ISPE Advocates for Members with European Medicines Agency

ISPE is involved in two important EMA meetings that allow our member representatives to share concerns, ask questions, and provide case studies to regulators and inspectors. These types of open exchanges allow industry to have their questions answered on innovations, evolving draft guidelines, and other topics important to the industry. Regulators appreciate interacting with industry to have open exchanges and opportunities to learn, so these types of discussions provide broad benefits to membership and the industry.

Inspectors Working Group (IWG) Meetings

ISPE is one of 16 interested parties that has been meeting with the IWG of the EMA once a year. In this meeting, ISPE and the other interested parties present their input on items of interest to their members and the industry at large, and, as a group, they ask the IWG to provide feedback on questions and concerns. ISPE has been involved since the joint industry group was formed in 2013.

In 2024, the interested parties included the following: Active Pharmaceutical Ingredients Committee, Affordable Medicines Europe, AnimalhealthEurope, Association of the European Self-Care Industry (AESGP), European Association for Logistics and Transportation in Healthcare, European Compliance Academy/European QP Association (ECA/EQPA), European Federation of Pharmaceutical Industries and Association (EFPIA), European Industrial Pharmacists Group (GPIE/EIPG), European Healthcare Distribution Association (GIRP), International Pharmaceutical Excipients Council – Europe (IPEC), International Plasma and Fractionation Association (IPFA), ISPE, Medicines for Europe, Parenteral Drug Association, Plasma Protein Therapeutics Association, and Vaccines Europe. The organizations work together under the umbrella of EFPIA to discuss topics of interest to industry and the IWG.

ISPE is honored to have the opportunity to present the voice of its members, as these meetings are open only to EMA–invited organizations. Meeting preparation starts by delivering a list of suggested topics to the EMA. The interested parties gather in meetings to determine which topics are most urgent, merge their thoughts and questions into a cohesive and concise question or concern, and draft the 20-page letter requesting to meet with the IWG.

Once a meeting has been agreed to, the EMA may ask the group to prepare short presentations highlighting their points on selected topics. The EMA may also add their own topics to the meeting, perhaps other questions, or simply feedback on items from previous meetings. Each topic has an organization designated as the leader, with the support of other organizations. ISPE often is the leader for one to two topics per meeting, as well as supporting topics that other organizations are coordinating.

For example, in 2024, ISPE led the discussion on an International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9 EMA–IWG questionnaire. The EMA sent a questionnaire on quality risk management (QRM), and ISPE oversaw and coordinated answers from various organizations, resulting in a concise, consolidated answer delivered to the EMA at the March 2024 meeting. Specifically, the EMA provided five questions about the implementation of the new QRM Q9(R1) issued by ICH, for which the EMA was the regulatory rapporteur. Seven of the interested parties answered the questions, then ISPE provided a short presentation representing a single voice of the industry at the meeting.

Other topics at that meeting included implementation of Annex 1 (Manufacture of Sterile Medicinal Products), progress on Annex 4 (Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products), and Annex 5 (Manufacture of Immunological Veterinary Medicinal Products), reporting requirements related to drug shortage prevention, a potential ban of perfluoroalkyl and polyfluoroalkyl substances, and artificial intelligence (AI)/machine learning (ML) in manufacturing.

Listen-and-Learn Focus Groups

ISPE has been invited to attend the Listen-and-Learn Focus Group (LLFG) sessions organized by the Quality Innovation Group (QIG) of the EMA. These quarterly meetings are an opportunity for industry to present case studies on innovations that are being implemented to provide the EMA with an insider view of current operations and the challenges, particularly regulatory, in manufacturing facilities.

Members of the QIG include assessors, inspectors, and other professionals from the EMA and regulatory authorities, and sometimes invited observers such as the US FDA. The meetings allow manufacturers to share knowledge and experience and to work with the QIG to identify challenges and possible solutions. By allowing industry and regulators to discuss how they assess, identify, and manage risk, everyone is learning together, which is a beneficial exchange for everyone involved.

ISPE’s European Regulatory Advisor, Jean-Françoise Duliere, said of the meetings, “We consider, and the regulators consider, that we are all in the same boat and we are all learning because the technologies are quite innovative. For instance, AI, ML, platform technologies, process models, all are quite new and nobody’s very familiar with them… this is why we are trying to work together.”

ISPE has been involved since the initial LLFG meetings, which began only a couple of years ago. In many of the meetings, ISPE members, representing the companies where they work, have discussed case studies on the topics of the meeting. ISPE is often responsible for finding speakers on the topics of that meeting by asking relevant ISPE Communities of Practice to submit proposals on required topics.

By allowing industry and regulators to discuss how they assess, identify, and manage risk, everyone is learning together, which is a beneficial exchange for everyone involved.

The agenda for each LLFG is similar: there is an introduction to the QIG’s structure and operation at the beginning followed by two sessions covering two topics, each with four to five presentations by a variety of organizations, including a plenary discussion after each one. Then, LLFGs always end with a summary of challenges, solutions, and follow-up items.

The first LLFG meeting was held in March 2023 with two sessions, each beginning with a QIG-led presentation on current regulatory requirements and discussing two case studies. The first session was on continuous manufacturing facilities. The case studies focused on 1) the continuous manufacturing of biologicals and “time-to-results” analytics challenges, and 2) enabling implementation of continuous manufacturing through process models using a vaccine platform example, presented by Merck and GSK, respectively. The second session was on decentralized manufacturing facilities. The two case studies focused on 1) autologous advanced therapy medicinal products, and 2) decentralized manufacturing individual manufacturing units, presented by Tigen Pharma and MSD, respectively.

The second LLFG meeting was held in October 2023, and the topics were digital novel technologies applied to manufacturing and quality control testing. In particular, process models and digital twins were discussed, as well as AI and ML for GMP applications. Before the first session, there was a presentation by ISPE on enabling technologies in a regulated pharmaceutical industry.

The third LLFG meeting was held in June 2024, and the topic was process models. Before the first session, there was a presentation on QIG preliminary considerations on process models by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). A fourth meeting, held in November 2024, focused on platform technologies. The first of two meetings in 2025 was held 8–9 April and focused on personalized medicine.

The LLFGs are not open to the public, but recordings and minutes are available on the EMA website’s QIG page.

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