المادة 10 من تعليمات إجازة الاستخدام الطارىء للأدوية Emergency Use Authorization of Medicinal Product رقم 0 لسنة 2021

تستثنى الأدوية الحاصلة على إجازة الاستخدام الطارئ من تطبيق أحكام المادة (6/ب) من أسس تسجيل الدواء لسنة 2015 وتعديلاته. Table of Contents Abbreviations 3............................................................................................................. 6 :Introduction -1 6 :Scope of this guidance -2 7 :Criteria for Issuance -3 8 EUA activities and submissions-Pre -4 9 EUA request -5 9 : Regulatory Documents 9 :Summary of recommended information -A 11 Recommended Safety Information .B 12 Recommended Effectiveness Information .C 13 Other Data Considerations .D 15 Discussion of Risks and Benefits .E 15 Format of Submissions -6 16 EUA Request JFDA Processing and Prioritization -7 16 Review of EUA Requests -8 17 EUA request rejection ,EUA issuance -9 17 CONDITIONS OF AUTHORIZATION -10 17 Information relating to authorized product Information for Health Care Professionals or Authorized -A 17 :Dispensers 18 :Information for patients -B 19 Monitoring and Reporting of Adverse Events -11 periodic safety update reports & (RMP) Risk management plan -12 19 Submission (PSUR) 19 :Termination of an EUA Declaration -13 20 PUBLICATION JFDA -14 20 :Reference -15 21 Annex I 21 (Specific documents) Emergency Use Authorization for Vaccines Summery of recommended ,Annex II 15.........................................................................................information Abbreviations Active Pharmaceutical Ingredient :API European Medicine Agency :EMA Emergency Use Authorization :EUA .Food and Drug Administration :FDA Finished Product :FP Good Clinical Practice :GCP Good Laboratory Practice :GLP Good Manufacturing Practice :GMP Jordan food and drug administration :JFDA Ministry Of Health :MOH patient information leaflet :PIL Periodic Safety Update Reports :PSUR Rational Drug Use Department :RDU Risk Management Plan :RMP Summery of product Characteristics :SmPC World Health Organization :WHO European Union Drug Regulatory Authorities :EUDRA EMERGECNY USE AUTHORIZATION OF MEDICAL PRODUCT GUIDANCE :Introduction -1 This guidance explains JFDA general recommendations and procedures that are applicable to the authorization of the emergency use of certain medical products to sustain and strengthen national preparedness and response for public health emergencies including emerging infectious disease threats such as to foster development and availability of ,also ,pandemic influenza .medical product for the use in these emergencies .Medical products include drugs and biological products is responsible for the determination of (MOH) Ministry of Health public health emergency or the potential for a public health emergency that has actual or potential effects on the national health .security JFD may authorize ,After pandemic circumstances declared by MOH the emergency use of an unapproved product or unapproved use for .provided that other statutory criteria are met ,an approved product This guidance allows JFDA to facilitate as well as permit the use of -or prevent life ,treat ,medical products in emergencies to diagnose ,threatening diseases or conditions when there are no adequate .and available alternatives ,approved This will enable different stockholders such as governmental to (hospitals) health entities ,pharmaceutical companies ,sponsors and participate ,collaborate ,be prepared for potential emergencies .in supporting public health during pandemic circumstances :Scope of this guidance -2 JFDA unapproved medical products including drugs and biological -1 .products JFDA unapproved use for approved medical products medical -2 products including drugs and biological products :Criteria for Issuance -3 JFDA may issue EUA only if JFDA concludes that the following four .statutory criteria for issuance have been met threatening disease or condition-Serious or life -1 Evidence of effectiveness -2 For medical products that might be considered for EUA are those threatening-and prevent life ,treat ,to diagnose ”may be effective“ may be ”The provided evidence for the EUA .conditions or diseases is with a lower level than the evidence required for the ”effective .standard used by the JFDA for regular product approval ”effective“ The potential effectiveness of a possible EUA product is intended to -case assessment using risk-by-be assessed by JFDA based on case JFDA may authorize the emergency use of the .benefit analysis product based on the totality of the available scientific evidence that made it reasonable to believe that the product may be effective for .that specific use benefit analysis-Risk -3 A product may be considered for an EUA if JFDA determines that the ,when used to diagnose ,known and potential benefit of the product outweigh the ,or treat the identified disease or condition ,prevent .known and potential risks for that product JFDA intends to look at the totality of the available scientific evidence to evaluate whether the ,benefit assessment-to make an overall risk known and potential benefits outweigh the known and potential ,which could come from a variety of sources ,These evidence .risks foreign (or)/(and) results of domestic :(but not limited to) may include and in vitro data that are available ,in vivo efficacy data ,clinical trials .for JFDA consideration taking ,The quality of the available evidence will be assessed by JFDA The type .into consideration the current state of scientific knowledge of scientific evidence that JFDA may consider and should be Section" submitted to support the EUA request is discussed deeply in .in this guidance "EUA Request :5 No alternatives -4 and ,approved ,For EUA issuance by JFDA there must be no adequate ,available alternative to the candidate product for diagnosing .(s)or condition (s)or treating the emergent disease ,preventing are insufficient supplies to (s)If the potential approved alternative may be (s)fully meet the emergency needs such alternative And could be considered as .’unavailable‘ considered as a dosage form of an approved product ,for example … [تتمة المادة في النص الرسمي]