The Plasma Protein Therapeutics Association (PPTA) welcomes the newly revised position of the European Medicines Agency (EMA) on no longer classifying previous United Kingdom (UK) residence as a risk factor for variant Creutzfeldt-Jakob Disease (vCJD) when donating plasma to be used to make plasma-derived medicinal products (PDMPs).
In an updated statement, EMA stated that fractionation of plasma from potential donors who have spent a year or more (cumulatively) in the UK between 1980 and 1996 is "no longer considered to pose a health risk for recipients of plasma-derived medicinal products." This decision is made following an evaluation of clinical and epidemiological evidence.
In response to the recent EMA update, James Knowles, PhD, Head of Global Regulatory Policy at PPTA, said: “The EU decision is the latest in a line of similar regulatory shifts around the world that have led to regulatory changes, including the U.S., UK, Canada, and Australia. This will provide much-needed harmonized guidance to EU Member States, and likely increase in plasma donation in Europe.”
To read the EMA’s reflection paper, click here. For more regulatory updates from PPTA, visit pptaglobal.org.
June 25, 2024