EMA Submission

Auxillis, in cooperation with strategic partner Kinderpharm, can assist clients in the preparation of a paediatric investigation plan (PIP) according to the current EMA requirements and specifications.  The paediatric investigation plan (PIP) will be prepared according to the content and format of the current EMA Regulations.

  • Regulation (EC) No 1901/2006 of the European Parliament and the Council of 12 December 20016 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Direction 2001/83/EC and Regulation (ED) No 726/2004 (27 December 2006)
  • Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies (27 September 2014)
  • Concept paper on extrapolation of efficacy and safety in medicine development (19 March 2013)

 

FDA Submission

Auxiliis and Kinderpharm may also assist clients in the preparation of an paediatric study plan (PSP) according to the current FDA requirements and specifications under PREA.

The paediatric study plan (iPSP) will be prepared according to the content and format of the current FDA Guidance for Industry:

  • Paediatric Study Plans: Content of and Process for Submitting Initial Paediatric Study Plans and Amended Paediatric Study Plans (July 2013)
  • E11 Clinical Investigation of Medicinal Products in the Paediatric Population (December 2000)
  • How to Comply with the Paediatric Research Equity Act (September 2005)
  • General Clinical Pharmacology Considerations for Paediatric Studies for Drugs and Biological Products (December 2014)