Statement
23 May 2026
79th session of the World Health Assembly (WHA79): Harmonization of regulatory approaches, governance, and standards for data, digital health, and artificial intelligence in the health sector
On 23 May 2026, IFPMA delivered a statement on the harmonization of regulatory approaches, governance, and standards for data, digital health, and artificial intelligence in the health sector at the 79th session of the World Health Assembly in Geneva. Noting the previous work on digital health transformation, AI, and data governance, and the first WHO...
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Position paper
4 Mar 2026
Artificial intelligence in pharmaceutical manufacturing – navigating innovation and regulation
Artificial Intelligence (AI) and Machine Learning (ML) are rapidly transforming various sectors, and the pharmaceutical manufacturing industry is no exception. This paper explores how the pharmaceutical industry may use individual applications of AI in pharmaceutical manufacturing and control. It describes the evolving regulatory landscape and provides key considerations for national regulatory authorities (NRA) when reviewing...
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Position paper
11 Dec 2025
The role of assessment reports in enabling regulatory reliance – perspectives from the pharmaceutical industry
Reliance in decision-making offers a pathway for national regulatory authorities (NRAs) to consider evaluations conducted by other NRAs while maintaining accountability for their decisions. By avoiding duplicative reviews and optimizing resource allocation, the use of regulatory reliance can lead to faster patient access to safe, effective, and high-quality medical products in a timely manner. A...
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