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![USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format](https://static.wixstatic.com/media/6516fb_0c55d0e8270941f7b081e18bdb46d507~mv2.jpg/v1/fill/w_349,h_256,fp_0.50_0.50,q_90,enc_auto/6516fb_0c55d0e8270941f7b081e18bdb46d507~mv2.jpg)
Sharan Murugan
- Jun 26, 2022
- 1 min
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...
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![SFDA's Guidance on Data Requirements for the Renewal of Marketing Authorizations Drug Products](https://static.wixstatic.com/media/nsplsh_33526e32456a6f41433167~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_33526e32456a6f41433167~mv2.jpg)
Sharan Murugan
- Jun 26, 2022
- 1 min
SFDA's Guidance on Data Requirements for the Renewal of Marketing Authorizations Drug Products
This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with...
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![India MoH's - Draft Proposal for adding QR Codes for important SCHEDULE H2 Drugs](https://static.wixstatic.com/media/6516fb_3f04cc4ea86d41d59ac54d55f51aa603~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_3f04cc4ea86d41d59ac54d55f51aa603~mv2.jpg)
Sharan Murugan
- Jun 24, 2022
- 1 min
India MoH's - Draft Proposal for adding QR Codes for important SCHEDULE H2 Drugs
India's Ministry of Health and Human Welfare has released a draft proposal on 14th June, 2022 which suggests to add barcodes or quick...
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![South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction](https://static.wixstatic.com/media/6516fb_6d07a85c4b0e4ee084719a354d483544~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_6d07a85c4b0e4ee084719a354d483544~mv2.jpg)
Sharan Murugan
- Jun 18, 2022
- 1 min
South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction
The South African Health Products Regulatory Authority (SAPHRA) did a few Administrative updates and amendments in its Post-marketing...
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![Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration](https://static.wixstatic.com/media/6516fb_37ce9e13afe6449b9bc53099d4e06ac5~mv2.jpg/v1/fill/w_399,h_232,fp_0.50_0.50,q_90,enc_auto/6516fb_37ce9e13afe6449b9bc53099d4e06ac5~mv2.jpg)
Sharan Murugan
- Jun 18, 2022
- 1 min
Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration
Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...
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