Advice for investigators and sponsors of ongoing clinical investigations and new applications.
We are producing guidance and information for industry, healthcare professionals and patients covering the coronavirus (COVID-19) outbreak. 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 Read more here
As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in PDF iconthe inventory can accelerate every step of a medicine’s regulatory pathway …
In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation …
Overview Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China. It was initially reported to the World Health Organization (WHO) on December 31, 2019. On January 30, …
The Medical Device Coordination Working Group (MDCG) on Clinical Investigation and Evaluation has developed guidance to assist with some of the key clinical requirements outlined in the Medical Device Regulation (MDR). The documents are as follows: PMCF Evaluation Report Template Guidance on PMCF Plan Template Guidance on Sufficient Clinical Evidence for Legacy Devices Guidance on Clinical Evaluation – Equivalence The …
Today, the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is announcing the establishment of the Newly Identified Safety Signal (NISS) process and the posting of its associated manual of policies and procedures (MAPP) 4121.3, Collaborative Identification, Evaluation, and Resolution of a NISS. FDA makes MAPPs publicly available as part of its transparency …
This document provides guidance on applying to the HPRA for a new manufacturer’s authorisation or to vary an existing manufacturer’s authorisation. This guide should be read in conjunction with other stated forms. A number of sections of the Manufacturing and Importation Authorisation (MIA) have been described, such as the applicant details and the content of the appendices. These three appendixes …
EMA ICH M9 on biopharmaceutics classification system based biowaivers https://www.ema.europa.eu/en/ich-m9-biopharmaceutics-classification-system-based-biowaivers Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated) https://www.espl-regulatory.com/wp-content/uploads/attachments/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0-8.pdf Quality of medicines questions and answers: Part 1 (updated) https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/qa-quality/quality-medicines-questions-answers-part-1 Other: European authorities working to avoid shortages of medicines due to Brexit – Questions and answers (updated) https://www.espl-regulatory.com/wp-content/uploads/attachments/european-authorities-working-avoid-shortages-medicines-due-brexit-questions-answers_en-9.pdf ECA Falsified Medicines: …
This is the list of guidance topics CBER is considering for development during Calendar Year 2020. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft guidances that may be finalized following review of public comments. Click Here for the …