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SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA)Â has released an updated " Guideline for the Classification of Medical...
Sharan Murugan
Feb 282 min read
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EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs
The European Medicines Agency (EMA)Â has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...
Sharan Murugan
Feb 282 min read
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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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EMA Addendum: Clinical Development of Vaccines in Immunocompromised Individuals
The European Medicines Agency (EMA) has released an addendum to its Guideline on the " Clinical Development of Vaccines to address the...
Sharan Murugan
Feb 272 min read
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EMA Concept Paper: Guideline on Mechanistic Models in Model-Informed Drug Development (MIDD)
The European Medicines Agency (EMA) has released a concept paper  proposing the development of a guideline for the assessment and...
Sharan Murugan
Feb 222 min read
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