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”.
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 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.
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.
Reference:
Regulatory Trends in Pharma Manufacturing: Key Changes to Watch in 2025
Today we announce that Exim is rebranding as ExSyn. We are presenting a new brand identity and website as a reflection of our relentless transformation over the course of 30 years serving the pharma and chemical industries. The new brand builds upon our core strengths as a sourcing company and captures our most essential duty: helping improve people’s health and lives.
Glycolaldehyde dimer is the cyclic dimeric form of glycolaldehyde, the simplest hydroxyaldehyde. Glycolaldehyde is often supplied as stable dimeric solid, commonly identified as 2,5-dihydroxy-1,4-dioxane.
N,N-Diisopropylethylamine (DIPEA), also known as Hünig’s Base, is a sterically hindered tertiary amine. It is a colorless liquid with a strong amine odor and is widely used as a low nucleophilic organic base in pharmaceutical, agrochemical, and fine chemical synthesis. Due to its bulky structure, DIPEA effectively scavenges acids without participating in unwanted side reactions.
As a result of the amendment of the CLP Regulation (Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures), new hazard classes have entered into force.