GMP News - Blood / Biologics and ATMP

12.12.17

EMA publishes first Guidance for Stem Cell Therapies in Animals

In June, the EMA published a new Q&A document on the sterility of allogenic stem cell therapies in the veterinary sector. It represents the first guidance document on this topic.

more

29.11.17

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.

more

29.11.17

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.

more

12.10.17

FDA Draft Guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products

In August, the FDA published a Draft Guidance for Industry on CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.

more

12.10.17

FDA publishes Biological Product and HCT/P Deviation Reports for Fiscal Year 2016

The US Food & Drug Administration (FDA) published a deviation report for Biological Products and HCT/P for Fiscal Year 2016, comparing the results with the two years before.

more

12.10.17

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. 

more

21.09.17

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.

more

21.09.17

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.

more

21.09.17

FDA Information about Human Cell and Tissue (HCT/P) related Inspections

The US Food & Drug Administration (FDA) published an overview about HCT/P inspections in the last five fiscal years.

more

21.09.17

EMA - New guide for healthcare professionals on biosimilar medicines

The European Medicines Agency (EMA), the European Commission and experts from the Member States issued a new Guide for Healthcare Professionals on Biosimilars.

more

16.03.17

PIC/S statement to European Commission's ATMP GMP Guideline

The PIC/S published a harsh letter to the European Commission relating to their draft guideline on GMP for Advanced Therapy Medicinal Products (ATMP).

more

16.03.17

Ongoing developments in the field of ATMP

Beginning of February, the European Medicines Agency (EMA) published new information about Advanced Therapy Medicines and how to get to an increased ATMP development and patient access.

more

09.02.17

FDA Guidance for Blood Donations with regard to Ebola Virus published

In January the FDA published a guidance for industry on "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".

more

09.02.17

FDA Draft Guidance on Labeling of Red Blood Cell Units with Historical Antigen Typing Results

On 17 January the US FDA published a draft guidance on "Labeling of Red Blood Cell Units with Historical Antigen Typing Results". It is now open for comments.

more

18.01.17

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.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics