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EMA Guidance: For stepwise PIPs (sPIPs)
Paediatric drug development remains one of the most complex regulatory areas in the pharmaceutical landscape. Scientific uncertainty, evolving clinical insights, and gaps in early evidence often make it difficult for developers to design complete paediatric programmes at the initial stages of development. Recognising these challenges, the European Medicines Agency (EMA) has introduced a specialised mechanism known as the stepwise Paediatric Investigation Plan (sPIP) , formall
Sharan Murugan
Nov 29, 20253 min read
EMA Guidance: Procedural Advice on Paediatric Applications
On 25 July 2025 , the European Medicines Agency (EMA) published the latest guidance " Procedural Advice on Paediatric Applications " ....
Sharan Murugan
Jul 31, 20252 min read
EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) has issued updated guidance " Procedural advice on Paediatric Applications " to support stakeholders...
Sharan Murugan
Apr 18, 20253 min read
MHRA Guidance: Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan
The Medicines and Healthcare products Regulatory Agency (MHRA) has established comprehensive guidelines detailing the " Format and...
Sharan Murugan
Feb 28, 20252 min read
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 2, 20252 min read
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