Regulatory Approval


Regulatory Approval

The best part of conducting BE studies with IPRC is the predictability of the regulatory process. IPRC professionals ensure the total elapsed time from protocol's approval by the sponsor to the start of subjects' dosing in 4 weeks as follows:

  • The accredited Ethical Committee of IPRC meets weekly, therefore, a decision on a protocol is emitted always in 1 week.
  • Protocols' submission to Jordan Food and Drug Administration (JFDA) by IPRC is fluent and continuously monitored. The regulatory approval time is 2 weeks.
  • IPRC releases on products shipment from Customs in 24 hrs.  IPRC does not need import license.

IPRC guarantees fast preparation of submission package to JFDA.  The required documents are:

  • IPRC protocol approved by the sponsor and the Ethical Committee.
  • Certificates of analysis of Test and Reference products.
  • Product's outer box and leaflet.