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EC inhaled drug guidance needs attention

17-May-2004

The European Commission is updating its recommendations for products delivered by inhalation or intranasally, saying these no longer reflect the realities in the marketplace for these products.

The agency said the move will make it easier for industry to adhere to the regulatory requirements for these types of products, which are particularly complex as they combine both drugs and devices.

The new guidance will update two documents - one covering dry powder inhalers from 1998 and other for metered dose inhalers from 2002. These have no provision for products delivered intranasally, by nebuliser or the new soft-mist hand-held nebuliser devices.

 

Level playing field for regulators

 

The Commission said that the guidance would also be valuable for regulatory agencies, which will be able to use it to give consistent appraisals of new production applications.

 

"Due to the complexity of these products, it is difficult to ensure consistency among products and among assessments conducted," it said in a statement.

 

The EC has called on the assistance of Canada's regulatory body, which has already worked on a draft broad-ranging guidance document for inhaled and intranasal products. The new guidance should be published in initial form before the end of the year, and will as usual go out for a six-month consultation period.

 

The process will also involve the input of the European Pharmacopoeia's Inhalanda working group, which is currently exploring the possibility of developing a standardised testing methodology for the determination of standard particle/droplet size and distribution in inhaled and intranasal products.

 

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