Prequalification project Drs. Jan Welink. * Note to applicants on the choice of comparator products for the prequalification.

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Presentation transcript:

Prequalification project Drs. Jan Welink

* 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)

ReferenceTest Pharmaceutical Equivalent Products 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, C max ) 90% CI %

CPH

Bulgaria Romania

application - national - MRP - DC - centralised

application WHO submission of a complete dossier - bio-study - biowaiver approval of RSA RMS = applicant

Approval of RSA submission application comparatoroutdated?? dossier other concerns well established use!!

Thank you for your attention

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