BEBAC   Ing. Helmut Schütz

Highly Variable Drugs

EU-EMEA

On 27 April 2006 a Concept Paper (EMEA/CHMP/EWP/147231/2006) for an Addendum to the European NfG on BA/BE was published (Evaluation of BE of Highly Variable Drugs and Drug Products) by the Committee for Medicinal Products for Human Use (CHMP).

Discussion points are:

It is proposed to complement the current Note for Guidance on the Investigation of BA/BE (CHMP/EWP/QWP/1401/98) with an addendum addressing the issue of highly variable drugs and drug products (HVDP).

It is anticipated that a draft CHMP document may be released 12 months after adoption of the Concept Paper. It will be later released for 6 months of external consultation and finalised within 3 months.


Update

In October 2007 the document was removed from EMEA’s site. At the guideline page this quote is given:
Deleted. This topic will be addressed in the revision of the note for guidance on the investigation of bioavailability and bioequivalence (CHMP/EWP/200943/07)

A copy of the Concept Paper ( 36kB PDF) is available from our site for informational purposes only.