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.
A significant uptick in M&A activity in the biosimilars sector is being driven by FDA regulatory reforms, a maturing patent litigation framework and a looming patent cliff — $200 billion of branded products are facing patent expiration by 2030.
The Drewry World Container Index edged lower this week as falling Asia-Europe rates outweighed firmer pricing on the Transpacific, with carriers preparing another round of blank sailings ahead of China’s Golden Week holiday.
Diacetone Alcohol (DAA) is an aliphatic hydroxy ketone produced through the base-catalysed aldol addition of two acetone molecules. It contains both ketone and tertiary hydroxyl functionalities, offering excellent solvency and chemical reactivity.
As a high-boiling oxygenated solvent and valuable chemical intermediate, DAA finds broad application in paints and coatings, printing inks, adhesives, industrial cleaning, cosmetics, and textiles. It is also used as an intermediate in the production of mesityl oxide and MIBK. (4-methylpentan-2-one).