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Sharan Murugan
- Apr 20
- 2 min
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...
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Sharan Murugan
- Apr 20
- 2 min
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
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Sharan Murugan
- Apr 16
- 2 min
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...
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Sharan Murugan
- Apr 16
- 2 min
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
Earlier today (16 April 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on "Rolling Review for...
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Sharan Murugan
- Apr 13
- 2 min
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
Yesterday (12 April 2024) the European Medicines Agency released new guidance on "The Pharmaceutical Quality of Inhalation & Nasal...
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