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EMA: Detailed guidance on ICSRs in the context of COVID-19

This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission and the guidance regarding COVID-19 related terms published by the MedDRA MSSO. [...]

2020-04-26T17:41:52+00:0026.04.2020|Regulatory Affairs, Training|

EMA: Update to guidance on regulatory expectations in the context of COVID-19 pandemic

The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related [...]

2020-04-26T11:36:10+00:0026.04.2020|Regulatory Affairs, Training|

EMA: Guidance on regulatory requirements in the context of the COVID-19 pandemic

The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. The current pandemic is a global public health emergency causing major disruptions that impact citizens, [...]

2020-04-12T16:15:29+00:0012.04.2020|Regulatory Affairs, Training|

EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) [...]

2020-03-31T22:37:57+00:0031.03.2020|Regulatory Affairs, Training|

FDA Guidance: Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.   Posted on the FDA website on 22 March 2020

2020-03-25T17:39:05+00:0025.03.2020|Regulatory Affairs, Training|

UK MHRA guidance on Coronavirus (COVID-19)

The MHRA is working closely with DHSC and other healthcare partners on COVID-19. We are prioritising work including: Supporting and authorising the development of vaccines Clinical trials of new medicines Managing the supply of medicines and healthcare products We also provide information to patients, manufacturers and healthcare professionals through our established information channels and alert systems. The [...]

EMA: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to [...]

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic. FDA is issuing this guidance to provide general considerations [...]

FDA Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.  We, FDA, are providing you, sponsors of human gene therapy Investigational New Drug Applications (INDs), recommendations regarding chemistry, manufacturing, and control (CMC) information submitted in an IND.  The purpose of [...]

2020-02-04T21:07:00+00:0004.02.2020|Regulatory Affairs, Training|

FDA Guidance for Industry: Human Gene Therapy for Hemophilia

This guidance provides recommendations to sponsors developing human gene therapy (GT) products for the treatment of hemophilia including clinical trial design and related development of coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in factor VIII and factor IX activity assays.  This guidance also includes recommendations regarding [...]

FDA Guidance for Industry: Human Gene Therapy for Rare Diseases

This guidance provides recommendations to sponsors developing human gene therapy (GT)  products intended to treat a rare disease  in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program.  Such information is intended to assist sponsors in designing clinical development programs for such products, [...]

FDA Guidance for Industry: Human Gene Therapy for Retinal Disorders

This guidance provides recommendations to sponsors developing human gene therapy (GT)  products for retinal disorders affecting adult and pediatric patients.  These disorders vary in etiology, prevalence, diagnosis, and management, and include genetic as well as age-related diseases.  These disorders manifest with central or peripheral visual impairment and often with progressive visual loss.  This guidance focuses [...]

FDA Guidance for Industry: Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions

The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, [...]

2019-12-30T17:30:35+00:0030.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review

This technical specifications document provides you, sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.  We, FDA, recommend [...]

2019-12-30T17:25:47+00:0030.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics

This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes important principles for designing, [...]

2019-12-07T11:23:08+00:0007.12.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

The purpose of this guidance is to help sponsors design and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, this guidance describes the Food and Drug Administration’s (FDA’s) current thinking about the substance and scope of nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and marketing [...]

2019-10-10T22:16:47+00:0010.10.2019|Regulatory Affairs, Training|

FDA Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such [...]

2019-10-03T21:27:05+00:0003.10.2019|Regulatory Affairs, Training|

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]