2025 ISPE Singapore Conference and Exhibition Recap: Summary of Regulatory Sessions

Keynote Presentations by Regulators

Emer Cooke, Executive Director of the European Medicines Agency (EMA), gave a keynote presentation, “Fostering Manufacturing Innovation in the European Union (EU) for the Benefit of Patients.” She indicated that fostering the support of manufacturing innovation was vital for patients worldwide and that many initiatives were underway both in Europe and worldwide, such as:

• Building trust in new technologies such as artificial intelligence (AI)
• Decentralized manufacturing
• Revised EU legislation

She indicated that international knowledge-sharing and regulatory convergence was key to supporting manufacturing innovation.

Xiaoming Gao, Toxicologist-in-charge, Center of Laboratory Proficiency Evaluation, National Institutes for Food and Drug Control (NIFDC) of the National Medical Products Administration (NMPA) gave a keynote presentation of the operations of NIFDC. His presentation outlined NIFDC’s preparation plans for assessment by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as part of NMPA’s application for PIC/S membership.

Regulatory Panel Discussion: Regulating for Innovation, Agility, Streamlining, and Simplification

A regulatory panel discussion involved regulators from EMA ( Emer Cooke ), the Ministry of Food and Drug Safety (MFDS), South Korea (Jeong Kim ), PhD, the Food and Drug Administration,the Philippines ( Joyce Cirunay) and Health Sciences Authority, Singapore ( Sia Chong Hock ). The discussion was moderated by the Regulatory Consultant to ISPE Singapore (Bob Tribe) and covered the following topics:

• Inspection reliance: The PIC/S strategy and EMA pilot demonstrate that mutual recognition of inspection outcomes is not aspirational—it is already delivering efficiency while maintaining oversight.
• Digitalization: The forthcoming revision of Annex 11 (Computerized Systems) and the draft Annex 22 on AI reflect the need for regulatory science to keep pace with advanced analytics, automation, and data integrity requirements.
• Decentralized manufacturing: Provisions in the EU’s new pharmaceutical legislation and guidance initiatives with MHRA and the International Coalition of Medicines Regulatory Authority (ICMRA) are building frameworks for point-of-care and distributed models of production.
• Global collaboration: Expansion of the Association of Southeast Asian Nations Mutual Recognition Arrangement (ASEAN MRA) to active pharmaceutical ingredients (APIs) and biologicals, supported by inspector training, demonstrates how capacity-building can strengthen regulatory convergence and patient access.
• Preparedness: From unannounced inspections to pandemic readiness, regulators stressed resilience as a scientific and public health necessity.
• GMP is evolving from a compliance mechanism to a global framework for innovation, trust, and patient safety.

Regulatory Presentations

Kim, PhD, with MFDS for South Korea described the pharmaceutical industry landscape in South Korea which includes 512 pharmaceutical manufacturers and 451 pharmaceutical importers. Kim gave an overview of MFDS’s global GMP cooperation, including PIC/S membership in 2014 and recent mutual recognition agreements with Switzerland and Singapore.

Wang Chong, National Institutes for Food and Drug Control (NIFDC) of the NMPA gave a presentation outlining medicinal products sampling and inspection in China. He also described the sampling system, the laws applied and the cooperation between central and provincial agencies throughout China, and the continuous improvement in order to provide high quality of medicines and avoid counterfeit products in the market.

Sumei Li, Center for Food and Drug Inspection (CFDI) of the NMPA gave a presentation on key inspection considerations for the contamination control strategy (CCS) for aseptic facilities. She also described the new Annex 1 implementation timeline, which needed to be met by March 2025, and provided the main issues related to the CCS and the regulatory GMP inspections that are aligned to those requirements.

Tribe gave a presentation on the Pan Pharmaceuticals crisis that happened in Australia in 2003. This crisis involved the largest ever medicines recall undertaken at that time. He described some of the lessons learned from the crisis including the need for both companies and regulatory authorities to have crisis management procedures in place.

Regulatory Panel Discussion: Questions Answered

A regulatory panel discussion shared insights and invited attendees to ask questions, with regulators from EMA ( Emer Cooke), the Ministry of Food and Drug Safety, South Korea (Jeong Kim, PhD ), the Food and Drug Administration for the Philippines (Joyce Cirunay) and Health Sciences Authority for Singapore (Sia Chong Hock). The panel was jointly moderated by Vee Revithi, PhD (former Regulator, Greek Medicines Agency) and Tribe and discussed the following topics:

• World Health Organization (WHO) Global Benchmarking: The benefits of a regulatory authority achieving Maturity Level 4 under the WHO Global Benchmarking Scheme was discussed, noting that both HSA for Singapore and MFDS for South Korea were two of only three regulatory authorities that had achieved this level.
• MRA between EU and US Food and Drug Administration (US FDA): Questions addressed included: How will the MRA work in case US FDA implements an unannounced inspections practice in EU? As this MRA is already in place since 2019, it is expected to provide all the necessary ways of cooperation between US FDA and all the EU member states’ authorities, including possible unannounced inspections. Quite often the logistics can be challenging in the case of those inspections.
• Pan Pharmaceuticals Crisis: This discussion inquired: If AI was available in 2003, would it have been useful in the investigation of the Pan Pharmaceuticals incident? Tribe noted that it would have been useful in cataloguing the problems found during the investigation and detecting trends. Therefore, a person with IT experience would have been useful to have on the investigation team .

The 2025 ISPE Singapore Conference and Exhibition was well-attended and provided helpful insights as well as meaningful discussions for its participants. The next conference is taking place on 19-21 August 2026 at Suntec Singapore.

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