What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
EMA’s advice on managing the impact of the war in Ukraine
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
Spain: AEPD Approves 1st Industry Code of Conduct to Enable Compliance with the GDPR
The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the General Data Protection Regulation (GDPR). The CoC has been promoted by Farmaindustria (the National Business Association of the Pharmaceutical Industry) and [...]
US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes
The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]
UK: MHRA published guidance on clinical trial risk assessment, oversight and monitoring activities.
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring [...]
New FDA guidance: Good ANDA Submission Practices
The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices. "This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, [...]
Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022. Find out: ✔ how to report serious breach ✔ responsibilities of the different parties involved in the notification ✔ examples [...]
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
New guideline for Europe on trial changes has been published! MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation. The sponsor of a clinical investigation is required to submit an application to the Member State in [...]
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
