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