Objectives

Objective and purpose of its formation Initiative to collaborate in assessment and inspections for medicines registrations with objectives to:

  1. Reduce workload
  2. Reduce timelines to registrations
  3. Develop mutual trust and confidence in regulatory collaboration
  4. Platform for training and collaboration in other regulatory fields

How it works

Evaluations, registration, inspections Countries work on common applications (dossiers) which are submitted for registration. A manufacturer who submitted an application to at least two of the participating countries can request to have their products assessed jointly (via Zazibona). Alternatively regulators in the different countries can identify some common applications which are pending in their respective countries and request for to conduct joint review of such common applications. One country then assesses the product, another country conducts peer review and outcomes are then shared with the rest of the countries who can then use the outcomes of assessment in their own countries thus avoiding duplication of work. WHO For the same applications, GMP inspections are then carried out on the manufacturing sites where the products which are considered for joint assessment are manufactured. Once the assessment of the applications (dossiers) and GMP inspection is considered acceptable, the participating countries will then use the outcomes form Zazibona to facilitate either registration or rejection of the concerned products.

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