Global Pharma Guidance Tracker – April 2023
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient
The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.
EMA Looks For Efficiencies For Companies Ahead Of Relaunching Clinical Data Transparency Policy
Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.
Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data
EU regulators explain how sponsors who are running integrated Phase I/Phase II trials can overcome default transparency settings in the Clinical Trials Information System to protect the disclosure of dosing details if these contain commercially confidential information.