JFDA eCTD

Jordan Food and Drug Administration – Jordan

Country: Jordan
Health Authority: Jordan Food & Drug Administration
eCTD, Accepted Since: March 1, 2019
eCTD Version: Module 1 Specification v1.1

Types of Applications

  • Asmf – Active Substance Master File
  • Cep – Certification of suitability of Monographs of the European Pharmacopoeia
  • Extension – Extension Submission
  • Ord – MAA – Originator Drug
  • Orv – MAA – Originator Vitamin Drug
  • Orn – MAA – Originator Narcotics
  • Bgd – MAA – Generic Drug
  • Bgv – MAA – Generic Vitamin Drug
  • Bgn – MAA – Generic Narcotics
  • Mnd – MAA – New Drug
  • Nvd – MAA – New Vitamin Drug
  • Nnd – MAA – New Narcotics
  • Rrp – MAA – Radiopharmaceutical Ready-for-use Radioactive Product
  • Rnr – MAA – Radiopharmaceutical Non-Radioactive Components (kits)
  • Hrd – MAA – Herbal Drug
  • Bld – MAA – Biological Drug
  • Blv – MAA – Biological Vaccine
  • Blb – MAA- Biological Blood Product
  • Bla – MAA – Biological Allergen
  • Bls – MAA – Biological Bio-similar
  • Vam – MAA – Value added medicine
  • Vtr – MAA – Veterinary Drug*
  • None – In the exceptional case of reformatting the application no regulatory activity is allowed. Therefore, ‘none’ must be stated. The submission unit will identify the sub-activity related to the product.
  • Pmf – Plasma Master File
  • Pbrer – Periodic Benefit-Risk Evaluation Report
  • Psur – Periodic Safety Update Report
  • Psusa – PSUR single assessment procedure
  • Renewal – Renewal of Marketing Authorization (every 5 years)
  • Rmp – Risk Management Plan
  • Transfer-ma – Transfer of Marketing Authorization
  • Usr – Urgent Safety Restriction
  • Var-tca – Technical Committee Approval
  • Var-ra – Registration Department Approval
  • Var-n1 – Notification without pricing
  • Var-n2 – Notification with pricing
  • Withdrawal – Withdrawal of a marketing authorization in regard to a strength or dosage form or entirely. This submission type shall not be used to withdraw a regulatory activity

Process

  • Learn about the Jordan M1 Specification for eCTD requirements
  • Review the eCTD submission guidance
  • Submit administrative forms and compliant PDFs
  • Request for the application number
  • Submit the eCTD submission via electronic media

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