Technical Advice

WHO prequalification requirements for finished pharmaceutical products and active pharmaceutical ingredients are based on international, pharmaceutical norms and standards. Meeting these can be challenging for manufacturers. WHO prequalification assessors and inspectors therefore welcome the opportunity to provide technical and scientific advice to manufacturers, either in response to questions forwarded by email, or at a meeting (be this face-to-face or via tele- or videoconference).
 

Type of advice that PQ Medicines can provide

Technical advice: in writing

Potential applicants or applicants may forward a request for technical advice to prequalification assessors (by emailing prequalassessment@who.int) or prequalification inspectors (by emailing prequalinspection@who.int) at any time, and can expect a response within a few hours or a few days, depending on the complexity of the question(s).  

Technical advice: in person

WHO prequalification assessors are available to meet with applicants either before ("pre-submission" meeting), or at any stage following submission of a dossier. Meetings can thus be organized with reference to a new or to an ongoing application. Participation of WHO prequalification inspectors in these meetings can be arranged if this is considered necessary or would be helpful.

The primary purpose of such meetings is to resolve or clarify technical issues that cannot be addressed easily by other means, such as email exchange. These issues may be general — for example, relating to WHO prequalification procedures — or specific — for example, concerning prequalification requirements relating to pharmaceutical quality or efficacy/safety. Applicants may request a face-to-face meeting or a meeting in the form of a teleconference or videoconference.

In some cases, questions or issues relating to a dossier or to a manufacturing site — especially those relating to dossier compilation or to requirements regarding for example, WHO Good Manufacturing Practices or WHO Good Clinical Practices for Trials on Pharmaceutical Products are best dealt with through independent technical assistance, rather than through a meeting with WHO prequalification assessors or inspectors. If this becomes apparent, the applicant may be referred to the separate unit within the WHO Prequalification Team that handles technical assistance. Strict criteria are applied to provision of technical assistance: it is organized and performed completely independently of assessment and inspection activities.

Additionally, with prior agreement, WHO can provide comments on a protocol submitted for review; a meeting may not be necessary. Such advice can be provided only once per protocol and on the understanding that WHO neither "approves" nor "accepts" study protocols. The review of a protocol generally takes between one and two weeks, depending on the availability of expert reviewers.

Questions relating to the status of dossier assessments can also be (and are best) sent by email to prequalassessment@who.int.

Similarly, any questions about WHO inspections should be emailed to prequalinspection@who.int.

How to request a meeting

A face-to-face meeting, teleconference, or videoconference may be requested by completing a Meeting Request Form. The request will be reviewed and if a meeting is considered to be worthwhile, WHO will confirm the suggested date of the meeting, or propose alternative dates, depending on the availability of any needed experts, as well as the most appropriate location if the meeting will be face-to-face. Face-to-face meetings are generally held in Geneva, Switzerland or Copenhagen, Denmark. Meetings in Copenhagen are held in conjunction with dossier assessment sessions, or the annual meeting with manufacturers, and benefit from the increased availability of experts.

The applicant may be requested to provide an information package, to be received at least one week before the face-to-face meeting, tele- or videoconference, so that WHO staff can prepare adequately.

Applicants are requested to draft meeting minutes that summarize the important discussion points, decisions, recommendations, agreements, disagreements, issues for further discussion and action items. These must be emailed for review and comment to all those who attended, before they can be considered as final.

Note

In accordance with WHO Staff Regulations and Rules, gifts or favours offered in connection with duties will be refused. To avoid embarrassment, applicants and manufacturers are therefore requested not to offer any gifts or favours.