiemes: drugs, devices and biologics. Some products which fall into one category are still regulated by a Center normally responsible for another because FDA recognize that is where the expertise necessary to assess the submission exists. In many instances there are inter-Center agreements that formalize these arrangements and can form precidents for new types of products.

Under the Food and Drug Administration Modernization Act, FDAMA, pre-clinical/submission meetings have become more common and generally an inter-Center agreement can be reached for a particular product here, if not before.

The normal avenues of petition and appeal, and/or use of the Onbudsman, are open to the manufacturer to challenge any agreement by FDA Centers.

The advice of Regulatory Affairs professionals as well as Legal Regulatory Counsel, is strongly advised.

E.U.

There are two alternative regulatory regiemes: Medicines and Devices. Under EU Law, the Medicines Authority of Member State has pre-eminence over the Device Agency. If the Medicines Authority does not wish to regulate the product (or some part of it) as a Medicine, then by default the Devices Agency will regulate the whole (or the remainder as a device). The Device Agency may then decide under which of the EU Directives the product will be regulated.

It is fair to say that the functioning of Device Agencies is generally simpler and quicker then Medicines Agencies - Devices after all fall under New Approach Directives, while the majority of Medicines legislation pre-dates the new- approach. Consequently, there are real advantages in having the product or as much of it as possible regulated as a device.

The Manufacturer needs to form a very clear view of whether their product (or its constituent parts) should be regulated as a medicine or a device and under which directive. The Manufacturer will then apply to the Agency who they think should regulate it, argue their case in terms of law, precident and scientific rationale. This is a complicated process and should not be entered into lightly. Having received a determination from the Agency in the manufacturer's home EU country, it is extreemly likely, although not inevitable, that this will be concurred with throughout the E.U.

MeddiQuest

Resolving issues around combination products is an essential interest area for us. Ian and Neil work together on these issues, because of their different backgrounds and contacts they can explore all the alternatives and highlight the key issues and criteria upon which a determination will be based.

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Uploaded April 21, 2006
Last updated April 21, 2006
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX