Regulatory Blog

The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...

In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...

On June 19, 2025, the Medical Device Coordination Group (MDCG), in collaboration with the Artificial Intelligence Board (AIB) of the...

The International Council for Harmonisation (ICH) has taken a major step toward modernizing clinical trial designs with the release of the...

Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....

The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...

To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA) is actively implementing...

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...

In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...

As the role of real-world data (RWD)  and real-world evidence (RWE)  grows in drug development, regulatory decision-making, and...

In the ever-evolving landscape of medical device regulation, the Periodic Safety Update Report (PSUR)   plays a pivotal role in ensuring...

In recent years, the MHRA has issued several key guidance documents strengthening the lifecycle safety and regulatory oversight of...

Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....

The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...

The U.S. Food and Drug Administration (FDA) has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...

The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...

The post-Brexit regulatory landscape for medical devices in the UK has brought significant changes, particularly in Northern Ireland,...

In recent years, GLP-1 receptor agonists have gained widespread attention for their dual role in type 2 diabetes management and weight...

In the evolving landscape of pharmaceutical manufacturing, Decentralised Manufacture  has emerged as a pivotal approach, especially in...

The South African Health Products Regulatory Authority (SAHPRA) has released the sixth version of its Biological Medicines Amendment...