1. The WHO Prequalification of Medicines Programme Dossier Assessment
Rutendo Kuwana
Technical Officer
Prequalification of Medicines Program
WHO

2. The PQ Process Flow
Its simple, straight forward and designed for complete product review – just like a Stringent Regulatory Authority

3. Dossier for FPP pre-qualification
Screening
Applicant
Quality Part of Dossier
API
FPP
Efficacy/Safety Part of Dossier
Biowaivers
Bioequivalence studies
Clinical trials
GMP
API manufacturing sites
FPP manufacturing sites
Clinical research sites.
Review of GMP Certification,
Inspection reports,
Site Master Files (SMF).
Information
requested
Dossier accepted for assessment
Assessment
APIMF
Accepted
Manufacturers
Inspection
Corrective and
preventive actions
Final decision on prequalification
Listing on WHO website
Requalification
(5 years after listing)
Variations
Complaints
Random sampling
holder
Optional

4. Dossier Screening Conclusion
Accepted for assessment
Accepted under certain conditions
Not acceptable.
Rejected
Applicant still receives extensive comments on any deficiencies
EMP TBS, 5 November 2010

5. 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 2010

6. 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 2010

7. 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 2010

8. 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 2010

9. PQ Dossier Variation Guidance
Three 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 2010

10. 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 2010

11. 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
EMP TBS, 5 November 2010