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Sharan Murugan
- Dec 5, 2021
- 2 min
Guidance on QPPV including Pharmacovigilance System Master Files– MHRA
UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on requesting a pharmacovigilance system master file...
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Sharan Murugan
- Nov 30, 2021
- 1 min
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...
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Sharan Murugan
- Nov 28, 2021
- 2 min
Guidance for Declaration of Conformity - TGA
When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different...
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Sharan Murugan
- Nov 20, 2021
- 1 min
MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK
This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...
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Sharan Murugan
- Nov 14, 2021
- 1 min
Pharmaceutical Reference Standard – Guidance Update - SFDA
Standards and reference substances play a vital role in evaluating the quality of active pharmaceutical ingredients and finished...
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