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CAT and CHMP update their Procedural Advice on the Evaluation of ATMPs

Relating to the ongoing experiences in the marketing authorisation of ATMPs, the EMA published an updated version of their "Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".

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EMA releases Draft Guideline on Safety and Efficacy Follow-up and Risk Management of ATMPs

The European Medicines Agency (EMA) published the first revision on their Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products, considering the experiences since the first adopted version.

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FDA Draft Guideline on reporting Changes to an approved Application

At the end of last year, the FDA published a revision draft for their guideline "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products" which is supposed to take account of the current standards of risk assessment and the submitted data of past change notifications.

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FDA revises Guideline on HIV and HCV Testing for the Assessment of Blood Donors

With an update of their guideline on NAT testing of blood and plasma donations for HIV-1 and HCV, the FDA takes account of the developments regarding methods and related regulations.

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EMA publishes Concept Paper on Revision of the Guideline on Clinical Development of Vaccines

The EMA published a Concept Paper on the revision of the 10 years old guideline on clinical evaluation of vaccines, relating to the ongoing advancements in the field of vaccine development.

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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.

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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.

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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. 

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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.

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Guidance for Industry: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated  the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

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