03/14/2023
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High risk medical device manufacturers now have until the end of 2027 and low to medium risk medical device manufacturers have until the end of 2028 to comply with certification requirements.
Medical Device Regulation Transition Extension Adopted
02/28/2023
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On February 16, 2023, the European Parliament voted to adopt the European Commission’ proposal to extend the MDR transition period and to extend some device certificates.
EMA FAQ for GMP Updated
02/14/2023
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The European Medicines Agency (EMA) Good Manufacturing Practice Frequently Asked Questions (FAQ) webpage offers guidance on good manufacturing practice (GMP) and good distribution practice (GDP). Previous revisions in February and October 2022 were relating to veterinary medicinal products.
Updated EMA GCP FAQ Guidance: CRO Oversight
02/07/2023
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The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. Several of the questions were previously revised in March 2022.
Under section “GCP matters”, questions 16 and 17 were added in late 2022. Question 16 was covered in an earlier blog HERE.
CTIS Required for New Clinical Trial Applications
01/30/2023
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Beginning January 31, 2023, the Clinical Trials Information System (CTIS) is required for all new clinical trial applications that are applicable to the European Medicines Agency (EMA). The Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) entered into application January 31, 2022, which also launched the CTIS.