Global Medtech Guidance Tracker: April 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty documents have been posted on the tracker since its last update.
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The UK MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.
Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.
The digitalization of clinical trials is generating more patient safety data than companies can process. A senior EMA official says sponsors should carefully select what is needed to maintain appropriate subject oversight by “getting the science right.”