Frequently Asked Questions (FAQ)

Answers to common questions can be found here. If you still have questions please submit them using the link in the right sidebar.
  • The standards against which WHO evaluates finished pharmaceutical products, active pharmaceutical ingredients and quality control laboratories are based on the principles and practices agreed by the world’s leading regulatory agencies and adopted by the WHO Expert Committee on Specification for Pharmaceutical Preparations.

     

     

  • WHO staff responsible for assessments and inspections are generally recruited from regulatory agencies. They work with regulators from stringent regulatory authorities (SRA) (for example, SRA assessors attend the assessment sessions held in Copenhagen, adn SRA inspectors join WHO inspections as co-inspector) or to ensure that their levels of knowledge and expertise in medicines regulation and pharmaceutical science are maintained. They also work with regulators from low-income countries where the medicines will be used, to ensure that the process and results are understood and trusted by those countries.

    Additionally, the assessment and inspection groups include rotational staff from low-income regulatory agencies. The rotational staff work with WHO prequalification colleagues for several months and then return to their agency. Upon their return home they share the knowledge and experience they have acquired with colleagues and also serve as an ambassador for WHO prequalification.

  • For active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs): Any manufacturer of active pharmaceutical ingredients (APIs) and/or finished pharmaceutical products (FPPs) can express an interest in having its API or FPP products evaluated by WHO, provided those products are eligible for assessment. FPPs eligible for evaluation include both generic and innovator FPPs, and FPPs that contain just one active ingredient or that combine several.

    The following is a simplified overview of the prequalification process for APIs and FPPs.

    1. The manufacturer verifies that the API or FPP that it wants to submit for evaluation for prequalification is included in the relevant Invitation to Manufacturers to Submit an Expression of Interest for Evaluation.
    2. The manufacturer submits an application to WHO in accordance with the prequalification procedure for the product (either API or FPP).
    3. WHO reviews the information submitted for evaluation for prequalification. This review may include a request or requests for additional information. Inspection of the manufacturing site(s), and, if relevant, of the contract research organization that performed a related study, may also be necessary.
    4. If the API or FPP has already been approved by a stringent regulatory authority, the applicant may choose to make a submission for abbreviated assessment.

    For medicines quality control laboratories (QCL): Medicines quality control laboratories (QCLs) that undertake chemical and microbiological (including bacterial endotoxins) testing of medicines are also eligible to apply for prequalification.

    The process for prequalification of QCLs is similar to that for APIs and FPPs, consisting of the following steps:

    1. The QCL consults the Invitation to Manufacturers to Quality Control Laboratories to Submit an Expression of Interest for Prequalification, to verify that it is eligible for prequalification.
    2. The QCL submits an application — which will include a laboratory information file — to WHO, in accordance with the prequalification procedure for QCLs.
    3. WHO reviews the laboratory information file (or quality manual). It may request submission of additional information and it may also stipulate inspection of the QCL.

    Once an API, FPP or QCL has met prequalification requirements it is added to the relevant WHO list.

  • Presubmission

    WHO will contact the manufacturer within one month after receiving a complete presubmission form inviting it to submit a product dossier that meets the requirements of the relevant product performance specification.

    Dossier review and decision

    WHO will contact the manufacturer within one or two months of receiving the product application dossier depending on the number of clarification questions raised by the dossier review team.

    Dossier reviews are carried out once per month.

    • dossiers received on or before 1st Tuesday of any month will be assessed on 4th Tuesday and/or Thursday of that month
    • dossiers submitted after 1st Tuesday of every month will be evaluated 4th Tuesday and/or Thursday of the following month.
  • WHO prequalification of immunization devices is a collaborative effort between WHO, WHO Member States, technical agencies, manufacturers and donors. Its purpose is to ensure the availability of quality, reliable immunization products in order to help safeguard vaccine potency, as well as expand and extend their availability.

    It achieves this by:

    • enforcing and setting quality and performance standards that reflect product end user needs and help shape technologies to meet evolving user requirements
    • providing assurance to national and international procurers that products adhere to the desired standards of quality and safety and meet the performance requirements of low-resource settings
    • helping manufacturers to improve their capacity to meet quality standards for existing products and desirable new technologies
    • adhering to rigorous laboratory testing protocols.
  • The key outputs of WHO prequalification of immunization devices:

    • the catalogue of WHO-prequalified immunization products
    • the list of laboratories that are accredited to test for product compliance with prequalification standards
    • standards for immunization products
    • product verification protocols for the testing and evaluation of products
    • target product profiles that define the desirable characteristics for future innovations
    • guidance for product manufacturers and testing laboratories to carry out field evaluations
    • guidance and resource documents for product users on installation, use and maintenance of prequalified documents
    • reports on post-market product performance feedback
    • guidance for appropriate product selection.
  • WHO collaborates closely with EPI programmes, industry manufacturers, testing laboratories and a range of technical specialist organizations to enableWHO Member States and UN purchasing agencies to procure suitable, reliable products. It:

    • is responsible for developing and maintaining standard operating procedures, product specifications, verification protocols and guidance documents
    • works with the relevant WHO and UNICEF Supply Division departments
    • liaises with the ad-hoc specifications working group and consults with a range of external stakeholders, from manufacturers to academia.
  • WHO prequalification of immunization devices consists of four areas of work:

    • setting standards and norms: WHO uses international standards to evaluate immunization products. If no such standards exist for challenging operating environments, WHO works with industry and partners to define appropriate design criteria. These criteria are codified in product specifications which lay out the functional and performance characteristics required of any product or device to be evaluated for WHO prequalification. Specifications are constantly evolving, informed by feedback on product performance in the operating environment.
    • evaluating products for prequalification: Every product specification is accompanied by verification protocols that outline precisely how products must be tested for compliance with the performance specifications. Dossier reviews take place once per month during which a team of independent evaluators together with the immunization group of the Prequalification Team assess product dossiers recently submitted by manufacturers. Each dossier must include a product test report from a WHO-accredited laboratory. All prequalified products undergo annual review in April of each year. Subsequent to the review, a product may retain its prequalified status or see it withdrawn if product performance and/or required documentation no longer meet WHO standards or requirements.
    • stimulating product innovation: WHO aims to consistently improve the quality and reliability of immunization products. To achieve this, it engages with WHO Member States and manufacturers to understand the evolving needs of product end users and to define desirable future product characteristics that will better satisfy operational and programmatic needs. These characteristics are described in target product profiles. This process also helps to support a healthy and competitive marketplace, as well as stimulate innovation and the development of new technologies for immunization products. WHO also provides guidance for the field-testing of products for which this is a prequalification prerequisite.
    • assessing laboratories’ suitability for product testing-accreditation: A WHO-accredited laboratory is an organization that conforms to international standards or codes of practice. It is able to demonstrate to a competent third-party accreditation body that it meets these criteria. Laboratories may be accredited to test one or several categories of immunization products. They must also be able to carry out one or more of the three types of product verification test: type-examination, independent type testing, or full quality assurance.
  • Any manufacturer of an immunization-related product or device (hereafter, “product”) may apply for prequalification of a product that belongs to a product category that WHO prequalifies. In the first instance, WHO prequalifies products that are offered by the legal manufacturer of the product. Products offered by a reseller may also be considered for prequalification if a formal licensing arrangement exists with the legal manufacturer.

    The full product prequalification procedure consists of three stages for product manufacturers:

    • completion and submission of a presubmission form
    • product dossier evaluation  and product testing
    • annual post-prequalification re-evaluation to ensure a product’s continued compliance with WHO prequalification standards.
  • WHO recuperates the cost of dossier evaluation through fees charged to the manufacturer. Dossier evaluation fees are set per category of immunization products or devices and range between US$ 2000 and US$ 3200 per category, with the exception of coolant packs, for which the application fee is US$ 600.

    Manufacturers whose products are successfully prequalified by WHO will also be charged a fee for the annual product review of each prequalified product. Annual review fees are also set per category of product and range from US$ 1200 to US$ 1600, with the exception of coolant packs, for which the annual review fee is US$ 300.

  • WHO requires a separate and complete product application dossier for each product deemed suitable for evaluation. In addition, a separate dossier is required for each new site at which a product is manufactured.

    The product application dossier must contain:

    • complete details of the manufacturing process
    • documented evidence that the product meets the performance and functional requirements detailed in the relevant performance specification
    • complete manufacturing certification and licencing.

    In addition to the application documentation, manufacturers may be required to test products using one of four laboratory testing procedures and or field-testing; the results of which will be evaluated by PQS.

    Once the appropriate product verification or testing has been completed and included in the product application dossier, the dossier will be accepted for review by WHO and will be distributed to the members of the relevant dossier review team. Each application is reviewed independently by a dossier review team.

  • All areas of WHO prequalification of immunization devices are governed by standard operating procedures that are informed by key external standards and processes:

    • performance specifications and product verification procedures are informed by ISO and other standards
    • laboratory accreditation procedures stipulate the need for laboratories to be ISO/IEC 17025-accreditated by International Laboratory Accreditation Cooperation signatories or other accreditation bodies
    • product field-testing procedures are guided by industry-standard and WHO protocols.
  • Every product or device is prequalified on the basis of a performance specification. This describes the specific environment in which the product will operate and defines the functional requirements that it must fulfil in order to operate successfully in that environment. A performance specification thereby establishes standards of adequate performance.

    Additionally, each performance specification is accompanied by one or more verification protocols which specify the testing procedures that must be used to demonstrate product compliance with the functional requirements and in order to attain prequalification. 

    Every prequalified product is reviewed once annually to ensure that it continues to meet current performance specifications.

    WHO relies on user feedback about equipment performance under field conditions to revise and improve product standards and specifications. 

  • In some specific cases, testing of a product or device in its intended operating environment may also be required to demonstrate that a product meets all prequalification requirements. Field testing is required, for example, for products that include technology not previously used in health programmes in low-resource settings, or that require the creation of a new category of products for prequalification.

    Field testing provides manufacturers with information to further improve product design and it can also help end users to choose products that are best suited to their needs. Field testing is carried out by the product manufacturer with the support of testing laboratories and in accordance with protocols established by WHO. Also essential is the active cooperation of national EPI programme managers and the assistance of technical staff in WHO/UNICEF country and regional offices.

  • This website offers three sources of support for product selection:

    1. The Catalogue of Prequalified Immunization Devices includes details of all prequalified immunization-related products. It also contains comprehensive guidance notes to help purchasers make informed choices. The Catalogue product sheets are updated each time a change occurs with regard to a product, a manufacturer or a laboratory. The Catalogue is published quarterly.
    2. The search and compare tool provides rapid access to basic product details, as well as the opportunity to identify and compare the appropriate products based on the specific challenges and needs of particular operating environments.
    3. Links to interactive product selection tools can help EPI programme managers and technicians select the most appropriate equipment through guided, step-by-step analysis of the operating context, finances, performance needs and any challenges and constraints that their programme faces at its various health service points and vaccine storage centres.

    Once the national EPI programme has identified the appropriate prequalified products these may be ordered:

  • WHO works to ensure the availability of immunization devices that are fit for use by Expanded Programme on Immunization programmes, and to provide manufacturers with a fair basis for tendering products and investing in product development. It:

    • sets and applies standards and norms in the form of product specifications which define the performance, quality and the safety characteristics required for specific operating environments
    • defines the product testing and verification protocols used to determine whether a product meets the specified criteria
    • evaluates whether products meet these performance specifications and are eligible for prequalification by WHO, for use in immunization programmes
    • reviews product performance to determine whether the prequalified status of a product or device can be maintained or should be withdrawn
    • collects product performance feedback from WHO Member States and product manufacturers, and gathers information from product end users about their evolving needs to help stimulate innovation
    • assesses for accreditation the facilities and competencies of laboratories for testing immunization products that are being evaluated for prequalification.
  • WHO accredits laboratories that are qualified to test one or several categories of products seeking prequalification. Accredited laboratories must also be able to carry out at least one of three types of product verification procedures: type-examination, independent type testing, or full quality assurance.

    WHO only accredits laboratories that can demonstrate that they conform to international standards or codes of practice. The laboratory must be able to demonstrate to a competent third-party accreditation body that it meets international requirements.

    At the current time only laboratories accredited by WHO can be selected for testing products for WHO prequalification. In future, WHO plans to open up accreditation to other laboratories that meet WHO accreditation criteria.

  • WHO vaccines prequalification provides advice to UNICEF and other United Nations agencies to help them ensure that the vaccines they procure for use in national immunization programmes are safe, effective and of assured quality and comply with WHO-recommended standards.

    It achieves this by:

    • applying WHO recommendations, as found in WHO quality, safety and efficacy standards for vaccines, made by SAGE and contained in various WHO position papers
    • promoting adherence to good practices, including good manufacturing processes and good clinical practice
    • assessing vaccines according to a prioritization list which reflects Member States demand, programmatic needs and supply security
    • stipulatilng post-prequalification commitments and obligations (e.g. to communicate and investigate vaccine related complaints from the field).
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  • WHO vaccines prequalification collaborates closely with other WHO programmes (e.g. the Expanded Programme on Immunization, Polio Eradication Programme), with procurement agencies (e.g. UNICEF, PAHO Revolving Fund), and with other WHO partners (e.g. the Global Alliance for Vaccines and Immunisation (GAVI), national regulatory authorities and control laboratories, the International Coordinating Group on Vaccines Provision (ICG), vaccine manufacturers and technical specialist organizations). Together with these stakeholders, WHO works to enable WHO Member States to access quality and reliable vaccines that meet their programme needs.

    Vaccines prequalification is also supported by other WHO entities, including the WHO Expert Committee on Biological Standardization that develops and adopts the standards and norms that underpin WHO vaccines prequalification, and by the WHO teams working on safety and vigilance and regulatory system strengthening.

  • The WHO vaccines prequalification process consists of three areas of activity:

    • biennial vaccines priority setting: WHO, in consultation with UNICEF and the PAHO Revolving Fund, establishes a biennial vaccine priority list. The list categorizes vaccines that are anticipated to be available for supply before the end of the biennium according to four levels of priority: high, medium, low and no priority. Vaccines listed as “no priority” cannot be considered for prequalification. All other vaccines will be accepted according to priority order and resources available within WHO.
    • evaluating vaccines for prequalification: Manufacturers of vaccines that comply with the priority list may apply for prequalification by completing a WHO vaccine prequalification dossier  Each application will be comprehensively screened and evaluated following the prequalification procedure which includes: a review of the vaccine production process; quality control procedures and available clinical data relevant to the target population; verification of compliance with required WHO standards and other best practices, and an inspection of the product manufacturing site(s). A streamlined procedure may be used in selected cases, where the responsible national regulatory authorities are eligible and willing to share regulatory information with WHO through a “collaboration agreement”.
    • regularly re-evaluating prequalified vaccines: A post-prequalification process is also in place to ensure the continued acceptability of vaccines that have been prequalified. Post-prequalification requirements include the submission and evaluation of annual reports, reassessments of product at regular intervals, targeted testing of vaccine lots to monitor compliance with product standards, and follow-up of quality complaints.
  • WHO vaccines prequalification applies WHO-established vaccine standards, norms and other recommendations as they become available. These include standards and norms developed and adopted by the WHO Expert Committee on Biological Standardization and which cover vaccine standards that address the manufacturing, licensing, quality control, labelling, transportation and storage of vaccines. Vaccines prequalification also enforces adherence to good manufacturing processes, good clinical practice and the operational packaging and presentation requirements of the relevant procurement agencie(s).

  • Any manufacturer of a vaccine that fulfils two preconditions may submit an application for prequalification:

    • the vaccine is included on the priority list
    • the national regulatory authority (NRA) responsible for regulatory oversight in the vaccine’s country of manufacture is confirmed as functional or with the required “maturity level” as per the WHO Global Benchmarking Tool.

    If these conditions are met, the manufacturer may apply for prequalification by:

    • communicating its intention to submit a vaccine for evaluation as early as possible, by sending an official letter of intent to WHO
    • attending a pre-evaluation meeting with the WHO and the responsible NRA if necessary
    • submitting a comprehensive application information in the form of a WHO Vaccine Prequalification Dossier which is based, in structure and content, on the International Conference of Harmonization (ICH) common technical document
    • providing an appropriate number of vaccine samples for WHO independent testing, accompanied by lot summary protocols.
  • Vaccines that fulfil four preconditions are eligible for prequalification:

    1. the candidate vaccine is on the current priority list
    2. the candidate vaccine meets the mandatory characteristics for programmatic suitability
    3. a marketing authorization has been granted by the relevant national regulatory authority (NRA) and the post-marketing regulatory oversight is under the responsibility of the NRA of record
    4. the NRA responsible for regulatory oversight in the vaccine's country of manufacture is confirmed by the WHO Global Benchmarking Tool to have the required "maturity level".
  • The timeframe for full (standard) assessment takes up to 270 days while the timeframe for streamlined assessment takes up to 90 days. For both full (standard) and streamlined assessment, the time taken by the manufacturer to respond to WHO queries (if needed) will be in addition to these timeframes. 

    Fees are incurred for:

    • screening of an application
    • dossier evaluation
    • site inspection
    • annual maintenance.

    The fees are based on the type of vaccine and the type of evaluation process that is required. Prequalification fees for "simple" vs. "traditional" vaccines are overall lower compared to those for "combination" or  "novel" vaccines.

  • Vaccine evaluation for WHO prequalificationincorporates:

    • review of general, administrative and specific information that is relevant to the vaccine and the global supply, including programmatic issues and stability data to support the use of vaccine vial monitors
    • verification that the safety and efficacy data that support the claims of the manufacturer
    • review of general production process and quality control procedures,
    • testing of the consistency of vaccine lots
    • WHO site inspection to manufacturing facilities with observers from the responsible national regulatory authority.

    Upon completion of these phases, WHO prepares a report of the outcomes of the assessment and inspection(s) and sends it to the manufacturer. The responsible NRA is also copied. In the case of a satisfactory outcome the WHO will grant the product prequalified status. 

    When applying the streamlined-procedure, WHO relies on the oversight of the responsible NRA, when that authority is considered to be stringent. In such cases, WHO may decide, on a product-by-product basis, to rely on one or more of the following:

    • the NRA assessment reports
    • review of NRA/national control laboratory testing results, if applicable (rather than independent testing carried out by WHO)
    • review of the NRA inspection reports which WHO may decide to supplement with a short audit (instead of a full site inspection), focused on aspects related to UN tender specifications.

    WHO also has an emergency use assessment and listing procedure. This can be applied during public health emergencies of international concern, for example. It is not a WHO prequalification procedure but a procedure aimed at making urgently-needed but as yet unlicensed products available for a limited period. EUL assessment is based on a predetermined, minimal amount of product quality, safety and efficacy information, while further data continue to be gathered and evaluated. In other words, EUL is a risk-based procedure.

  • Yes. WHO has established three deadlines per year for the submission of an application:

    • 31 January
    • 31 May
    • 30 September.

    In each case, an application must arrive at WHO by the submission date in order to be considered for the subsequent round of review. Applications received after the submission deadline will not be considered for evaluation until the following review round.

  • A prequalified vaccine will retain its prequalified status provided that:

    • no reports of serious adverse events following immunization (AEFIs) are received from product users
    • the manufacturer meets post-prequalification requirements.

    In most cases, a product's prequalified status is withdrawn voluntarily by a manufacturer due to the discontinuation of production or commercialization. In this case, manufacturers must provide WHO with the end of shelf-life date of the last batch produced, in order to remove the product from the vaccines’ prequalification website once the shelf-life has expired.

    In rare cases, prequalified status may also be withdrawn by the WHO pending further investigation, if the manufacturer:

    • does not fulfil post-prequalification requirements
    • does not provide mandatory documents and information required for annual review
    • does not (fully) comply with the requirements and information requested for periodic product reassessment

    or if:

    • vaccine quality complaints from testing laboratories, or reports of serious AEFIs, are received by WHO.

    In some cases that WHO decides to withdraw the prequalified status of a vaccine based on quality or safety issues communicated by product users or national regulatory authorities or national control laboratories. In most of these cases, a Prequalification Ad-hoc Committee will be convened and its advice requested.

  • Manufacturers of prequalified vaccines are required to observe several post-prequalification commitments and procedures in order to maintain the prequalified status of their vaccine. They must:

    • notify WHO of any product variations: all changes that impact product safety or efficacy, alter the basis of regulatory approval or change packaging must be communicated to WHO (and be included in the annual report)
    • promptly report any quality and safety complaints to WHO: this includes providing all data reports, batch records and other information to facilitate WHO investigation
    • submit annual reports: these must contain, for each prequalified vaccine, a summary of variations made to the product since the previous annual report, testing results from the on-going stability programme, update on implementation of post-prequalification commitments (if any), notification of any problem/constraint in product or quality control, inspections carried out by regulatory bodies, information on production and distribution data, and the Periodic Safety Updated report
    • provide sample lots for testing: three to five sample lots to be provided at least once a year, from which samples can be selected for testing to verify continued compliance with prequalification requirements
    • facilitate periodic reassessment: provide comprehensive information on the product to enable continued follow-up or monitoring.
  • Information about prequalification of vaccines, as well as a full listing of the vaccines available for procurement, can be accessed here. The WHO vaccine priority list for 2018‒2020 (i.e. vaccines currently eligible available for prequalification) is available here. All of this information is intended to facilitate effective procurement decision-making based on national immunization priorities and operating contexts. UN and other procurement partners can also access guidance on how to locate and select vaccines that are appropriate for each operating context and which match national immunization priorities.

  • The total time to prequalification of a finished pharmaceutical product (FPP) (if full assessment is carried out) depends on the quality of the submitted dossier, and the quality and promptness of the applicant’s subsequent replies to PQTm’s questions during the assessment process, and the results of any inspection carried out. The median WHO time to prequalification has consistently been around 200 days during the past few years. Prequalification of a stringently-approved FPP (i.e. a product already approved by a stringent regulatory authority) does not involve reassessment of the SRA-approved dossier. Instead, PQTm verifies that the product submitted is the same as the one that received SRA approval. The total WHO time to prequalification of an SRA-approved FPP is generally one to two months (median).

    The total time to prequalification of an active pharmaceutical ingredient (API) will be reviewed later in 2016 when the benefit of additional resources is expected to become evident.

    The total time to prequalification of a medicines quality control laboratory (QCL) is strongly dependent on the outcome of the inspection and, if needed, the speed and efficiency with which the QCL carries out corrective and preventive actions (CAPAs). A QCL may be prequalified immediately after initial inspection (usually conducted within six months of application for prequalification), if no CAPAs or reinspection were required. A shorter timeline of one to two months is possible if a the  QCL can provide a report of an inspection or audit performed  by a regulatory authority that applies standards that are at least equivalent to WHO-recommended quality standards for QCLs.

  • The approval represented by inclusion of a finished pharmaceutical product (FPP) in the WHO List of Prequalified Medicinal Products, of an active pharmaceutical ingredient (API) in the WHO List of Prequalified Active Pharmaceutical Ingredients, or of a quality control laboratory (QCL) in the WHO List of Prequalified Quality Control Laboratories, is not valid indefinitely and must be actively maintained.

    FPPs: As well as continuing to meet prequalification requirements on an ongoing basis, FPPs are subject to requalification. All FPPs are subject to requalification after five years. Additionally, in the event of notification of a product complaint, PQTm will generally carry out further product assessment and possibly also inspect the manufacturing site(s). And to verify that the quality of prequalified products is being maintained, WHO carries out random quality control testing of prequalified FPPs that have been supplied to countries.

    APIs: Prequalified APIs are not subject to requalification but certain requirements must be met if prequalification status is to be retained. Holders of prequalified APIs must ensure the accuracy of the information contained in the API master file and:

    • provide all necessary documents to WHO to demonstrate that any change will not or has not had a negative effect on the API’s quality or safety
    • communicate information about any changes made to the API to FPP manufacturers who manufacture FPPs with that API.

    QCLs: Although prequalified QCLs do not undergo requalification at any stage, ongoing monitoring of the activities of prequalified QCLs is carried out. This includes reinspection at regular intervals (at least once every three years), evaluation of results from participation in an appropriate proficiency testing scheme, and monitoring and investigation of complaints concerning the results of analysis or service provided by the listed laboratories. To facilitate the monitoring each prequalified laboratory is requested to submit a brief annual report on its activities related to quality control of medicines

  • The WHO List of Prequalified Medicines Products was originally intended to provide UN agencies, such as UNICEF, with a range of quality medicines to select from. With time, the growing list of products has become as a useful tool for any agency or organization undertaking bulk purchasing medicines.

    The WHO List of Prequalified Active Pharmaceutical Ingredients (APIs) is used by manufacturers seeking quality-assured APIs for manufacture of finished pharmaceutical products (FPP). It is also used by national medicines regulatory authorities to validate the quality of FPPs when reviewing applications for marketing authorization. Procures also use the list when considering procurement of FPPs manufactured by the same applicant, or at a site at which a prequalified API is manufactured.

    The WHO List of Prequalified Quality Control Laboratories is used, among others, by procurers, ministries of health, health care organizations and donors who need to organize testing of medicines at a laboratory and wish to be assured that the laboratory selected meets international standards and can provide the type of testing required.

  • Fees are levied for evaluation for prequalification for active pharmaceutical ingredients (APIs) and finished pharmaceutical product (FPPs), and for evaluation of major variations for prequalified FPPs. An annual fee is also levied for each prequalified API or FPP. In some instances, deferred fees may be applied.

    In considering an application for prequalification evaluation, manufacturers should also consider the common expenses involved in preparing a product for WHO or other stringent evaluation.

    The majority of quality control laboratories (QCLs) that WHO prequalifies are national laboratories or academic institutions, the financial resources of which are often limited. WHO therefore decided not to levy a fee for QCL prequalification.

  • All members of staff working on medicines prequalification are bound by confidentiality agreements. Likewise, in accordance with the terms contained in an agreement which they are requested to sign, appointed experts (assessors, inspectors and technical assistance providers) commit to treating all information to which they have access during product dossier assessment, or site inspection, or provision of technical assistance, as strictly confidential, and proprietary to WHO, or to parties collaborating with WHO.