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 …
The EU Commission has now published the second corrigendum to the MDR and the second corrigendum to the IVDR in the Official Journal of the EU (OJEU). The key change to the MDR states that devices classified as Class I under the MDD can continue to be placed on the market until the 26 May 2024 if the following conditions are met: The …
Due to the possibility of a no-deal brexit, the UK MHRA have released detailed guidance on a varity of topics. These are all collated into the “MHRA guidance and publications about a possible no-deal Brexit” On the 7th and 8th of August the HMRA added 10 new guidances which are listed below: Further guidance note on the regulation of medicines, …
The U.S. FDA has announced the availability of a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” This describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it provides an overview of the types of clinical studies that sponsors may perform and data sources they may use during …
The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) signed a Memorandum of Understanding (MoU) between the two parties in Washington D.C. on Friday 26 July 2019. The agreement will enable improved collaboration and knowledge sharing between the BP and the USP in a wide area of standards setting for medicines. One of the features of this agreement is the …