Frequently asked questions (2024)

Section navigation

© Credits

A product profile is a written document describing the characteristics of a health product. They are used in planning research and development and can also frame the description of a product for regulatory purposes. There are two broad categories (without standard nomenclature) that have be defined following a review of more than 200 published documents:

• Preferred Product Characteristics (PPCs) are prospective, strategic documents describing an ideal product class often at the early stage of development or seeking to stimulate innovation in a new area. For WHO the preferred term here is Preferred Product Characteristics (PPC) but other agencies use similar terms including Ideal Product Profile, Intervention Product Profile or Target Candidate Profile (among others).
• Target Product Profiles (TPPs) are used when a pipeline develops, and more specific targets and minimum performance characteristics are able to be described with a much narrower specific description.
• Target Regimen profiles (TRP) Are used when several drugs would be used in combination regimen.

All variations of product profile are captured in the Directory.

Recent pandemics have highlighted the urgent need for centralized information at global level to guide and improve coordination of efforts to develop new health products for neglected diseases and populations. The initial concept for this resource is contained in the TDR report, Health Product Research and Development Fund: a Proposal for Financing and Operation (2016). Specifically, the Directory:

• Provides a repository for existing health product profiles.
• Introduces harmonization and standardization in the description of health product profiles.
• Enables a high-level landscape analysis of R&D activity related to these product profiles
• Emphasizes access, equity and affordability as integral parts of the innovation process that need to be considered at all stages, not just after a product is developed.

A product profile authored by WHO indicates that the organization determines there is a significant unmet health need for the product in question, and the product profile preferences promote the development of products with high public health impact and suitable for use in low to middle-income countries.

WHO Target Product Profiles (TPPs) are intended to support the development of missing health products and are needs based and focused on public health priorities. WHO TPPs emphasize access, equity and affordability as integral parts of the innovation process that need to be considered at all stages, not just after a product is developed.

A WHO TPP is intended as a strategic reference document for comparison and transparency on alignment between 1) WHO’s preferences for product development in a given area and 2) the product or development programme specific TPP used by the industry or funding entity. The WHO TPP document should inform product developers, regulatory agencies, procurement agencies and funders on R&D and public health priorities. It is intended to facilitate the most expeditious development of products addressing the greatest and most urgent public health need.

Where WHO has identified a priority need for a product class, but the stage of development is early, some documents will use the term Preferred Product Characteristics (PPCs) focusing on providing strategic guidance and higher-level considerations (for example 2nd generation malaria vaccines).

WHO Preferred Product Characteristics (PPCs) describe WHO preferences for parameters. In particular, these include its indications, target groups, possible intervention strategies, and features of clinical data desired related to safety and efficacy.

What are the inclusion criteria for a product profile to be listed in the Directory?

The Directory does NOT aim to cover all health products. Instead it describes profiles of health products for which there is currently no market or limited incentive for research and development. These include: poverty-related neglected diseases, diseases identified as having the potential to cause pandemics (e.g. Ebola), new products to combat anti-microbial resistance, products with a focus on addressing health issues in low- and middle-income countries, and products prioritized for global action by the World Health Organization and are clearly marked as authored by WHO.

The Directory also lists those product profiles authored by Product Development Partnerships, commercial companies and other organizations that share the same inclusion criteria listed above. These are labelled non-WHO profiles.

What can I use the Health Product Directory for?

The Directory allows a user to search by disease, product type, date of creation, author (who produced the profile) and status (whether the profile is still active or has been archived as a historical record.) The Directory provides a url or contact email to enable the user to access, where available, the full document with more detailed information on the profile.

How do I submit a new profile?

Any organization that meets the inclusion criteria can submit a summary of their product profile via the online form. Please note this must include a url linking to the publicly accessible full document of the product profile or a contact email where requests for further information can be sent. Where a collaboration has generated a product profile a lead author of the profile must be selected.

The inclusion criteria are: health product profiles for which there is no market or limited incentive for research and development. This includes: the poverty related neglected diseases, the diseases identified as having the potential to cause pandemics (e.g. Ebola), new products to combat anti-microbial resistance and those products with a focus on addressing health issues in low- and middle-income countries.

Submission Process

Either enter text from the drop-down menu or enter text free style as appropriate.

The submission will be reviewed to ensure the fields are correctly filled in and that contact details or a url to the public document are supplied. IMPORTANT: If an email address is supplied in the url field that email address will be publicly available for users to contact it to request more details on the product profile. .

Table 1. below provides a brief description of the health product characteristics required to list your profile in the Directory. Please note not all characteristics apply to all types of product profile.

Table 1: Description of the health product profile characteristics contained in the Health Product Profile Directory.

Please note the Directory is moderated so when your profile is submitted it will not be immediately live in the Directory. The content will be reviewed to ensure the data in the fields correspond with the definition above. Following review, it will be published within 3-4 working days. No profile will be published without containing either contact details as an email or a url to the public document. Please note the disclaimer below which states that inclusion in the directory of non-WHO authored profiles does NOT imply any endorsem*nt or recommendation of that product profile by the World Health Organization.

How do I update an existing profile?

It is important that the product profiles are correctly labelled as either Active – the information is still considered up to date or Archived – the product profile is no longer active.

If a product profile you have responsibility for is updated submit the new profile via the submission form and clearly indicate which product profile that exists in the Directory this replaces. During review the original profile that has now been updated will have its status changed to Archive.

The Product Profile Directory will automatically default the status of a profile to Archive after 5 years from its publication date. If you have reviewed the product profile and deemed it still relevant and wish for it to be retained in Active status please email pp-directory@who.int

How do I use the Directory?

You can search/filter the Directory by any or all of the following criteria: disease, year (of creation), product type, status (whether the profile is still active or has been archived as a historical record), and author (who produced the profile). See illustration below.

How do I view my search results?

There are two options:

1. View your results directly on the screen

2. Download your search results to an excel file by scrolling to the bottom of the list and clicking on the blue button. See illustration below.

Contact details

For any queries regarding the Product Profile Directory please email:

Disclaimer – inclusion in the directory of non-WHO authored profiles does NOT imply any endorsem*nt by the World Health Organization.

Copyright © World Health Organization Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGOlicence (CC BY-NCSA 3.0 IGO; https://creativecommons.org/licenses/bync-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Target Product Profile Directory DD/MM/YYY. Geneva: World Health Organization; Licence: CC BY- NC-SA 3.0 IGO. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third party-owned component in the work rests solely with the user. •

General Disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use.

Suggested citation:WHO Health Product Profile Directory DD/MM/YYY. Geneva: World Health Organization; Licence: CC BY- NC-SA 3.0 IGO.