GMP News - Blood / Biologics and ATMP

The US FDA has conducted retrospective analyses of data from a large health claims-related database as well as continued postmarketing adverse event reports of thrombosis. These analyses have strengthened the evidence for an association between the use of intravenous, subcutaneous, and intramuscular human immune globulin products and the risk of thrombosis. For that reason the authority now demands a boxed warning for the entire class of products. Read more.

In March 2013, the FDA published a draft guidance "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis". For more details read here.

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. This includes information related to starting and raw materials. The draft reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products i supposed to provide information on that topic. Read more here.

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.

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.