Published by
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.
View this resource Bookmark this resourcePublished by
Clinical DevelopmentClinical Trial DesignGuidelineRegulatory AdviceRegulatory AffairsThe European Medicines Agency’s Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.
View this resource Bookmark this resourceThe European Medicines Agency (EMA) provides regulatory and scientific support to help acadmeics develop medicines
View this resource Bookmark this resourceThe guidance outlines the main steps to take in preparation for submission and a list of documents required for the main1 types of paediatric submissions
View this resource Bookmark this resourcePublished by EPTRI
Drug DevelopmentpaediatricRegulatory Affairsresearch infrastructureTranslational ResearchThe EPTRI Centralised Services are provided by the EPTRI CMO and dedicated experts. These services include:
*Providing access to paediatric patients’ cohorts
*Providing access to paediatric samples and related data
*Advice on in-vivo / in-silico non-clinical study design
*Advice on in-vivo / in-silico clinical study design
*Advice and document preparation for regulatory and ethics procedures
*Advice on preparing HTA reports for paediatric medicines, diagnostics, and medical devices
*Advice on data and sample sharing preparation
*Support with applications to public and private funding opportunities
Published by IACMHR Co., Ltd.
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.
View this resource Bookmark this resourcePublished by IRDiRC
Early Access SupportHumanitarian Use DeviceMedical DeviceRegulatory SciencesSafe Medical Devices Actthe Safe Medical Devices Act to create a new regulatory pathway for device products intended for diseases or condition that affect small (rare) populations that defined HDEs and HUDs.
View this resource Bookmark this resourcePublished by IRDiRC
Early Access SupportJoInternationalEMA-FDA Scientific AdviceRegulatory SciencesScientific AdviceThe European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).
View this resource Bookmark this resource