Blog Articles

/Blog Articles
23 06, 2015

Implementation of academic ATMP in clinical practice in The Netherlands

By | June 23rd, 2015|Blog Articles|0 Comments

Advanced Therapy Medicinal Products (ATMPs), including gene (GTMP), cell (CTMP) and tissue-engineered products (TEP) can only be applied under European regulatory framework within: • A clinical study protocol • Hospital Exemption (HE) • Marketing Authorization (MA) [...]

1 07, 2014

Update and Request for Comments: Reflection Paper on the Classification of ATMPs

By | July 1st, 2014|Blog Articles|0 Comments

The EMA Expert Committee on ATMPs, CAT, has issued a new version of their reflection paper on ATMPs, updating the document to reflect the current thinking of the CAT on [...]

24 06, 2014

Topic of the Month: “EC Report on EU Regulation”. Please give your opinion!

By | June 24th, 2014|Blog Articles|0 Comments

Stakeholders to comment on the European Commission’s Report: The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (“ATMP [...]