The Australian Senate has extended until 2 September the reporting time for its inquiry into the how the granting of gene patents is impacting the healthcare system 1 . The inquiry, by the Senate's...
The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination...
The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination...
The Human Tissues Working Party of UK charity the Safer Medicines Trust believes that individuals on the organ donor register should be asked about the possibility of donating tissues that would be...
There will be a delay in the appointment of the new executive director at the European Medicines Agency , the European Commission has confirmed to RAJ Devices 1 . A commission spokesperson said: "It...
A somatic cell therapy for treating cardiovascular diseases has become the first product to obtain certification of experimental data by the European Medicines Agency under the European Union´s...
The European Medicines Agency’s Committee for Advanced Therapies is drafting guidance to explain how medical device notified bodies should interact with the EMA when evaluating advanced therapy...
The Committee for Advanced Therapies at the European Medicines Agency has officially adopted and published its reflection paper on in vitro culture chondrocyte containing products for cartilage...
Representatives from several European life sciences industry associations, including medtech group Eucomed, will meet with the European Medicines Agency’s Committee for Advanced Therapies later this...
The European Medicines Agency has adopted a document that explains an optional procedure under which sponsors can request a scientific recommendation from the agency’s Committee for Advanced...
The UK’s Medicines and Healthcare products Regulatory Agency has created a webpage for manufacturers and developers of advanced therapy medicinal products products 1 . The site includes explanations...
As the European Medicines Agency celebrates the 15th anniversary of its creation in January 1995, its Committee on Advanced Therapies has marked its first year of operations by reviewing progress in...
The European Medicines Agency intends to revise its guideline on gene therapy medicinal products dealing with quality, non-clinical and clinical aspects to address issues in this “rapidly developing...
The mutual recognition agreement between Switzerland and the European Union covering good manufacturing practice issues has been expanded to include advanced therapy medicinal products 1 ,2 . The...
UK stem cell scientists have been given what is being billed as a "regulatory road map" for the development of their work and its translation into the clinical setting. The "UK Stem Cell Tool Kit"...
