PDE Implementation deadlines

The Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities EMA/CHMP/CVMP/SWP/169430/2012, which is supported by the Questions and answers EMA/CHMP/CVMP/SWP/246844/2018, and the Overview of comments EMA/CHMP/SWP/364535/2015 documents was implemented:

1st December 2015

For medicinal products introduced for the first time into shared manufacturing facilities.

1st June 2016

For manufacturers of products for human use already produced in shared manufacturing facilities (unless existing arrangements scientifically justified) including those who manufacture human and veterinary medicines using shared manufacturing facilities.

1st June 2017

For manufacturers solely producing products for veterinary use (unless existing arrangements scientifically justified).


To fulfil guidelines on shared facilities requirements within the deadlines imposed, we elaborate some customized PDE monographs for all concerned products.

Access directly to our database which contains more than 1,300 PDE monographs already developed.


You can check ToxBy.Design methodology for PDE Monograph, which are duly validated and signed by an European Registered Toxicologist expert.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that ToxBy.Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using the Quotation Request below to receive a quotation for PDE Monograph for your Active Pharmaceutical Ingredient, New Chemical or Biological Entity or any Chemicals substances deployed in your GMP manufacturing lines.