GMP News - Blood / Biologics and ATMP

16.10.18

Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing

FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".

16.10.18

Revision: FDA Guideline on Adaptive Designs for Clinical Trials

In September, the US Food and Drug Administartion published a draft guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics. It is the revision of the existing guidance from 2010.

16.10.18

FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.

09.08.18

GCP for ATMP - Stakeholder Consultation on the Draft Guideline

The European Medicines Agency had announced a guideline on GCP for ATMPs. Now, the Draft Guideline on Good Clinical Practice for Advanced Therapy Medicinal Products has been published and is open for targeted stakeholder consultation unti end of October.

09.08.18

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.

09.08.18

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".

08.03.18

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.

08.03.18

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.

08.03.18

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".

20.02.18

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.

20.02.18

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.

20.02.18

FDA publishes Draft Guideline on Use of Nanotechnologies for Biological Medicinal Products

The FDA expands their guidelines regarding the use of nanotechnologies with a draft on the topic "Drug Products, Including Biological Products, that Contain Nanomaterials".

31.01.18

WHO publishes Guideline on Worker Safety relating to Nanomaterials

Relating to the increasing use of nanomaterials in manufacturing and the possible following risks for manufacturing staff the WHO issued a new guideline document entitled "WHO guidelines on protecting workers from potential risks of manufactured nanomaterials" .

12.12.17

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.

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.

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GMP News - Blood / Biologics and ATMP

Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing

Revision: FDA Guideline on Adaptive Designs for Clinical Trials

FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics

GCP for ATMP - Stakeholder Consultation on the Draft Guideline

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

European Commission publishes revised Version of EU GMP Guideline Annex 2

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

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

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

FDA Draft Guideline on reporting Changes to an approved Application

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

FDA publishes Draft Guideline on Use of Nanotechnologies for Biological Medicinal Products

WHO publishes Guideline on Worker Safety relating to Nanomaterials

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

EMA publishes first Guidance for Stem Cell Therapies in Animals

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Contamination Control Strategies Requirements, Measures and Strategies

GMP News - Blood / Biologics and ATMP

Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing

Revision: FDA Guideline on Adaptive Designs for Clinical Trials

FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics

GCP for ATMP - Stakeholder Consultation on the Draft Guideline

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

European Commission publishes revised Version of EU GMP Guideline Annex 2

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

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

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

FDA Draft Guideline on reporting Changes to an approved Application

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

FDA publishes Draft Guideline on Use of Nanotechnologies for Biological Medicinal Products

WHO publishes Guideline on Worker Safety relating to Nanomaterials

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

EMA publishes first Guidance for Stem Cell Therapies in Animals

Recommended Event

Contamination Control Strategies Requirements, Measures and Strategies

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