Regulatory Digest - 30 September 2020

Introducing ISPE’s Regulatory Digest

This new quarterly newsletter is dedicated to news about ISPE’s regulatory and quality activities. ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE provides a neutral environment where our individual Members and experts belonging to Health Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.


Drug Shortages

“Essential” Medicines

ISPE Offers Platforms to Progress Continuity of Supply of “Essential” Medicines

ISPE is prepared to provide platforms for discussion with appropriate government or regulatory agencies in support of global harmonization activities regarding defining “essential” medicines that would be beneficial to the industry and the patients it serves.

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Engaging with Health Authorities to Mitigate & Prevent Drug Shortages

Engage with Health Authorities to Mitigate & Prevent Drug Shortages

Transparent engagement with health authorities is a powerful opportunity for drug manufacturers to potentially mitigate or avoid drug shortages. This article by ISPE’s Drug Shortages team examines collaboration pathways and evolving notification requirements.

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A Challenging Year

2020 ISPE Annual Meeting & Expo: How Regulators are Responding to COVID-19’s Impact

ISPE’s Drug Shortages team will present an update on their current work as well as learnings from the COVID-19 pandemic supply chain pressures during the ISPE Annual Meeting and Expo on 5 November. The session will include an update from the USFDA drug shortages team.

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ISPE’s Drug Shortages Initiative

For nearly a decade, ISPE has been instrumental in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities related to the technical, manufacturing, quality and compliance issues related to drug shortages. More about ISPE’s Drug Shortages Initiative

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Supply Chains

Considerations for Pandemic-related Supply Chains

ISPE Considerations for Pharmaceutical Supply Chains related to the COVID-19 Pandemic

ISPE is uniquely positioned to support discussions with appropriate government or regulatory agencies on the content, relative risks, and implementation of legislation associated with pharmaceutical supply chains.

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ISPE Comments on Draft Guidelines

ISPE provides the opportunity for Members to propose comments on selected draft regulatory guidelines or guidances. The commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee.

EU GMP Annex 1 Sterile Products

As an official stakeholder of the EMA, ISPE was invited to comment on the second targeted consultation on Revision on Annex 1, Manufacture of Sterile Products of the EU GMP guidelines.

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A live webinar presenting ISPE’s major points was delivered by members of ISPE’s Annex 1 Comment Lead Team on 10 September. A recorded version is available.

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A panel of regulators - including the Annex 1 rapporteur - will discuss Annex 1 and the industry response during the ISPE Virtual Annual Meeting & Expo on 5 November 5. The session will feature a live Q&A with regulators.

PIC/S GMP Guide Annexes for ATMPs and Biologics

ISPE was one of six organizations selected by PIC/S to provide feedback on nine questions related to the manufacture of these complex products, and on how the harmonised international GMP standards drafted ensure quality products are administered to patients.

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For Annex 2A, ATMPs, ISPE recommended that a table of examples of how the guide could apply to manufacturing steps of ATMPs be extended to include virus, plasmid and messenger RNA (mRNA) products since these are not covered by ICH Q7, EU GMP Part II and PIC/S GMP Guide Part II. ISPE SMEs presented justified recommendations directly to the PIC/S rapporteur.

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EU Pharmaceutical Strategy - Timely Patient Access to Affordable Medicines

ISPE responded to the EU Pharmaceutical Strategy Roadmap that it would welcome being engaged as part of the “Additional consultations” process as a stakeholder with significant technical expertise and a broad portfolio of relevant projects.

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ISPE reiterated the projects relevant to the EMA Network Strategy to 2025 in a response questionnaire to the Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA).

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WHO and OECD draft documents

Teams of ISPE members provided substantial comments and recommendations to the WHO regarding their working documents for Data Integrity, Water for Pharmaceutical Use, and Good Reliance Practices in Regulatory

Decision-making, and to the Organization for Economic Co-operation and Development (OECD) on GLP Data Integrity.

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Innovation & Harmonization

ISPE’s Input to NASEM Consensus Report

ISPE Input to NASEM study on Identifying Innovative Technologies to Advance Pharmaceutical Manufacturing

At the request of the National Academy of Science, Engineering, and Medicine (NASEM) and following workshops at which ISPE Members presented, ISPE provided input to a study on Identifying Innovative Technologies to Advance Pharmaceutical Manufacturing. ISPE would welcome a discussion to advance international regulatory harmonization for the deployment of new and innovative manufacturing technologies.

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For more information, contact Carol Winfield, ISPE Sr. Director Regulatory Operations