EMA To Coordinate GMP Inspections Via Online Portal
The EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.
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The new portal is expected to provide an improved method for applying for and managing EU orphan drug designations.
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.
The COVID-19 pandemic has given a new impetus to Sweden’s ongoing efforts to support decentralized clinical trials.