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Parenteral Drug Association

PDA

The Parenteral Drug Association (PDA) is the leading global facilitator of science, technology and regulatory information.

Lobbying Activity

Response to European Partnership on Metrology

27 Aug 2019

27 August 2019 European Commission/Law Policies, information and services Measurement research – European Partnership on metrology (Horizon Europe Programme) via EC comment portal PDA appreciates the opportunity to provide input into shaping the Horizon Europe Program, specifically the creation of European metrology research networks by providing infrastructures for emerging traceable measurement technologies. We view this as a laudable effort to foster innovation and accelerated advancement in a critical area via a single coordinated, multinational approach. Metrology and good measurement practices are integral in establishing and maintaining pharmaceutical and biopharmaceutical product quality, not only regarding amount-of-substance (dose and potency) determinations, but also other product quality attributes. This science also plays a critical role in the calibration and maintenance of devices and technologies used across the pharmaceutical life cycle, from development through manufacturing. For this highly regulated industry, appropriate reflection of modern scientific and metrology approaches in international drug regulation and compendia is critical to advancing continual improvement in the industry and maintaining high quality standards for modern medicines. This requires active, coordinated, and streamlined dialog and adoption mechanisms to avoid international divergence in approaches. PDA believes that such international alignment is best undertaken proactively. Retrospective harmonization efforts have been shown to fall out of step with rapid technology advancement, which creates significant concern in the pharmaceutical space. With this in mind, we encourage the European Commission to think about how to effectively link and align the intended European Metrology Partnership with the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM), publisher of the European Pharmacopoeia. PDA also encourages the European Commission to assure continued connection between this activity and the activities of the International Bureau of Weights and Measures (BIPM), especially the Consultative Committee for Amount of Substance (CCQM), but also as appropriate with the World Health Organization (WHO) on the establishment of International Standards. Increased dialog in recent years has led to the inclusion of modern and updated metrology principles in the compendia and has improved the measurement approaches applied to critical pharmaceutical reference materials – a trend that should be fostered. Hopefully the establishment of a well-coordinated European metrology infrastructure will significantly contribute to that. PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality, and is an ANSI-accredited standards development organization. Our input has been prepared by a committee of experts in regulatory affairs and standards-setting on behalf of our Regulatory Affairs and Quality Advisory Board and Board of Directors. If you have any questions, please do not hesitate to contact PDA’s Vice President of Scientific and Regulatory Affairs, Dr. Tina Morris via email at tmorris@pda.org. Sincerely, Richard Johnson President and CEO cc: Tina Morris, PDA; Ruth Miller, PDA; Falk Klar, PDA
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