Regulatory Agencies

Since its inception, regulatory agencies have both supported WHO medicines prequalification and benefited from it. They can be seen as an important community that joins forces to help make quality priority medicines available for those who urgently need them.

Stringent regulatory agencies (SRAs)

SRAs provide critical expertise for the evaluation of finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs) for prequalification. This includes:

  • participating in the WHO Prequalification Team (PQTm) assessment sessions that take place every two months in Copenhagen, Denmark, to share their expertise and work with PQTm to resolve technical pharmaceutical issues relating to dossier assessment
  • participating in WHO inspections of manufacturing sites, contract research organizations and quality control laboratories, helping PQTm to ensure that its inspection standards and approaches are fully aligned with current practice
  • working with PQTm to develop prequalification guidance that will help manufacturers to understand and meet prequalification requirements
  • participating in individual meetings with manufacturers, and in training workshops for manufacturers, to provide technical advice that will enable them to meet prequalification requirements more quickly and more efficiently
  • participating in training for low- and middle-income country medicines regulators to facilitate understanding of WHO prequalification requirements and enhance their expertise in applying international standards for assessment and inspection.

Much of the support has been and continues to be provided at no or little cost to WHO, reflecting recognition of the public health value that WHO prequalification brings. PQTm welcomes expressions of interest from SRAs regarding possible participation in prequalification activities.

Regulatory agencies of low- and middle-income (LMIC) countries

For regulatory agencies of low- and middle-income countries (LMICs), WHO prequalification is as a source of rich learning and training opportunities. These include:

  • participation in the annual assessment training session
  • participation in the WHO Prequalification Team (PQTm) assessment sessions that take place every two months in Copenhagen, Denmark
  • participation in PQTm inspections as an observer
  • the opportunity to work with PQTm as a rotational assessor or inspector
  • participation in training workshops on prequalification requirements and current regulatory issues of relevance to prequalification and regulation of priority medicines
  • participation in the WHO Collaborative Procedure for Accelerated Registration.

Usefulness of WHO technical outputs of medicines prequalification

LMIC regulators also appreciate both the technical underpinning (the norms and standards on which it is based) and the outputs of WHO prequalification. The latter can enable savings to be made in time and resources when conducting regulatory activities.

The most useful sections on this website for LMIC regulators are:

  • Procedures and Fees — presenting all the requirements that must be met for prequalification, be this of an FPP, API or quality control laboratory
  • Prequalification Pipeline — summarizes what has been prequalified and what is currently under assessment
  • WHO List of Prequalified Medicinal Products — what FPPs have been prequalified and when, in what therapeutic area, dosage, form and strength; and where manufactured
  • WHO List of Prequalified Active Pharmaceutical Ingredients — what APIs have been prequalified and when; where; with what packaging, re-test period or shelf life and storage conditions
  • WHO List of Prequalified Quality Control Laboratories (QCLs) — details of QCLs prequalified, including when, where and type of expertise inspected and considered prequalified
  • Prequalification Reports — WHO Public Assessment Reports describe the products that have been prequalified and WHO Public Inspection Reports describe the manufacturing sites and contract research organizations (and also the quality control laboratories) that have passed WHO inspection
  • Guidance Documents — WHO guidelines underpin WHO medicines prequalification and define the requirements that must be met, WHO prequalification guidance offers manufacturers valuable direction with respect to specific aspects of prequalification and The International Pharmacopoeia gives quality specifications for selected pharmaceutical products, excipients and dosage forms
  • Collaborative Procedure for Accelerated Registration — describing an innovative WHO procedure that offers regulators the opportunity to optimize use of their human and financial resources, as well as enhance assessment expertise
  • Key Contacts — the key persons who can be contacted regarding different aspects of prequalification, or collaborative registration or technical assistance.

In their turn, LMIC regulators bring their own experience of regulating APIs and FPPs to WHO prequalification. This is of great value with respect to FPPs that are considered to be priority products in LMIC but that are not greatly used in many high-income countries. Moreover, having participated in training activities organized by PQTm, LMIC regulators are more expert in applying international regulatory standards and supporting regulatory harmonization within their geographic region.

For all regulators, the Notices of Concern or Suspension issued by PQTm are an important source of information, alerting them to quality issues relating to specific APIs or FPPs, that may have entered or could enter their markets.