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The WHO Prequalification of Medicines Programme Dossier Assessment. Rutendo Kuwana Technical Officer Prequalification of Medicines Program WHO. The PQ Process Flow. Its simple, straight forward and designed for complete product review – just like a Stringent Regulatory Authority. - PowerPoint PPT Presentation
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EMP TBS, 5 November 2010
The WHO Prequalification of Medicines ProgrammeDossier Assessment
Rutendo Kuwana Technical Officer
Prequalification of Medicines ProgramWHO
EMP TBS, 5 November 2010
The PQ Process Flow
Its simple, straight forward and designed for complete product review – just like a
Stringent Regulatory Authority
EMP TBS, 5 November 2010
Dossier for FPP pre-qualification
ScreeningApplicant
Quality Part of Dossier
APIFPP
Efficacy/Safety Part of Dossier
BiowaiversBioequivalence studies
Clinical trials
GMP
API manufacturing sitesFPP manufacturing sitesClinical research sites.
Review of GMP Certification,Inspection reports,
Site Master Files (SMF).
Informationrequested
Applicant
Dossier accepted for assessment
Assessment
Assessment Assessment
APIMF
Accepted
Accepted Accepted Accepted
Informationrequested
Applicant
Manufacturers
Inspection
Corrective and preventive actions
Final decision on prequalification
Listing on WHO websiteRequalification
(5 years after listing)Variations
ComplaintsRandom sampling
Informationrequested
Informationrequested
APIMFholder
Informationrequested
Optional
EMP TBS, 5 November 20104
Dossier Screening Conclusion
Accepted for assessment Accepted under certain conditionsNot acceptable. Rejected
Applicant still receives extensive comments on any deficiencies
EMP TBS, 5 November 20105
Use of Biopharmaceutics Classification System
Requirement for in vivo bioequivalence testing may be waived under certain conditions– Solubility of drug substance– Permeability of drug substance– Uncomplicated drug substance– Immediate-release dosage form– Acceptable dissolution characteristics of dosage form
EMP TBS, 5 November 20106
Application of BCS in PQP
PQP has reviewed existing information on the bioavailability and dissolution data of the invited medicines
Identified some drug substances as eligible for a BCS-based biowaiver application - either monocomponent or fixed-dose combination (FDC) products
Monocomponent or FDC products containing other drug substances must be supported with in vivo BE data
EMP TBS, 5 November 20107
What's New in PQP?• New guidelines for
submitting new dossiers• Clarifications on
guidelines for submitting Variations
• Requalification of medicines
• Prequalification of APIs• Joint assessments
EMP TBS, 5 November 20108
The new draft generic quality guideline:Key Features
Common Technical Document (CTD) structure – Electronic summary: Pharmaceutical Quality Information
Form (PQIF) replaced by Quality Overall Summary (QOS)) Elaboration of current requirements Updated requirements
– Some key reduced requirements
EMP TBS, 5 November 20109
PQ Dossier Variation GuidanceThree categories of variations, according to potential
impact to quality of product and current timelines we aim to achieve (achieved already)
• Notification - no or minimal impact: 30 days
• Minor change - potential minor impact: 60 days
• Major change - potential major impact: 60 days
EMP TBS, 5 November 201010
Requalification
Procedure for prequalification of pharmaceutical products requires holders of WHO-prequalified
products to submit a quality review after five years from the date of prequalification of the product, or when requested to do so by PQP (whichever date is
earlier)
EMP TBS, 5 November 201011
Upcoming Enhancers
• Dossiers to be submitted in CTD format• Increased access to assessors for applicant queries –
guideline and procedure for meetings/contacts with applicants under development
• Publish list of prequalified APIs and their specific attributes
• Publish prevailing timelines for key processes• Share with stakeholders relevant information about
prequalified products