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MediPhorum response to Annex XV restriction report proposal for a restriction on per- and polyfluoroalkyl substances

14 April 2024
MediPhorum Drug Delivery
MediPhorum response to Annex XV restriction report proposal for a restriction on per- and polyfluoroalkyl substances
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MediPhorum acknowledges the concerns raised regarding the potential adverse effects of per- and poly-fluoroalkyl substances (PFAS) on human health and the environment. It fully supports efforts to minimize and mitigate the presence of these and other potential substances of concern in manufacturing processes and products. The biopharma and medical technology industry shares a responsibility to ensure the safety and well-being of patients.

However, it is crucial to approach the proposal by carefully considering the impact on the manufacturing and supply of critical, lifesaving products—the development and production of which involve complex processes requiring adherence to stringent quality standards, regulatory compliance, and extensive testing. Any significant changes in practices can have far-reaching consequences for patients, innovation, and the ability of the industry’s supply chains to respond.

MediPhorum asks the ECHA to provide the highly regulated biopharma and medical technology industry with appropriate exemptions or derogations to find, test, and validate alternatives and execute a transition out of these materials (where alternatives are available). If not, there will be a real threat to the global availability of critical vaccines, biotherapeutics, medical devices and in vitro diagnostics (IVDs). In many cases, no suitable alternatives to currently used PFAS are available, and there is insufficient global capacity for validating alternatives or managing subsequent regulatory change submissions within the proposed ECHA implementation timeframe and listed derogation periods.

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