Technologies and strategies reshaping regulatory trends
Major regulatory changes in 2025
Future outlook
Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based platforms, and other innovations in drug discovery and development. Looking ahead, this article highlights the key trends expected to shape the regulatory landscape of pharmaceutical manufacturing in 2025.
Regulatory agencies—including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Brazil’s National Health Surveillance Agency (ANVISA)—are responsible for overseeing compliance to ensure that pharmaceutical companies maintain high standards in drug development.1
To meet these expectations, the pharmaceutical industry must adhere to rigorous regulations that safeguard drug effectiveness, safety, and quality throughout the development and manufacturing process.
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Technologies and strategies reshaping regulatory trends
The adoption of artificial intelligence (AI) and large language models (LLMs) is rapidly reshaping clinical research and drug development.2
These advanced tools allow researchers to screen millions of compounds from chemical databases to identify promising therapeutic candidates, significantly reducing the time and cost typically required to explore the vast chemical space.
In clinical trials, AI models enhance the selection of patient populations and help predict outcomes, leading to higher success rates for novel drug development.3
However, as AI becomes more embedded in the drug discovery pipeline, regulatory bodies have stepped up efforts to ensure these technologies are integrated safely and ethically. To that end, regulators are increasingly engaging with industry stakeholders to adapt and evolve policy frameworks.
Beyond AI, cloud-based technologies are pivotal in modernizing regulatory submissions and data exchange.4 Cloud platforms enable real-time collaboration and offer greater flexibility in product development and lifecycle management.
For example, the FDA’s PRISM Project demonstrated how a secure, cloud-based system can streamline regulatory submissions and scientific reviews. Such frameworks have the potential to accelerate approval timelines, ease submission bottlenecks, and encourage international collaboration among regulatory agencies.
Despite these advantages, cloud-based systems also raise concerns about data security and intellectual property protection. These risks have prompted regulators to develop more stringent guidelines aimed at safeguarding sensitive information.
To support evidence-based decisions, regulatory agencies are also leveraging real-world evidence (RWE). Multiple studies suggest that incorporating RWE into regulatory evaluations has improved the overall quality of decisions on new drug approvals.5
Standardization is another key focus area. Broader adoption of the electronic common technical document (eCTD) format within the International Council for Harmonisation (ICH) framework is helping bring greater consistency to regulatory submissions.6
Standardized documentation not only reduces duplication and minimizes errors but also provides pharmaceutical companies with a more predictable and streamlined submission process.
Market Report 2025: Pharmaceutical Manufacturing
Major regulatory changes in 2025
In January 2025, the US FDA published a draft regulatory guidance entitled “The Considerations for Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”.7
The regulatory guidance aimed at formulating a risk-based credibility assessment framework to examine the usefulness of AI models in decision-making about the safety and efficacy of drugs and biological products. The 2025 guidelines also emphasize transparency, data quality, and continuous monitoring.
From February 2, 2025, pharmaceutical companies in the European Union (EU) region must comply with AI literacy requirements and avoid AI practices that are prohibited under Article 514. By August 2, 2025, obligations for general-purpose AI models will take effect, which might impact AI-driven drug development and regulatory submissions.8
Corporate Sustainability Reporting Directive (CSRD), an EU directive mandate effective from 2025, requires pharmaceutical companies to disclose environmental, social, and governance (ESG) activities to strengthen transparency in sustainability efforts.
The Corporate Sustainability Due Diligence Directive (CSDDD) has been applied in both EU and non-EU pharma companies to promote ethical business practices. This policy was established to foster sustainable and responsible behavior within their supply chains by identifying, preventing, and alleviating adverse impacts on the environment and the general population.
The Digital Operational Resilience Act (DORA) is an EU regulation, effective from January 17, 2025, that focuses on ensuring a secure financial system in Europe.
DORA ensures strong cybersecurity resilience measures for financial entities for higher transparency in financial transactions and supply chain financing in pharmaceutical companies.
In January 2025, another EU regulation-Health Technology Assessment Regulation (HTAR), took effect. This EMA regulation promotes collaboration between regulatory and health technology assessment bodies, thereby accelerating patient access to innovative treatments by harmonizing the evaluation process. This regulation also ensures the high quality of new technology, medical devices, and medicines through coordinated assessments.
The FDA encourages pharmaceutical companies to adopt advanced manufacturing technologies (AMTs) to improve the reliability and robustness of the manufacturing process.
AMTs would be significantly beneficial because they could reduce drug development time and enhance product quality. FDA’s AMT guidance could also effectively help maintain the supply of drugs that are life-supporting
The FDA’s Breakthrough Therapy program and the EMA’s PRIME scheme focus on streamlining approval pathways for ground-breaking therapies. These guidelines could reduce the time required to develop new therapy and enable a quick treatment for unmet medical needs.
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Future outlook
2025 presents the pharma industry with regulatory modernization driven by cloud-based technologies, AI-powered tools, and expanded global harmonization efforts. Regulatory agencies will continue fostering innovation while ensuring patient safety, ethical conduct, and data integrity.
Many opportunities are awaiting amidst the uncertainties that emerged due to the implementation of new technologies in drug development.
Regulatory frameworks are evolving to adopt new ways of scientific thinking and ensure high-quality treatment.
Pharmaceutical leaders must anticipate the changes in the regulatory landscape to stay ahead and quickly integrate compliance strategies into their long-term research and development (R&D) and commercialization plans.
Pharma companies that enable quick adaptation to regulatory shifts will have a competitive advantage in launching new therapies to the market faster and more efficiently.
References
- Joppi R, et al. Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval. Br J Clin Pharmacol. 2020;86(1):170-174. doi: 10.1111/bcp.14130.
- Niazi SK, Mariam Z. Artificial intelligence in drug development: reshaping the therapeutic landscape. Ther Adv Drug Saf. 2025. doi: 10.1177/20420986251321704.
- Chopra H, et al. Revolutionizing clinical trials: the role of AI in accelerating medical breakthroughs. Int J Surg. 2023;109(12):4211-4220. doi: 10.1097/JS9.0000000000000705.
- Khalil R, Macdonald JC, Gustafson A, Aljuburi L, Bisordi F, Beakes-Read G. Walking the talk in digital transformation of regulatory review. Front Med (Lausanne). 2023 Jul 26;10:1233142. doi: 10.3389/fmed.2023.1233142.
- Burns L, et al. Real-world evidence for regulatory decision-making: updated guidance from around the world. Front Med (Lausanne). 2023;10:1236462. doi: 10.3389/fmed.2023.1236462.
- Macdonald JC, et al. Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution? Front Med (Lausanne). 2021 May 21;8:660808. doi: 10.3389/fmed.2021.660808.
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products. Food and Drug Adminidtration.2025. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological
- Commission publishes the Guidelines on prohibited artificial intelligence (AI) practices, as defined by the AI Act. European Comissions. 2025. Available at: https://digital-strategy.ec.europa.eu/en/library/commission-publishes-guidelines-prohibited-artificial-intelligence-ai-practices-defined-ai-act
Further Reading