Transcript Generic Applications in the New Decentralised Procedure

Prequalification project
Drs. Jan Welink
http://apps.who.int/prequal/
* Note to applicants on the choice of comparator
products for the prequalification project
* Guideline on generics
- Annex 7 (Multisource (generic) pharm. products:
guidelines on registration requirements to establish
interchangeability)
- Annex 11 (Guidance on the selection of comparator
pharm. products for equivalence assessment of
interchangeable multisource (generic) products)
Pharmaceutical Equivalent
Products
Reference
Test
Possible Differences
Drug particle size, ..
Excipients
Manufacturing process
Equipment
Site of manufacture
Batch size ….
Documented Bioequivalence
= Therapeutic Equivalence
(Note: Generally, same dissolution specifications)
pharmaceutical equivalence
method: in principle comparative pharmacokinetics
(AUC, Cmax)
acceptance criteria: comparative rate and extent
of absorption
90% CI 80 - 125%
CPH
Bulgaria
Romania
application
application
- national
application
application
- MRP
application
application
- DC
- centralised
application
application
application
WHO
RMS = applicant
submission of a complete dossier
- bio-study
- biowaiver
approval of RSA
Approval of RSA
submission application
dossier
other concerns
comparator
outdated??
well established use!!
Thank you for your attention