Support to Manufacturers, CROs and QCLs
Any active pharmaceutical ingredient (API), finished pharmaceutical product (FPP) or medicines quality control laboratory (QCL) for which prequalification is sought must meet international pharmaceutical standards. Recognizing that this can be difficult for manufacturers and QCLs, WHO makes available technical advice and technical assistance to help them understand and work out how to meet prequalification requirements, and, in the case of specific deficiencies how to overcome them.
Technical advice can be sought at any time by an applicant or manufacturer of APIs or FPPs that is invited for evaluation for prequalification. Advice can be provided as a written response or during a meeting (e.g. in videoconference or one-to-one).
Pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicines assessors who will be involved in assessing their product.
Specialized technical assistance
WHO provides 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.