In an update to the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on good clinical practices (GCPs), definitions for the inspection outcome terms “critical,” “major” and “other” have been provided. Read more “MHRA updates GCP guidance to define inspection findings”
News
Regulis is shortlisted for two TOPRA Regulatory Excellence Awards
For the second time in the last two years, we are delighted to have been shortlisted for not one but TWO TOPRA Regulatory Excellence Awards. Read more “Regulis is shortlisted for two TOPRA Regulatory Excellence Awards”
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”
FDA releases draft guidance for post-approval changes to drug substances
The US Food and Drug Administration (FDA) have released new draft guidance for drug manufacturers who are looking to make a change to the drug substance manufacturing process during an application’s post-approval period. Read more “FDA releases draft guidance for post-approval changes to drug substances”
FDA release draft guidance on the uncertainty of medical device benefit-risk determinations
The US Food and Drug Administration (FDA) have released draft guidance regarding acceptable levels of uncertainty when it comes to the risk-benefit balance of medical devices.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”
First CAR-T therapies approved by European regulators
The first chimeric antigen receptor T-cell therapies (CAR-T), named Kymriah and Yescarta, have been approved by European regulators, enabling patients to access CAR-T therapies for the first time. Read more “First CAR-T therapies approved by European regulators”
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”