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Sharan Murugan
- 4 days ago
- 2 min
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...
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Sharan Murugan
- Mar 29
- 2 min
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....
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Sharan Murugan
- Jan 31
- 1 min
Australia TGA: eCTD AU module 1 and regional information
Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...
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Sharan Murugan
- Dec 11, 2023
- 1 min
Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
On 11th December 2023, Singapore's Health Sciences Authority (HSA) released an update "Post-Industry Consultation Updates on Electronic...
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Sharan Murugan
- Nov 30, 2023
- 1 min
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...
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