prequalification project drs. jan welink. * note to applicants on the choice of comparator products...
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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)
Reference Test
Pharmaceutical EquivalentProducts
Possible Differences
Drug particle size, ..
Excipients
Manufacturing process
Equipment
Site of manufacture
Batch size ….
Documented Bioequivalence= Therapeutic Equivalence
(Note: Generally, same dissolution specifications)
acceptance criteria: comparative rate and extent of absorption
pharmaceutical equivalence
method: in principle comparative pharmacokinetics (AUC, Cmax)
90% CI 80 - 125%
Bulgaria
Austria
France
Latvia
Poland
Belgium
Germany
Liechtenstein
Portugal
Cyprus
Greece
Lithuania
Slovak Republic
Czech Republic
Hungary
Luxemburg
Slovenia
Denmark
Iceland
Malta
Spain
Estonia
Ireland
The Netherlands
Sweden
Finland
Italy
Norway
United Kingdom
Romania
application
application
application
application
application application
application
application
-national
-MRP
-DC
-centralised
applicationWHO
submission of a complete dossier
- bio-study
- biowaiver
approval of RSA
RMS = applicant
Approval of RSA
submission application
comparator outdated??
dossier other concerns
well established use!!