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MHRA issues guidance on post-market surveillance regulation in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation
Industry news
FDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
ICH releases M15 Guideline on Model-informed Drug Development
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.
EC announces evaluation of medical device and IVD regulations
The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Use of new EMA platform for monitoring medicine shortages to become mandatory
The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs).
More news
Greater post-market surveillance for medical devices
FDA proposes to remove oral phenylephrine in selected drugs
New cancer drug approved by MHRA
New guidance for wholesalers and manufacturers following Windsor Framework
WHO Pandemic Agreement gains signatories
Regulators publish new guidelines for use of AI
New Editor-in-Chief for Regulatory Rapporteur