NEWS IFPI EN

IFPI Publishes the 2026 Forum Programme: International Dialogue on the Future of Pharmaceutical Regulation

The International Forum of Pharmaceutical Inspectorates (IFPI) presents the programme for 2026. The event will bring together representatives of national regulatory authorities, international organisations, pharmaceutical companies and the expert community to discuss current issues in regulation, the quality assurance of medicinal products and the development of international cooperation.

IFPI 2026 will take place on 16–17 November in Hanoi, Viet Nam. Key topics will include the harmonisation of regulatory approaches, the implementation of Good Regulatory Practices (GRP), improvements in GMP inspection practices and approaches to regulating advanced therapy medicinal products (ATMPs).

International Participation

The first announced speakers include representatives of regulatory authorities and organisations from different regions of the world, including:

  • The World Health Organization (WHO);
  • The Association of Southeast Asian Nations (ASEAN): Viet Nam — Drug Administration of Vietnam (DAV); Indonesia — Indonesian Food and Drug Authority; Malaysia — National Pharmaceutical Regulatory Agency (NPRA);
  • The Eurasian Economic Union (EAEU) — Eurasian Economic Commission (EEC);
  • The African continent — African Medicines Agency (AMA), African Medicines Regulatory Harmonisation (AMRH) initiative and South African Health Products Regulatory Authority (SAHPRA);
  • North Macedonia — Macedonian Agency for Medicines and Medical Devices;
  • Russia — Ministry of Industry and Trade of the Russian Federation and the Federal State Budgetary Institution “State Institute of Drugs and Good Practices” (SID & GP);

The programme will also feature representatives of international pharmaceutical and technology companies, including AstraZeneca, Roche and Fedegari, as well as experts from consulting and specialised organisations such as Parexel, PVP Labs and others.

Key Topics on the Programme

Good Regulatory Practices (GRP)

Participants will discuss experience in implementing GRP in different countries, WHO approaches to regulatory harmonisation and EAEU practices. The focus will be on the transparency and predictability of regulatory procedures, process optimisation and the adaptation of international experience to national contexts. These issues are important for improving the effectiveness of regulatory systems and fostering constructive interaction between regulators and manufacturers.

Advanced Therapy Medicinal Products (ATMPs) and Radiopharmaceuticals

The development of CAR-T therapies and other advanced therapy medicinal products (ATMPs) requires specialised approaches to manufacturing, quality control and regulation throughout a product’s lifecycle. Dedicated presentations will address blood and plasma products, GMP requirements and practical challenges faced by manufacturers and inspectorates.

The radiopharmaceuticals session will cover regulatory aspects, specific features of GMP inspections, requirements for facilities, equipment and personnel, and common deficiencies in the manufacture of radiopharmaceutical medicinal products. This field requires particular attention to quality and safety due to the specific nature of working with radioactive materials.

GMP Inspections and Improving Regulatory Procedures

The programme will also address key principles of a GMP inspectorate’s quality management system, risk-based approaches to planning GMP inspections and the assessment of contamination control strategies. Regulatory representatives and internationally recognised experts will examine practical inspection challenges, regulatory expectations and opportunities to improve the efficiency of cooperation while maintaining medicinal product quality and safety requirements.

A Platform for International Cooperation

In addition to the business programme, IFPI 2026 will include an interactive exhibition area and B2B, B2G and G2G meetings. These activities will create further opportunities for professional networking and for discussing prospects for cooperation between regulatory authorities and business representatives.

IFPI 2026 will continue to advance international dialogue on pharmaceutical regulation, inspections and quality assurance, bringing together strategic harmonisation objectives and practical challenges arising from developments in pharmaceutical technologies.

The programme is available for review. Topics, timings and session line-ups may be subject to change.

16–17 November 2026 | Hanoi, Viet Nam