BEBAC   Ing. Helmut Schütz

EU – EMA

Draft guideline on modified release dosage forms

On 15 Mar 2013 EMA’s Quality Working Party (QWP) published the drafted guideline (dated 21 February 2013) for a six-month public consultation period (i.e., until 15 September 2013).

The primary purpose of this guideline is to define the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified release and transdermal dosage forms in man and to set out general principles for designing, con­ducting and evaluating such studies. The revision of the Note for Guidance on the Inves­ti­gation of Bioavailability and Bioequivalence (EWP/QWP/1401/98) generated the necessity of consequential adjustments. Furthermore the guideline provides updated require­ments for transdermal drug delivery systems (TDDS) and addresses recommen­dations for specific modified release formulations, e.g. for intramuscular / subcutaneous depot formulations.

Comments should be provided using this template and sent to PKWPsecretariat@ema.europa.eu.


Update

The final Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) was adopted by the CHMP on 20 November 2014, published on 27 November 2014, and will be effective with 1 June 2015.

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