Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference

Ian Jackson

Expert GMP Inspector

MHRA

Jackson began his keynote presentation by laying out the role and purpose of PIC/S. As an organization composed of health authority members, PIC/S does not perform its own inspections or authorizations; that responsibility remains with the individual agencies. Instead, he clarified, PIC/S provides support and training to the regulators who inspect manufacturing facilities, and it works to ensure that inspection procedures and guidelines are robust and equivalent from country to country. It primarily focuses on GMP, although its efforts also tie in with pharmacovigilance, good clinical practice (GCP) standards, and good distribution practice (GDP).

Most of the work is done on a volunteer basis by people with jobs at the member agencies, Jackson noted.

To show the importance of PIC/S, Jackson gave a brief history of the organization and the regulations that led up to it. Pivotal moments in pharmaceutical regulation and GMP development were catalyzed by disasters that harmed patients, such as the Sulfanilamide Elixer disaster of 1937 and the Thalidomide disaster of 1961. A slide showed how the responses to these disasters snowballed into a global effort to safeguard the production of medicines. PIC/S is now a key part of that effort, with patient welfare as its ultimate focus.

Jackson acknowledged that the innovations in the field come from industry. Once companies have developed a new product or technology and taken it through the approval process with a mature regulatory authority, that authority may bring it to PIC/S for development of harmonized training and guidance that can be applied worldwide.

To ensure regulators from different regions all understand and apply concepts in the same way, PIC/S spends a lot of time working on terminology and definitions, Jackson added.

As an example of an ambitious PIC/S project, Jackson discussed Annex 1, a GMP guide on the manufacture of sterile products. About 10 years ago, PIC/S began working with the European Medicines Agency (EMA) and the World Health Organization (WHO) to update Annex 1. The revised guide was released in 2022, a landmark achievement that marked the most countries ever adopted the same set of pharmaceutical regulatory standards. PIC/S is now working on training programs to help regulators apply Annex 1. The fact that it's taken a decade to reach this training phase illustrates how challenging it is to ensure GMP practices and oversight work the same way everywhere, according to Jackson.

Next, Jackson gave a more detailed look at the inner workings of PIC/S, with an emphasis on how it ensures all its members are upholding the organization’s standards. Each member health authority is expected to oversee inspections and licensing in line with PIC/S requirements, and this should be embedded in national legislation. PIC/S conducts routine audits to ensure each member’s activities are equivalent and are implemented consistently.

PIC/S also helps to bring immature health authorities up to these standards if they wish to join the organization. Jackson described how PIC/S guides and supports potential members, building up their capacity and confidence until they can pass the assessments and be welcomed onto the team.

Training regulators is a crucial part of the PIC/S mission, and Jackson enumerated the forms this training takes. For example, members can take advantage of seminars, expert circles, and training courses for inspectors and auditors. They can also participate in joint inspections with other health authorities, sharing knowledge and experience through cooperative work at the same facility.

The educational side of PIC/S is now organized under the PIC/S Inspectorates' Academy (PIA), a recent initiative with many programs still under development. Although some of the training resources are hidden from the general public, Jackson encouraged members of the audience to explore the website, as it contains a wealth of information relevant to industry.

Jackson emphasized that PIC/S networks and cooperates with many other organizations, thereby extending its global reach. He showed a slide that listed some of these partners, including the WHO, the International Coalition of Medicines Regulatory Authorities (ICMRA), the United Nations Children's Fund (UNICEF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and ISPE.

Next, Jackson covered the official PIC/S strategic plan, mission, and vision. According to the vision, each site would ideally engage with a single inspection team, and that team would provide everything needed by regulators in other countries, resulting in global approvals for products. This could happen through a combination of reliance and direct collaboration.

He then explained how PIC/S is addressing the technological advances of industry, particularly artificial intelligence (AI) and GAMP^®. These are key innovation areas where drug manufacturing is changing, and of course they are a major focus of ISPE as well. Through PIC/S, regulators are working to understand and keep up with these advances so that they can facilitate their use and regulate them appropriately. Indeed, Jackson added, PIC/S’s primary global training event is its annual seminar, and the theme for this year’s seminar is advanced technologies.

Jackson stressed the importance of information sharing. PIC/S has confidentiality agreements in place to enable regulators from different agencies to share their findings and rely on each other’s assessments. He urged industry members to take advantage of the PIC/S infrastructure by also sharing information themselves. When a facility is inspected by an authority that is a member of PIC/S, the company can proactively share the results of that inspection with other PIC/S authorities, he said. This can be valuable when forging new relationships with regulators who haven’t been involved before.

Jackson wrapped up his presentation by discussing the common goals and interests of PIC/S and the ISPE members in his audience. He said both sides must work together so that regulation can benefit patients.

“We want to work with the likes of ISPE,” he said. “We want to learn from you.”

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