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MHRA Guidance: Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has established comprehensive guidelines detailing the " Format and...

Sharan Murugan
Feb 282 min read
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UK MHRA Guidance: 150-Day Assessment for National Applications for Medicines & Procedures for UK Paediatric Investigation Plans (PIPs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) continues to innovate in the regulatory space with updated processes...

Sharan Murugan
Jan 22 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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EMA Guidance: Paediatric Submissions Via Syncplicity Web Client
Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....

Sharan Murugan
Jun 17, 20231 min read
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