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)

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%

CPH

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comparator outdated??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!!

Thank you for your attention