Bioequivalence and Bioavailability Forum

Dear all,

today the EMA published the “Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice”. End of consultation is on 31 August 2018.

Have also a look at the applicable guidelines on Good Distribution Practice (GDP):

• Guideline 2013/C 343/01
  
• Guideline 2015/C 95/01
  
• Q&A document