The 2nd International Forum of Pharmaceutical Inspectorates 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 Inspectorates (IFPI). This year's event brought together experts and representatives of regulatory authorities from more than 50 countries worldwide.
Across the two days, the shared key message of all discussions held at the Forum was clear: the global value of further deepening 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 Comes Together for Patient Safety.”
In his welcoming speech, the Co-Chair of the IFPI Expert Committee, 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 representative of the United Arab Emirates, Dr. Sheikha Al Mazroui, Director of the National Reference Laboratory, Drug Department, Emirates Drug Establishment, in her welcoming speech emphasized that countries striving to ensure a modern level of drug quality and accessibility for patients, as well as to develop their own R&D-based pharmaceutical industry, are convinced of the need to deepen the harmonization process. “Today we are discussing how regulatory harmonization can help ensure that medicines are available to patients in our countries through faster and safer pathways. 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 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 addressed separately.
Dmitry Galkin, Head of the Russian GMP Inspectorate and Director of the Department for Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, participated in the plenary session and stressed that the modern global regulatory system stands on the threshold of a new stage of transformation. “Today, data, technologies, and innovations spread faster than ever before. Under such conditions, regulatory frameworks cannot remain isolated: digital platforms, electronic dossiers, and 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, and antibody-based drugs. These open up completely new treatment possibilities, making some previously incurable diseases manageable or even curable, but on the other hand create challenges for healthcare systems worldwide, requiring continuous changes and new regulatory approaches. 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 key elements.” He also noted that the Russian Federation, possessing significant competencies and expertise in areas such as vaccines, radiopharmaceuticals, and biosimilars, is ready to share experience and remains open to cooperation.
Dr. Taruna Ikrar, Chairman of the Indonesian Food and Drug Authority (BPOM), spoke about harmonization processes within ASEAN. Alongside harmonization, ASEAN fosters recognition through the development of mutual recognition and trust agreements (MRA) between member countries, enabling regulators to rely on each other’s work. These mechanisms can be considered 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 a vital foundation for protecting public health. ASEAN is committed to actively contributing to 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. In global healthcare, cooperation is not only stronger than competition — it is the force that drives all of us forward.”
The speech by Dr. Olga Lidia Jacobo Casanueva, Director of the Center for State Control of Medicines, Medical Equipment and Devices of the Republic of Cuba (CECMED), addressed issues of ensuring access to medicinal products for resource-limited countries. Cuba’s experience shows that effective measures include WHO prequalification of medicines, cooperation within regional unions, participation in global and regional platforms for drug procurement, and sharing clinical trial data. To maintain sustainable drug supply, key mechanisms include strengthening domestic regulatory systems, investing in supply chains, developing flexible pricing regulation mechanisms, and aligning national regulatory frameworks with continuously evolving international standards.
Dr. Casanueva described the 2nd International Forum of Pharmaceutical Inspectorates in Abu Dhabi as a 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 GMP oversight, and address emerging challenges in the pharmaceutical supply chain. Cuba’s active participation strengthens international collaboration and underscores its commitment to ensuring the quality, safety, and effectiveness 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, and manufacturers’ experience in bringing drugs to market, including regulatory complexities that can be overcome through GMP harmonization initiatives.
Following the event, agreements were reached to continue joint work of GMP inspectorates within the IFPI Forum in 2026. Interaction within IFPI working groups, currently uniting regulatory authorities from 19 countries, will continue and expand. These groups cover areas such as approaches to inspection of sterile medicinal products, inspector qualification requirements, and quality systems of pharmaceutical inspectorates. Meetings were held online throughout the year. In addition, a decision was made to implement an initiative for joint GMP inspections of production sites in different countries to align inspection practices, non-conformity assessment, report preparation, and information exchange on inspection outcomes.
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 Inspectorates proved to be an effective platform for identifying pathways to a new level of regulatory reliance, once again demonstrating the importance of joint efforts by the global GMP community to improve regulatory approaches and standards in order to ensure the safety, effectiveness, and quality of medicinal products for patients.