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clinicalmedicineNon-ClinicalQualityRegulatory AdviceScientific AdviceEMA Medicine finder helps find information on medicines authorised for human or veterinary use. You can find these by including the medicine’s name or its active substance. It shows information on centrally authorised medicines – medicines that EMA evaluated.
View this resource Bookmark this resourceThe European Medicines Agency’s (EMA) Emergency Task Force (ETF) provides scientific advice to developers of medicines used in declared or potential public health emergencies and threats.
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Orphan DrugRegulatory ScienceThis paper describes the current status of the regulation of rare diseases and orphan drugs in Asia and we comparatively analyze the regulation of rare diseases and orphan drugs worldwide in order to examine the challenges to and future perspectives on promoting research on rare diseases and development of orphan drugs in China and other Asian countries.
View this resource Bookmark this resourceThe BrIDGs program assists researchers in advancing promising therapeutic agents through late-stage preclinical development toward an Investigational New Drug application and clinical testing.
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Drug Development AdviceEarly Access SupportRegulatory AdviceRegulatory AffairsScientific AdviceTargeted Engagement for Regulatory AdviceThrough a CBER Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/Toxicology, and/or clinical aspects of the development program
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Clinical TrialCommunity EngagementEarly Access SupportEarly Stage InteractionPatient AdviceProfessional AffairsRegulatory AdviceRegulatory AffairsScientific AdviceInteraction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)
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Early Access SupportMHLW or PMDA RegulatoryRegulatory AffairsScientific AdviceThe objective of the Study Group is to evaluate medical need, investigate necessary studies for market approval, and request company to develop medicinal products to solve the problem of unapproved drug and off- label use with medical need. Public consultations are conducted to gather requests from public.
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Advisory CommiteeApproval Advisory CommitteeEarly Access SupportRegulatory AffairsScientific AdviceTechnical AdviceAdvisory committees (AC) provide independent advice and recommendations the US FDA on scientific and technical matters related to the development and evaluation of products regulated by the FDA
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Early Access SupportProduct Development ProgrammeRegulatory AffairsScientific AdviceType A MeetingType C Meeting“Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important Safety issue
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Early Access SupportEnd of Phase 2 MeetingMilestone MeetingPre-NDA MeetingRegulatory AdviceRegulatory AffairsScientific AdviceThe default drug development program includes three milestones, or Type B meetings. The earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2) Meeting, and the third milestone is the Pre-NDA Meeting.
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