GMP News - Blood / Biologics and ATMP

18.02.13

Risk-based Approach to Advanced Therapy Medicinal Products

In 2012, the EMA Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products was open for comments. The risk-based approach is based on the identification of various risks associated with the clinical use of an ATMP and risk factors inherent to the ATMP with respect to quality, safety and efficacy. To learn more about this, click here.

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18.02.13

Warning on transmissible Agents

When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. The "Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products" updates the previous recommendations and states the warning to be included in the SmPC and Package Leaflet of any plasma-derived medicinal product. More details can be found here.

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18.02.13

Isolation of Candidate Influenza Vaccine Viruses in Cell Culture

In Febraury 2012 EMA's "Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture" became official. The scope of this document is to provide guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine manufacture. More details can be found here.

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18.02.13

Recombinant and Human Plasma-derived Factor IX Products

In February 2012 the "Guideline on clinical investigation of recombinant and human plasma-derived factor IX products" came into effect. The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor IX products. More can be found here.

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18.02.13

Recombinant and Human Plasma-derived Factor VIII Products

The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor VIII products. Find out more.

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18.02.13

Plasma-derived Medicinal Products

Providing guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products the "Guideline on plasma-derived medicinal products" became effective in 2012. Read on here.

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