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WHOPAR Guidance for Applicants
(2004; 140 pages)
Table of Contents
View the documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
View the documentAppendix 1 - Characteristics of WHOPAR Parts
View the documentAppendix 2 - Documentation to submit together with the initial submission
Open this folder and view contentsAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
View the documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

Guidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004

1. Purpose of Guidance

To provide background information on the WHO Public Assessment Report (WHOPAR) and to provide detailed guidance to Applicants (Manufacturers) on the documentation required for the WHOPAR as part of the submission of a product dossier to WHO for assessment under the WHO Prequalification Project1.

1http://mednet3.who.int/prequal/main.htm

Note: This guidance should be seen in addition to the existing submission requirements as published on the website of the Prequalification Project. It addresses only those requirements related to documentation necessary in support of a WHOPAR.


2. WHO Public Assessment Report

The purpose of the WHOPAR is to provide all interested parties with transparent access to information on the procedure followed for the assessment of a finished pharmaceutical product (FPP) for possible inclusion in the "List of prequalified products and manufacturers". In addition, the WHOPAR aims to provide relevant information on the product's quality, safety and efficacy. Also the inspection status will be reflected in the WHOPAR. Publication of WHOPARs is based on Resolution WHA57.142 of 22 May 2004 which requests the Director General of WHO under point 3.(4):

"to ensure that the prequalification review process and the results of inspection and assessment reports of the listed products, aside from proprietary and confidential information, are publicly available".


WHOPARs are published on the WHO Prequalification website3.

2www.who.int/gb/ebwha/pdffiles/WHA57/A57R14-en.pdf
3http://mednet3.who.int/prequal/PAR.htm


The structure and format of the WHOPAR are adapted from the European Public Assessment Report (EPAR)4 as published by the European Medicines Evaluation Agency (EMEA)5 to best serve the requirements of the WHO Prequalification procedure.

4www.emea.eu.int/index/indexh1.htm
5www.emea.eu.int/


The development of a WHOPAR will follow the steps set forth below:

2.1 Procedure

Step 1. Applicant (Manufacturer) submits documents required for the WHOPAR as part of the initial submission to WHO;

Step 2. WHO compiles the draft WHOPAR when the assessment is completed;

Step 3. WHO sends 6 the draft WHOPAR to the applicant for comments;

Step 4. Applicant reviews and comments (annotates) the relevant Parts of the draft WHOPAR, especially to ensure that the WHOPAR does not contain proprietary and or confidential information;

Step 5. Applicant returns 6 annotated draft WHOPAR to WHO;

Step 6. WHO reviews annotations and finalizes WHOPAR (steps 3 to 5 may be repeated in case any item needs further clarification);

Step 7. If the product, as produced at the specified manufacturing site(s), has been found to meet the recommended standards, WHO accepts the product for inclusion in the 'List of prequalified products and manufacturers' 7 and publishes the WHOPAR; the applicant is informed accordingly.

6 Surface mail may be used, however to ensure timely publication of the WHOPAR and inclusion of the product in the 'List of prequalified products and manufacturers', email is the preferred way of communication.

7http://mednet3.who.int/prequal/hiv/hivsuppliers.pdf


3. WHOPAR structure

The WHOPAR consists of 8 Parts:

1. Abstract
2. All Accepted Presentations
3. All Product Information Leaflets in English
4. All Summaries of Product Characteristics in English
5. All Labelling in English
6. Discussion
7. Steps taken for Prequalification
8. Steps taken following Prequalification


The characteristics of the above mentioned WHOPAR Parts are described in Appendix 1. Applicant (Manufacturer) contribute relevant documentation for Parts 3, 4 and 5 as well as, if required, a Summary of Product Safety and Efficacy to be included in Part 6.

4. Requirements for submission

Required documentation as described in Appendix 2, is to be submitted as part of the initial submission. Failure to include any of the required documentation may result in rejection of the application.

The "Procedure for Assessing the Acceptability, in principle, of Pharmaceutical Products for Purchase by United Nations Agencies" 8 under paragraph 2.2 "Submission of dossiers" identifies two types of submissions: for innovator products and for multisource (generic) products.

8http://mednet3.who.int/prequal/documents/ppdoc2.pdf


4.1 Innovator products

Detailed requirements for submission are provided on the website of the Prequalification Project 9. With respect to the submission of documents in support of a WHOPAR one of two approaches will apply depending on the availability of publicly accessible information about the evaluation and the evaluation process of the product e.g. in a public assessment report as made available by a Drug Regulatory Authority in the ICH regions or associated countries 10.

9http://mednet3.who.int/prequal/dossiers.htm#3
10 At the time of issue of this guidance public assessment reports are available from the EMEA (see footnote 4) and FDA at Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm


1. A public assessment report as referred to is available: The WHOPAR will essentially refer to the public assessment report as published by the relevant Drug Regulatory Authority. Applicant (Manufacturer) should provide:

• Package Leaflet (Part 3), Summary of Product Characteristics (Part 4) and Labelling (Part 5) in accordance with the format described in Appendix 3.

• On a voluntarily basis, a Summary of Product Safety and Efficacy of the FPP as contribution to the Discussion (Part 6) (see Appendix 4). Parts 7 and 8 will reflect WHO's interactions with the applicant.


2. No public assessment report as referred to above is available11: The Applicant (Manufacturer) should provide:

• Package Leaflet (Part 3), Summary of Product Characteristics (Part 4) and Labelling (Part 5) in accordance with the format described in Appendix 3.

• Summary of Product Safety and Efficacy of the FPP as contribution to the Discussion (Part 6) (see Appendix 4).


Part 7 and 8 will reflect WHO's interactions with the applicant.

11 A confidential Assessment Report may be available from a National Drug Regulatory Authority in the ICH regions and associated countries; if available, the Applicant (Manufacturer) may enclose this report with the submission or assessors will request a copy of this report from the relevant Drug Regulatory Authority to assist in the evaluation for Pre Qualification.


4.2 Multisource (generic) products

Detailed requirements for the submission are provided on the website of the Prequalification Project 12. With respect to the submission of documents in support of a WHOPAR one of two approaches will apply depending on the availability of an innovator or comparator/reference product:

12http://mednet3.who.int/prequal/dossiers.htm#2


1. An innovator or comparator/reference product is available: The Applicant (Manufacturer) should provide:

• Package Leaflet (Part 3), Summary of Product Characteristics (Part 4) and Labelling (Part 5) in accordance with format described in Appendix 3. The text should as much as possible follow same documents for the innovator product. Especially the indication and safety profile should be the same as approved for the innovator product or for the comparator/reference product in case the innovator product is no longer on the market.


For the Discussion, a Summary on Product Safety and Efficacy is not considered necessary, as relevant information on product safety and efficacy is generally available for this type of products.

2. An innovator or comparator/reference product is not available e.g. new combinations of existing products like fixed dose combinations or traditionally used multisource products such as the artemisinines. The Applicant (Manufacturer) should provide:

• Package Leaflet (Part 3), Summary of Product Characteristics (Part 4) and Labelling (Part 5) in accordance with the format described in Appendix 3.

• Summary of Product Safety and Efficacy of the Finished Pharmaceutical Product as contribution to the Discussion (Part 6) (see Appendix 4);

• Bibliographic submission containing all relevant scientific literature, in case of FDCs including evidence on the safety and efficacy of the equivalent combination of single API products, original clinical research (if carried out) and other documentation in support of the information provided in the Package Leaflet, Summary of Product Characteristics and Summary on Safety and Efficacy in the Discussion (see Appendix 2).


5. Additional Information

Additional information on this procedure can be obtained by email from Dr M. Stahl at stahlm@who.int.

 

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