GMP for ATMP - European Commission adopts new Guideline
On 22 November, the European Commission adopted the expected new "Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products" as the new stand alone document for the current requirements for authorised ATMP as well as for clinical trials.
Become an active part of the Conference "Particles in Parenterals"
The ECA Foundation's Visual Inspection Interest Group has been conducting the annual conference "Particles in Parenterals" for several years now. For the planning of the 2018 event you can become involved as an active part.
EDQM publishes Guidance for root-cause Analysis of non-satisfactory external Quality Assessment Results
The European Directory for the Quality of Medicines and Healthcare Products (EDQM) published a guidance document on the handling and root-cause analysis of Non-Conformity results in quality assessments.
Guideline for Medicinal Products containing genetically modified Cells - EMA plans Revision
The European Medicines Agency (EMA) proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells and published an corresponding concept paper incuding the current scientific developments.
Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells
The US FDA published Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient.
GMP for ATMP - two Public Rounds of consultation and still a Need for Discussion?
After the second public consultation for the EMA Guideline on GMP for Advanced Therapy Medicinal Products there are still uncertainties and a persisting need for discussion of the current regulatory requirements.