News

FDA proposes electronic submission for medical device market applicants

The US Food and Drug Administration (FDA) intends to remove requirements for paper and multiple copies of medical device premarket applications, and replace it with a single submission in electronic format. The new proposed rule would apply to: 510(k) premarket notifications; Investigational Device Exemptions (IDE); Premarket Approvals (PMA) applications and supplements; Humanitarian Device Exemptions (HDE) and applications to the Center for Biologics Evaluation and Research (CBER). Read more “FDA proposes electronic submission for medical device market applicants”

Health Canada launches pilot project on new meeting framework for pre-clinical advice on devices

Health Canada has launched a pilot project which aims to provide a new formal process for device companies seeking early advice. A formal pre-clinical process will allow manufacturers to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process. The aim is to facilitate effective communication between medical device manufacturers and Health Canada to improve the quality of submissions and provide timely regulatory decisions. Read more “Health Canada launches pilot project on new meeting framework for pre-clinical advice on devices”

EMA looks to improve the availability of medicines in the EU

The task force set up by European Union (EU) regulators, which aims to address potential problems with medicines’ supply and avoid shortages, has published their work programme for the next two years (2019/20). The work programme contains actions for regulators and the industry to ensure the availability of medicines for the benefit of patients in the EU. Read more “EMA looks to improve the availability of medicines in the EU”

Submitting regulatory information if there’s no Brexit deal

The Department of Health and Social Care has released guidance to inform Medicines and Healthcare products Regulatory Agency (MHRA) stakeholders of how to continue to submit regulatory information in the event of a ’no-deal’ Brexit scenario. Further guidance on ‘Batch testing medicines if there’s no Brexit deal’ and ‘How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal’ should also be considered. Read more “Submitting regulatory information if there’s no Brexit deal”

EMA releases simplified process for transferring internal marketing authorisations in response to Brexit

The European Medicines Agency (EMA) has released a simplified process for transferring marketing authorisations in response to Brexit. The process applies to companies that would like to move marketing authorisations between organisations registered under the same EudraVigilance (EV) headquarter profile. Read more “EMA releases simplified process for transferring internal marketing authorisations in response to Brexit”