The WHO List of Prequalified Medicinal Products is updated regularly, generally with the inclusion of newly-prequalified products.
Medicinal products (as identified in the Invitations to Manufacturers to Submit for Expressions of Interest for Product Evaluation (EOI) issued by WHO) are added to the list after the data submitted for an invited product has been evaluated, and relevant sites have been inspected by WHO, and are considered (at the time of evaluation and inspection) to meet WHO prequalification requirements. WHO cannot guarantee that the listed products and manufacturing sites will continue to meet the aforesaid standards, and may suspend or remove products from the list, based on information that has subsequently become available to it.
Please note that:
- The list is not an exhaustive list of medicinal products used in the treatment of HIV/AIDS, tuberculosis, malaria or other diseases, or for reproductive health. It reflects those products which, following a selection, have been listed in the respective EOI and have been submitted for evaluation by interested parties.
- The fact that certain products and suppliers are not included in the list does not mean that if evaluated and tested, they would not be found to comply with the above-mentioned standards.
- Inclusion in the list does not imply any approval by WHO of the products and manufacturing sites in question (which is the sole prerogative of national authorities).
- This list may not be used by manufacturers and suppliers for commercial or promotional purposes.
- Please note that more information concerning the product(s) is displayed when the list (or selected products on the list) is (are) downloaded as an Excel spreadsheet. This is due to space limitations on the web pages.
Listing of prequalified medicinal products
- In addition to medicinal products that are listed based on evaluations and inspections carried out by WHO prequalification, WHO may list products relying on the assessment and inspection carried out by certain regulatory authorities.
- WHO recognizes the evaluation of innovator and generic products by regulatory authorities that apply stringent standards for evaluating quality, safety and efficacy similar to those recommended by WHO. (See Clarification with respect to a stringent regulatory organization as applicable to the stringent regulatory authority (SRA) guideline (15 February 2017).
- When the product has been approved by an SRA, WHO's work is essentially an abridged procedure to verify that the product submitted to WHO PQ is indeed the one approved by the SRA. For further details see Prequalification by the SRA route. This guidance requires that the product is on the market of the SRA. Products covered by the alternative listing procedure are therefore excluded (see below).
- Where a product is listed with a reference to "USFDA" or "EMA", the alternative listing procedure was used (see below).
Alternative listing procedures
US FDA-approved/tentatively approved products
- The products listed with the reference "USFDA" have been added to the list of medicinal products prequalified by WHO, on the basis of assessments and inspections conducted by US FDA. Provision is made for the exchange of relevant information between the US FDA and WHO (under the terms of a corresponding confidentiality agreement).
- The products listed with a note, "USFDA1", have been approved by the US FDA for marketing in the US. The products listed with a note, "USFDA2", have been approved tentatively by the US FDA. This means that although existing patents and/or other exclusive rights prevent marketing of the product in the USA, the product meets all of the US FDA's safety, efficacy, and quality standards required for marketing in the USA. Upon expiry of the patent protection or other exclusive rights in the USA, tentatively-approved products will be authorized for marketing in the USA.
- The products listed with the reference "EMA" have been added to the list of products prequalified by WHO on the basis of assessments and inspections conducted by EMA, according to Article 58.
- Article 58 of the European Commission (EC) regulation No. 726/2004 established a mechanism whereby EMA may give a scientific opinion within the context of its cooperation with WHO, with respect to the evaluation of certain medicinal products for human use that are intended exclusively for markets outside the European Community.
- For a given medicinal product, EMA's Committee for Medicinal Products for Human Use provides a scientific opinion assessment report containing conclusions relating to its quality, safety and efficacy. These conclusions take into account appropriate benefit : risk scenarios with respect to the populations for whose use the product is intended, as well as conditions of use as documented with clinical data by the applicant.
- Please note, innovator products approved by EMA for its own market (i.e. the European Union) are prequalified by WHO according to its guidance for prequalification by the SRA route. Because such products are included in the prequalified list based on WHO's assessment of a submitted dossier, these products are listed with a WHO reference number (see above) and not with the label "EMA".
Suggestions relating to procurement
- Any UN organization intending to use the list of prequalified products for procurement should ensure that only products from the manufacturing sites mentioned in this list are supplied to it.
- Procurement organizations using this list for procurement should perform other aspects of qualification prior to purchasing, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities and other related aspects, including the registration status of the products they wish to procure.
- This list does not constitute any guarantee regarding the procurement of the products from the suppliers mentioned.
Disclaimer to the WHO List of Prequalified Medicinal Products
- Inclusion in this list does not constitute an endorsement, or warranty of the fitness, by WHO of any product for a particular purpose, including in regard to its safety and/or efficacy.
- WHO does not furthermore warrant or represent that:
- the list is complete or error free; and/or that
- the products and manufacturing sites which have been found to meet the standards recommended by WHO, will continue to do so; and/or that
- the products listed have obtained regulatory approval for its specified use or any other use in any country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws.
- In addition, WHO wishes to alert procuring agencies that the improper storage, handling and transportation of medicinal products may affect their quality, efficacy and safety. WHO disclaims any and all liability and responsibility for any injury, death, loss, damage or other prejudice of any kind whatsoever that may arise as a result of or in connection with the procurement, distribution and use of any product included in the list.