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GMP and Personalized Medicine

No. 18/2012 - June 2012

Dear Colleagues,

summertime is coming and a lot of people will go on vacation. And we put together our first aid kit with different important personal drugs. Recently I followed some interesting presentations at the PDA annual meeting about personalized medicines. It will take a long time until we will have personalized medicine in our first aid kits. Nevertheless it is a really thriving topic in the pharma sector. Read in our feature today what the FDA has to say.

I am sure you know already that France has founded the new agency ANSM as successor of AFSSAPS (see the GMP news below).

Thomas Peither



GMP and Personalized Medicine

  • What is the current view of FDA on the GMP requirements for personalized medicines?
  • Do the current regulations cover ATMP sufficiently?
  • What are the challenges for GMPs in this sector?

Learn more about this fascinating topic in our feature today: "GMP and Personalized Medicine"


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GMP News

Foundation of a new French Health Regulation Authority

On 1 May 2012, the new "National Drug and Health Products Safety Agency / Agence nationale de sécurité du médicament et des produits de santé" (ANSM) was found.

Read more ...


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