WHO provides specialized technical assistance to help recipients achieve compliance with international regulatory norms and standards, so that they can attain WHO prequalification for priority products or services and/or supply quality-assured products required by United Nations (UN) Agencies, their partners and procurement agencies serving WHO Member States. Products eligible for WHO prequalification are listed in Invitations to Manufacturers to Submit an Expression of Interest for Product Evaluation (EOIs).

Specialized technical assistance is organized by WHO's Local Production and Assistance Unit.

Who can apply?

Specialized technical assistance is available for:

• manufacturers from low-income countries who:
  • produce or plan to produce priority active pharmaceutical ingredients (APIs) or finished pharmaceutical products (FPPs), as listed on current EOIs
  • intend to seek prequalification so that they can participate in tenders issued by UN-procuring organizations
• contract research organizations (CROs) that provide services to manufacturers of low- and/or middle-income countries (LMIC), and who conduct or plan to conduct clinical studies for FPPs listed on current EOIs
• national quality control laboratories (QCLs) that  provide testing services for their government and have applied for WHO prequalification, or exceptionally, QCLs that conduct or plan to conduct quality control testing for UN agencies, their partners, procurement agencies serving national authorities, and/or national authorities of WHO Member States, and that have applied or are planning to apply for WHO prequalification, as described in the current  Invitation to Quality Control Laboratories to Submit an Expression of Interest for Prequalification
• medicines QCLs that provide quality control testing services to LMIC manufacturers that produce or plan to produce APIs or FPPs listed on the current EOIs for prequalification.

What areas are covered?

Technical assistance experts work with manufacturers, CROs or QCLs to develop capacity to achieve compliance with international and WHO norms and standards to attain WHO prequalification. For example, for manufacturers this may relate to preparation of product dossiers and/or their achieving compliance with WHO Good Manufacturing Practice (GMP) while QCLs may require assistance to achieve adherence with WHO Good Practices for Pharmaceutical Quality Control Laboratories and CROs with WHO Good Clinical Practices for Trials on Pharmaceutical Products and Good Laboratory Practices applicable to bioequivalence testing. For QCLs, it may relate to compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories.

For manufacturers technical assistance may include:

• selection of optimal products for prequalification and agreement on a product development plan
• a quality management system audit or WHO GMP pre-inspection, which may include the QCL
• development of a corrective and preventive action plan
• preliminary review of data intended to be submitted as part of an application for prequalification
• compilation of API or FPP dossier for submission to WHO for evaluation for prequalification
• organization of training workshops on specific topics requested by manufacturers.

For CROs technical assistance may include:

• an audit of the quality management system (QMS)
• analytical methods that would be applied in generating data relating to FPPs invited for WHO prequalification
• audit of a study already conducted by the CRO and that would be similar to a study to be conducted for an FPP invited for WHO prequalification
• preparation of documentation to be included in an FPP dossier to be submitted for evaluation for WHO prequalification and/or to a national regulatory authority for registration.

For national QCLs technical assistance may include:

• a focus on QMS implementation in the laboratory
• a focus on test methods, such as microbiological testing, that would be considered during an evaluation for prequalification of the QCL
• training in special topics of current interest for meeting WHO and other international norms and standards
• development of a corrective and preventive action plan
• advice on the design of laboratory premises.

What is the procedure for requesting technical assistance?

A manufacturer, CRO or QCL can contact WHO directly to request specialized technical assistance.

Alternatively, following review of a product dossier or laboratory information file, or inspection of a manufacturing site or QCL, prequalification assessors or inspectors may propose that technical assistance be provided to a manufacturer, CRO or QCL. Technical assistance can also be proposed by other parties such as international procurers or government ministries. Whichever case applies, the recipient will be requested to provide a signed Letter of Agreement for Specialized Technical Assistance prior to the provision of technical assistance.

Potential recipients are expected to:

• declare to WHO their intent to submit an API or FPP for evaluation for prequalification (in the case of manufacturers), or confirmation of readiness for inspection for prequalification (in the case of QCLs), following conclusion of technical assistance
• be transparent regarding any similar technical assistance that is being or will be provided by other organizations or under donor-driven projects
• designate a focal point for each technical assistance mission and coordinate all aspects of the mission, including follow-up activities
• facilitate the visits of technical assistance experts, by providing administrative support  for visa applications, transportation to the relevant site and/or accommodation, a skilled interpreter, and translations of relevant documents, if required
• provide the technical assistance expert(s) with the necessary information and documentation before, during and after the technical assistance, and cooperate with the expert(s) and WHO on all matters relating to the technical assistance 
• agree on mutually-acceptable technical solutions and steps to be followed with the technical expert(s), and provide WHO with progress reports within the agreed deadlines, if requested
• agree that WHO can make public their names as recipients of technical assistance 
• provide WHO with an evaluation of the conduct and usefulness of the technical assistance provided.

How is technical assistance provided?

Following receipt of a Letter of Agreement, technical assistance is initiated with a discussion with the intended recipient about a plan for attaining prequalification. This may be followed by a three‒ to five‒day visit from a technical expert to the recipient's premises. The visit will begin with an audit (evaluation of current deficiencies) and be followed by consultation on the plan of corrective action and on any needed training. In the case of technical assistance to manufacturers, a review of existing quality documentation for an FPP that it is intended to be submitted for prequalification is organized, and an agreement reached on data completion, if necessary. Advice on data completion can be organized by correspondence. Where appropriate, the national regulatory authority (NRA) may be invited to participate in provision of technical assistance.

Care is taken to ensure avoidance of any conflict of interest with WHO prequalification and with respect to individual sites covered by the technical assistance. In particular, technical assistance experts that have provided, or are providing, technical assistance to a recipient are not permitted to participate in the assessment of any API or FPP or site inspection for WHO prequalification of the API and/or FPP manufactured by that recipient. The same applies to QCLs undergoing WHO prequalification.

Site inspections and evaluations of product dossiers performed for WHO prequalification are independent of the outcomes of technical assistance. Information gathered during the technical assistance visits is not shared with WHO prequalification and remains confidential.

Technical assistance is provided free of charge, but recipients may be requested to contribute towards the local costs associated with the visits of technical assistance experts as described above. The following conditions apply:

• technical activities may be combined — such as pre-inspections and data review — aimed at assessing the intended recipient's potential to achieve technical assistance milestonesa combination of remote, on-site support and training may be used when providing technical assistance
• provision of technical assistance with capacity building of other parties may be combined, for example, inviting NRA inspectors to participate in or observe audits
• provision of specialized technical assistance may be prioritized, for example, for APIs and/or FPPs that would have a high public health impact if prequalified, or if less than three urgently needed products have been prequalified and less than two such products are under assessment.

WHO ensures that the confidentiality of commercially-sensitive and other information obtained during provision of technical assistance is respected. The observations and recommendations of the technical experts are shared with the recipient (but excluding those specifically addressed to WHO). Any information obtained during the provision of technical assistance can be made available to third parties only with the recipient's consent.

WHO reserves the right to request additional information from the organization that has requested assistance and to decide whether to meet the request, taking into account the need for the relevant FPP(s), availability of WHO resources and any other relevant factors. WHO will respond within 60 days (excluding any time required to request and receive additional information) to the request for technical assistance.

What are the expected outcomes?

Technical assistance is deemed successful if it enables a recipient to submit an API or FPP dossier for WHO prequalification and pass the initial screening and/or successfully undergo WHO inspection without any critical or a high number of major observations. In so doing, the recipient will have improved the quality of its API or FPP, or its testing services, and reduced the time to prequalification.

More generally, technical assistance can be seen as a means of improving the quality of locally-produced medicines and of promoting adherence to international pharmaceutical and prequalification standards.

Experience to date has also shown that provision of technical assistance can increase a government’s awareness of the value of strengthening regulatory requirements and the commitment of manufacturers to meeting them.