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![Swiss Medic: Guidance on Transfer of Marketing Authorisation](https://static.wixstatic.com/media/nsplsh_d615b4690010441ca65aa075324e8783~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_d615b4690010441ca65aa075324e8783~mv2.jpg)
Sharan Murugan
- May 7, 2023
- 1 min
Swiss Medic: Guidance on Transfer of Marketing Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...
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![EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS](https://static.wixstatic.com/media/6516fb_d046ce96e3ff435e81b49d302bdac91a~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_d046ce96e3ff435e81b49d302bdac91a~mv2.jpg)
Sharan Murugan
- May 7, 2023
- 2 min
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...
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![USFDA Guidance: Assessing User Fees Under the PDUFA of 2022](https://static.wixstatic.com/media/nsplsh_da726c04569f4e1488bd2c835a2b911f~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_da726c04569f4e1488bd2c835a2b911f~mv2.jpg)
Sharan Murugan
- May 4, 2023
- 1 min
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022
This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
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![ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management](https://static.wixstatic.com/media/6516fb_1aa5ba9c977349c1a412a73dd0f8e85e~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_1aa5ba9c977349c1a412a73dd0f8e85e~mv2.jpg)
Sharan Murugan
- May 4, 2023
- 1 min
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
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![Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD](https://static.wixstatic.com/media/nsplsh_17393fc587d04dbdb0071c7db107a505~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_17393fc587d04dbdb0071c7db107a505~mv2.jpg)
Sharan Murugan
- May 4, 2023
- 1 min
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...
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