International Forum of Pharmaceutical Inspectorates: A Step Towards Global Harmonization of Standards

November 26, 2024, Dubai, United Arab Emirates

The International Forum of Pharmaceutical Inspectorates has concluded in Dubai. It brought together leading experts and pharmaceutical regulatory authorities from more than 30 countries to discuss key issues on marketing pharmaceuticals and GMP inspections.  The Forum was organized by the State Institute of Drugs and Good Practices with the support of the Ministry of Industry and Trade of the Russian Federation.

Dr. Fatima Al Kaabi, Director General, Emirates Drug Establishment, gave an opening address to the Forum participants. She highlighted the Forum will help establish long-term partnerships through experience and knowledge sharing which shape the future of pharmaceutical regulation. “This will ensure our work not only keeps in step with the times, but also lays the foundation for a safer and healthier world,” she said. “We recognize the importance of the Forum as a platform for meaningful collaboration, especially, today, with the rapid pace of technological advances and innovation in healthcare and pharmaceuticals call on the regulatory authorities around the world to embrace and implement innovations to ensure availability and affordability of safe and effective medicines.”

Dmitry Galkin, Head, Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of Russia, captured attention of the attendees at the national regulatory authorities’ responsibility to ensure the protection of interests and safety of people. “Some regulatory authorities follow the path of unilateral recognition and directly use the international standards, inspection and medicinal products evaluation results of the so-called countries with the stringent regulatory system. The use of global international standards does not guarantee that they are being interpreted and implemented the same way in different regions. At the same time, the “maturity” of the regulatory system does not always guarantee the ability to promptly respond to emerging difficulties in providing people with medicinal products, and be exemplary and universal for solving any objectives. The objective and responsibility of any national regulatory authority is to protect the interests of people. For our side, we are ready to communicate and exchange experiences on any collaboration platform,” said Dmitry Galkin.

Forum participants from all continents shared an overview on the best practices in joint inspections. In particular, Wayne Matheuw Muller, Medicines Control Officer, South African Health Products Regulatory Authority and GMP Technical Committee Chair, African Medicines Regulatory Harmonization, spoke about the prerequisites for the unification of regulatory authorities on the African continent. “The development of regulatory standards is growing at an exponential rate due to the impact of digital technology and artificial intelligence. Launching one center for the regulatory authorities of all African countries would allow us to unite, and therefore provide significant opportunities for access to the novel drugs,” he underlined.

During the event, the attendees spoke a lot about the regulatory reliance, the importance of information sharing, harmonization in the pharmaceutical industry as the foundation for safe and available medicinal products worldwide.

According to Darwin Yaser Marcelo Feliz, Chief of Staff, General Directorate of Drugs, Food and Sanitary Products, Ministry of Health and Social Welfare, the development of international cooperation and continuous experience exchange allows to improve the quality of life of people through providing access to quality medicines. Speaking about future, he emphasized that digital tools play an important role in the performance of pharmaceutical inspectorates, which make processes more transparent and provide access to global information databases. DIGEMAPS reaffirms its commitment to strengthening international collaboration and implementing innovative practices to position the Dominican Republic as a benchmark in pharmaceutical regulation.

Dr. Ranga Chandrashekar, Joint Drugs Controller, Central Drugs Standard Control Organisation (CDSCO), shared experience in the implementation of digital technologies in the National Regulatory Authority of India. A digital platform created by CDSCO in India enabled to file, process and issue licenses/permissions for various purposes of drug regulation. The platform combines several services in the first place – production and information database. The platform processed over 400,000 applications while more than 2,500 Indian drugs and cosmetics manufacturers are registered on the portal in order to submit the applications online. Talking about further objectives, Dr. Ranga Chandrashekar emphasized that data storage security and protection from hacker attacks including numerous applications of artificial intelligence technologies remain important priorities.

Aziz Dusmatov, Director, the State Unitary Enterprise “Center for Good Practices”, Agency for the Development of the Pharmaceutical Industry,  Ministry of Health of the Republic of Uzbekistan, spoke about collaboration  with the Russian Pharmaceutical Inspectorate. Today, the Russian Federation is one of the key suppliers of medicinal products to Uzbekistan.

The current format of the International Forum of Pharmaceutical Inspectorates has got the go-ahead from all the participants. The participants proposed to host the Forum annually which recognizes it as a significant event.

The idea of the Global Association of Pharmaceutical Inspectorates was announced during the discussions at the Forum. Such an organization could become an important platform for coordinating efforts and best practices exchange globally.

The event included expert sessions on topical issues related to the performance of pharmaceutical inspectorates as well as discussions on the best practices of GMP inspections.

The International Forum of Pharmaceutical Inspectorates has highlighted the importance of the global community to bolster efforts to advance the regulatory processes and ensure safety and efficacy of medicinal products for all patients.  The participants expressed confidence that the Forum would become a reliable platform for further development and strengthening of international cooperation in the area.