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![Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval](https://static.wixstatic.com/media/6516fb_04a72398db1046b3b73a183cd844c294~mv2.png/v1/fill/w_399,h_300,fp_0.50_0.50,q_95,enc_auto/6516fb_04a72398db1046b3b73a183cd844c294~mv2.png)
Sharan Murugan
- 5 days ago
- 2 min
Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval
The Saudi Food & Drug Authority (SFDA) has released updated guidance on "Regulatory Framework for Drugs Approval". This comprehensive...
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![](https://static.wixstatic.com/media/nsplsh_0ab21c35941746dfb1b5242910d2a358~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_0ab21c35941746dfb1b5242910d2a358~mv2.jpg)
![EMA Guidance: Proposed Amendments - Variations Categories and Procedures](https://static.wixstatic.com/media/nsplsh_0ab21c35941746dfb1b5242910d2a358~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_0ab21c35941746dfb1b5242910d2a358~mv2.jpg)
Sharan Murugan
- Jun 15
- 2 min
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...
36 views0 comments
![](https://static.wixstatic.com/media/nsplsh_6d31487134696250397263~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_6d31487134696250397263~mv2.jpg)
![Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation](https://static.wixstatic.com/media/nsplsh_6d31487134696250397263~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_6d31487134696250397263~mv2.jpg)
Sharan Murugan
- Jun 9
- 2 min
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...
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![UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation](https://static.wixstatic.com/media/6516fb_cd862365f3374ca1a41f1b1ec9182bad~mv2.png/v1/fill/w_399,h_300,fp_0.50_0.50,q_95,enc_auto/6516fb_cd862365f3374ca1a41f1b1ec9182bad~mv2.png)
Sharan Murugan
- Apr 22
- 2 min
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...
55 views0 comments
![](https://static.wixstatic.com/media/nsplsh_3650334f705144624c3359~mv2.jpg/v1/fill/w_250,h_250,fp_0.50_0.50,q_30,blur_30,enc_auto/nsplsh_3650334f705144624c3359~mv2.jpg)
![Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway](https://static.wixstatic.com/media/nsplsh_3650334f705144624c3359~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_3650334f705144624c3359~mv2.jpg)
Sharan Murugan
- Feb 7
- 2 min
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...
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