In Brexit Transition UK MHRA Escape as ‘Leading Authority’ for Drugs

UK MHRA will not act as ‘leading authority’ for medicines during the Brexit transaction period as per Article 123 of the draft Withdrawal Agreement. In which UK MHRA will not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States. (more…)

COVID-19 Related Guidance Immediately Implementing Without Public Comment by FDA

FDA to implement all COVID-19 related guidance immediately, without public comment. But will open for public comment after implementation and FDA said it will still solicit comment, review all comments received and revise the guidance documents as appropriate. (more…)

FDA Released Clinical Trials Guidance for Medical Products Impacted by COVID-19

The FDA issued new guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. (more…)

Implementation of Clinical Trials Regulatory Activities in eCTD Format Begins by Health Canada

After successful Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format in the pilot in August 2019, Health Canada begins implementation of Clinical Trials regulatory activities in eCTD format. (more…)

FDA’s eCTDv4.0 Technical Conformance Guide: Open for Comments

The FDA has finalized guidance documents on eCTD submission format for eCTDv4.0 Technical Conformance Guidance and the FDA eCTDv4.0 Module 1 Implementation Package. (more…)