Obtaining prequalification of an in vitro diagnostic (IVD) may demand considerable investment, in terms of both financial investment and staff time (to improve production quality and/or to prepare a dossier for submission and deal with any requests for further information from WHO). But benefits may accrue to a manufacturer during and following product prequalification.
Increased technical capacity
The landscape for IVDs is complex: not only with respect to their development and production, but also their regulation. By participating in WHO prequalification for IVDs manufacturers can develop a deeper understanding of how to meet international standards for quality-assured production of IVDs. This can develop through application of WHO's publicly-available guidance relating to IVD prequalification, or when specific guidance is received from WHO during assessment of a product dossier, inspection of its manufacturing site(s) or review of the results of its performance evaluation. Manufacturers also report that one-to-one meetings with WHO assessors, such as those that take place before submission of a product dossier, are particularly helpful. WHO's active participation in development and harmonization of IVD regulation also mean that it can provide considerable guidance to manufacturers seeking to understand and navigate this difficult technical area. In brief, manufacturers involved in WHO prequalification may find that they:
- further develop their human resources for ensuring and managing quality manufacture
- enhance their capacity to ensure quality manufacture across their range of products
- increase or develop new capacity to understand and meet stringent regulatory requirements.
Sales and market access opportunities
Prequalification is used by UN agencies, non-UN donor agencies, procurement agents and some low- and middle-income countries to guide their procurement of IVDs. Gaining prequalification for a product can therefore increase its eligibility for donor-sponsored tenders for IVDs. Procurers mention that as part of their screening of manufacturers, they often check whether a manufacturer has prequalified products in its portfolio since this is generally seen as a positive indicator with respect to the manufacturer's quality standards overall.
In parallel, if they have not yet entered stringently-regulated markets, manufacturers may find that by having participated in WHO prequalification they have become better equipped to do so. Their success in competing for contract manufacture for local markets may also increase.
Improved image or brand
WHO prequalification is a trusted and reputed symbol for safety, quality and efficacy across stakeholders. Manufacturers of prequalified products have reported that their image or product brand has improved following prequalification, and that their employees have welcomed prequalification status.
Additionally, the WHO Collaborative Procedure for Accelerated Registration that has been piloted with prequalified IVDs will offer manufacturers the possibility of getting their products onto markets in countries more quickly.
Also for male circumcision devices....
Much of the above also applies to prequalified male circumcision devices (MCDs) which represents a smaller but nevertheless important area of WHO prequalification activity.
Which manufacturers can participate?
Any manufacturer of an IVD may apply for prequalification of its product(s), provided that the IVD in question is eligible for prequalification.
Information for manufacturers who wish to participate
The key sections of this website for potential applicants who wish to participate in WHO prequalification of IVDs or MCDs, and those already participating in WHO IVD or MCD prequalification are:
- IVDs Under Assessment and MCDs Under Assessment ― summarize what products are currently under assessment
- WHO List of Prequalified IVDs and WHO List of Prequalified MCDs ― giving details of IVDs and MCDs that have been prequalified, including applicant and manufacturing site details
- IVDs Eligible for Prequalification and MCDs Eligibile for Prequalification ― information on the IVDS and MCDs currently eligible for evaluation for prequalification
- Procedures and Fees for IVD Prequalification and Procedures and Fees for MCD Prequalification ― information on prequalification requirements for FPPs and APIs, be this for full assessment or for products that have already received approval from a stringent regulatory authority, as well as application procedures
- Post-prequalification Procedures for IVDs and Post-prequalification Procedures for MCDs ― information on what an applicant must do to maintain prequalification status
- Prequalification Reports ― WHO Public Assessment Reports describe the products that have been prequalified and WHO Public Inspection Reports describe the manufacturing sites that have passed WHO inspection
- Guidance Documents ― three types of guidance are available: WHO prequalification guidance (including sample dossiers); the WHO Technical Specifications Series and the WHO Technical Guidance Series
- Collaborative Procedure for Accelerated Registration ― describing an innovative WHO procedure that offers manufacturers the opportunity to get their products onto markets more quickly
- Support to Manufacturers ― describes the technical advice and specialized technical assistance available to manufacturers to help them work towards prequalification of their IVD or MCD
- Market Information ―with links to reports and sources that contain information (including prices and volume) about who is procuring what
- Emergency Use Listing Procedure and Expert Review Panel for Diagnostics ― describing procedures other than prequalification for assessing products and which can facilitate market entry for manufacturers
- Key Contacts ― the key persons who can be contacted regarding different aspects of medicines prequalification, or collaborative registration or technical assistance.
Before submitting an application for prequalification
New applicants should contact WHO before submitting an application for evaluation of an IVD or MCD. A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification. (It is also recommended that manufacturers who have already submitted products for prequalification request a pre-submission meeting before submitting an additional product for prequalification.) Manufacturers can request a pre-submission meeting by contacting firstname.lastname@example.org. WHO is able to advise on all aspects of a submission, including dossier format and content. A good-quality dossier at submission will increase the likelihood that it pass screening. Moreover, a good-quality dossier is one of the most important determinants of time to prequalification.
Pre-submission meetings are also available to manufacturers who have already submitted products for prequalification.
WHO may also make recommendations regarding organization of technical assistance if it considers that a manufacturer should work on a specific technical issue or problem area before submission of an application.