The 2nd International Forum of Pharmaceutical Inspectors in Abu Dhabi Charts New Pathways for Global GMP Harmonization

On November 24–25, 2025, Abu Dhabi (UAE) hosted the 2nd International Forum of Pharmaceutical Inspectors (IFPI). This year’s event brought together experts and representatives of regulatory authorities from more than 55 countries worldwide. For the second year in a row, the Russian Federation is the Co-Chair of the Forum’s Organizing Committee, underscoring its leading role in global regulatory harmonization processes.

Across the two days, the shared key message of all discussions held at the Forum was clear: global value of further deepening of the GMP regulatory harmonization and information exchange, fostering transparency, convergence of regulatory approaches, and expansion of cooperation in the field of pharmaceutical inspections is growing. This year, the forum served as a platform operating under the motto “Where the World Unites for the Patient Safety.”

In his welcoming speech, the Co-Chair of the IFPI Expert Committee, Deputy Head of the Russian GMP Inspectorate, Director of the “State Institute of Drugs and Good Practices,” Vladislav Shestakov, noted: “Global challenges lead to the necessity of seeking global responses. And only such a response will lead us to tangible results. Today we realize that without constant and close interaction, information exchange on a daily routine basis, without the ability to share expertise and experience, as well as inspection results — we will not be able to achieve the required level of regulatory reliance and mutual recognition that we have been discussing on various platforms for decades. This is precisely why the Forum is important, as it unites us to build bridges between regulatory systems, discuss unified approaches to inspection, and jointly seek solutions that will make the global medicinal product circulation more transparent and reliable.”

The IFPI program opened with a high-level plenary session featuring representatives of regulatory authorities from Russia, Indonesia, Jordan, Belarus, Cuba, as well as the African Medicines Regulatory Harmonization (AMRH) initiative. Experts discussed cooperation, the current status, and emerging trends in GMP regulatory convergence within regional unions and associations. Primarily, the integration experience of the EAEU, ASEAN, and the association of African countries. Issues of ensuring access to modern, effective, safe, and high-quality medicinal products in the healthcare systems of different states, and the opportunities that regulatory harmonization opens for expanding such access, were separately addressed.

Dmitry Galkin, Head of the Russian GMP Inspectorate, Director of the Department for Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, participated at the plenary session and stressed that the modern global regulatory system stands on the threshold of a new stage of its transformation. “Today, data, technologies, and innovations spread faster than ever before. Under such conditions, regulatory frameworks cannot remain isolated: digital platforms, electronic dossiers, cross-border data exchange require common, coordinated approaches at the global level. At the same time, every year the global market is replenished with new advanced technology medicinal products, including gene therapy drugs, cellular immunotherapy, antibody-based drugs, which open up completely new treatment possibilities, making some previously incurable diseases manageable or even curable, but on the other hand — create a challenge for all healthcare systems in the world for continuous changes and the search for new approaches in regulating the circulation of these drugs. As a result, a new architecture of global pharmaceutical regulation is forming, where mutual recognition of inspections, data exchange, and comparability of quality standards become the key elements.” He also noted that the Russian Federation, possessing significant competencies and expertise in certain areas, such as vaccines, radiopharmaceuticals, biosimilars, is ready to share experience and open to cooperation.”

Dr. Taruna Ikrar, Chairman of the Indonesian Food and Drug Authority (BPOM), spoke about harmonization processes within ASEAN. Alongside the harmonization trend, ASEAN fosters recognition through developing mutual recognition and trust agreements (MRA) between member countries. As a result, the regulator of one country utilizes the work of another. These mechanisms, as noted in the speech, can be considered as possible models for broader interaction at the global level. “The IFPI Forum demonstrates how global cooperation can significantly strengthen regulatory systems and enhance the quality, consistency, and integrity of GMP inspections worldwide. This platform allows us to openly exchange experience, learn from each other, and strengthen mutual trust between inspection bodies, which is an important foundation for protecting public health in all countries. ASEAN is committed to actively contributing to the realization of this shared vision. Through harmonizing standards, capacity building, and a science-based approach to inspections, we strive to become a reliable regulatory partner in the global pharmaceutical ecosystem. Indonesia is proud to support these efforts, ensuring that our collective work ultimately leads to improved access to safe, effective, and high-quality medicines for patients worldwide. In global healthcare, cooperation is not only stronger than competition — it is the force that drives all of us forward.”

The representative of the United Arab Emirates, Dr. Sheikha Al Mazroui, Director of the National Reference Laboratory, Drug Department, Emirates Drug Establishment, emphasized that countries striving to ensure a modern level of drug quality and their accessibility for patients, as well as to develop their own R&D-based pharmaceutical industry, are convinced of the efforts to deepen the harmonization process. “Today we are discussing how regulatory harmonization can help ensure that medicines are available to patients in our countries on faster and safer pathways. And, undoubtedly, the system of GxP practices is the most important part, the core of the entire process. Closer integration into global regulatory processes and the development of digital healthcare are the tools that ensure the success of this movement. In this regard, the Forum provides an important chance for the entire GMP community to gather and discuss the challenges we face and how we can help each other overcome them.”

The speech by Dr. Olga Lidia Jacomino Casanueva, Director of the Center for State Control of Medicines, Medical Equipment and Devices of the Republic of Cuba (CECMED), touched upon issues of ensuring access to medicinal products for resource-limited countries. Cuba’s experience shows that effective measures include mechanisms such as: WHO prequalification of medicines, cooperation within regional unions, participation in global and regional platforms for drug procurement, and sharing clinical trial results data. To maintain the sustainability of drug supply, the following mechanisms are important: 1) strengthening the domestic regulatory system, 2) investment in supply chains, 3) development of flexible pricing regulation mechanisms, and 4) alignment of national regulatory frameworks with continuously evolving international standards and rules.

Dr. Casanueva described the 2^nd International Forum of Pharmaceutical Inspectors in Abu Dhabi as pivotal event for advancing global regulatory convergence. She emphasized that the forum provided an exceptional platform for inspectors and regulators to harmonize strategies, share best practices in Good Manufacturing Practice (GMP) oversight, and address emerging challenges in the pharmaceutical supply chain. Ms. Jacobo highlighted that Cuba’s active participation strengthens international collaboration and underscores the commitment to ensuring the quality, safety, and efficacy of medicines through robust and aligned inspection standards.

During the second day of the forum, experts discussed practical steps for harmonizing regulatory requirements for drug manufacturing, approaches to mutual recognition of GMP inspection reports, inspection of biological medicinal products, as well as manufacturers’ experience in bringing drugs to the markets and the associated regulatory complexities that can be overcome through GMP regulatory harmonization initiatives.

Following the event, agreements were reached to continue the joint work of GMP inspectorates within the IFPI Forum in 2026. Primarily, interaction within the IFPI working groups, which currently unite regulatory authorities from 19 countries, will continue and expand. The groups cover areas such as: 1) Approaches to inspection of sterile medicinal products, 2) Inspector qualification requirements, 3) Quality system of pharmaceutical inspectorates. Meetings were held online throughout the year. In addition to these well-established formats, a decision was made to implement an initiative for joint GMP inspections of production sites in different countries to align approaches in inspection practices, non-conformity assessment, reports’ preparation, and further information exchange of the outcomes of the inspections.

Representatives of the Eurasian Academy of Good Practices (EAGP) conducted a master class on VR technologies in GMP specialists’ training for all forum participants. The Academy’s “VR Plant” educational initiative is already widely used for training personnel at pharmaceutical enterprises and students of pharmaceutical universities in Russia.

The 2nd International Forum of Pharmaceutical Inspectors proved to be the effective platform to  find pathways to new level of regulatory reliance, once again demonstrating the importance of the joint efforts of the global GMP-community aimed at improving regulatory approaches and standards to ensure the safety, efficacy, and quality of medicinal products for patients worldwide.