International Society for Pharmaceutical Engineering
ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a nonprofit association serving its members by connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.
ID: 316626227774-56
Lobbying Activity
Response to Evaluation and revision of the general pharmaceutical legislation
3 Nov 2023
2 November 2023 European Commission, Directorate-General for Health and Food Safety Reference: CELEX number: 52023PC0193 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 COM/2023/193 final Dear Sir or Madam, The International Society for Pharmaceutical Engineering (ISPE) appreciates the opportunity to comment on the above-referenced Regulation. ISPE has the following high-level comments for consideration. Collaborative mechanism to advise on regulatory discretion proposals The Agency should consider a collaborative mechanism to advise on regulatory discretion proposals in advance of potential, substantial disruptive events. This collaborative mechanism could minimize product unavailability for patients. For example, products that require a Risk Management Plan and Shortage Mitigation Plan (regulatory plans) would present a meaningful impact to patients if unavailable. For these products the applicant holder could, as appropriate, proactively share their regulatory plans, which could include regulatory discretions, with the Agency for comments and suggestions. Application of Risk-Based Approaches for Drug Shortage Prevention and Mitigation Plan Ensuring availability of medically necessary drug products for patients in all end-markets is of paramount importance and ISPE believes that steps to address risks or offset supply disruptions with significant impact to patients should be rigorous. Applying similar levels of rigor and formality for less significant supply disruptions could dilute limited resources and reduce focus on ensuring a continuous supply of medically necessary products for the most vulnerable patient populations. Many of the following recommendations are intended to provide appropriate risk-based flexibility for the mitigation or prevention of drug shortages in alignment with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Harmonised Guideline -Quality Risk Management Q9(R1) to ensure a risk-balanced, resource-effective approach for both industry and the Agency. Harmonization Opportunities Terminology for aligned expectations (e.g., Critical Medicinal Products, Required Reporting Timeframes) should be standardized across the EU and ideally with other regulatory agencies System Interoperability & Transparency Proprietary Information shared by MAH with Agency should remain confidential and secure. ISPE is a not-for-profit organization of individual members from pharmaceutical companies, contract manufacturing organizations, suppliers and service providers, and health authorities. The 21,000+ members of ISPE lead scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle in more than 90 countries around the world. ISPE does not take a political position or engage in lobbying activities or legislative agendas. Specific comments on the articles are attached. We appreciate the opportunity to submit these comments for your consideration. Please do not hesitate to contact me if you have any questions. Respectfully, Thomas B. Hartman ISPE President and CEO thartman@ispe.org cc: Scott Billman, ISPE Chair
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
2 Nov 2023
2 November 2023 European Commission, Directorate-General for Health and Food Safety Reference: CELEX number: 52023PC0192 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC COM/2023/192 final Dear Sir or Madam, The International Society for Pharmaceutical Engineering (ISPE) appreciates the opportunity to comment on the above-referenced Directive. ISPE has significant comments related to distributed manufacturing in support of companies that may have or propose to have decentralised manufacturing facilities in several EU member states as well as other locations throughout the world. ISPE is a not-for-profit organization of individual members from pharmaceutical companies, contract manufacturing organizations, suppliers and service providers, and health authorities. The 21,000+ members of ISPE lead scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle in more than 90 countries around the world. ISPE does not take a political position or engage in lobbying activities or legislative agendas. Specific comments on the articles are attached. ISPE appreciates the opportunity to submit these comments for your consideration. Please do not hesitate to contact me if you have any questions. Respectfully, Thomas B. Hartman ISPE President and CEO thartman@ispe.org cc: Scott Billman, ISPE Board Chair
Read full responseResponse to Revision of the variation framework for medicines
19 Sept 2023
Please see attached feedback from the International Society for Pharmaceutical Engineering (ISPE). ISPE is a not-for-profit organization of individual members from pharmaceutical companies, contract manufacturing organizations, suppliers and service providers, and health authorities. The 21,000+ members of ISPE lead scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle in more than 90 countries around the world. ISPE does not take a political position or engage in lobbying activities or legislative agendas.
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