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Swissmedic Guidance: Clinical Trials with Medicinal Products, Submission Process and FAQs
Clinical trials are the cornerstone of developing safe and effective medicines. In Switzerland, the regulatory authority...

Sharan Murugan
Aug 282 min read
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Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
Irelands Health Products Regulatory Authority (HPRA) released updated guidance on "Submitting a Request for Ireland to Act as RMS in a...

Sharan Murugan
Apr 7, 20242 min read
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USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan
Mar 31, 20242 min read
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MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Sharan Murugan
Jan 18, 20242 min read
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EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...

Sharan Murugan
Jan 13, 20241 min read
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USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
Earlier this week the the U.S. Food and Drug Administration (FDA)Â released multiple guidances that is related to Digital Technologies and...

Sharan Murugan
Dec 27, 20232 min read
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Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes
Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This...

Sharan Murugan
Aug 4, 20221 min read
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