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The increasing Importance of Gene Therapies - FDA Statement and New Guidelines

The increasing importance of Gene Therapy becomes obvious when you take a look at the increasing focus of the competent authorities - as, for example, the current FDA's six new guidance documents on Gene Therapies show.

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European Commission publishes revised Version of EU GMP Guideline Annex 2

As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".

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EMA Committee for Advanced Therapies (CAT) publishes 2018 Work Plan

Concerning their activities in the field of ATMP, the EMA Committee for ATMP (CAT) published their work plan for 2018 for the different areas of responsibility from pre-authorisation to used technologies.

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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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