Regulatory Blog

The European Medicines Agency (EMA) recently published new guidance titled “ Guidance for applicants: the ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA ) ”, outlining how sponsors and applicants can benefit from harmonised scientific advice to accelerate clinical trial authorisation across the EU. 1. What the SA-CTA Scientific Advice Is The guidance explains that the SA-CTA scientific advice is a specialised type of EMA advice developed under th

The European Medicines Agency (EMA) has released a major draft guideline " Non-Inferiority and Equivalence Comparisons in Clinical Trials "  that updates how non-inferiority and equivalence comparisons should be designed, justified, and analysed in confirmatory clinical trials. This draft replaces two earlier documents: Guideline on the choice of the non-inferiority margin  (2005), and Points to consider on switching between superiority and non-inferiority  (2000). The new gu

In October 2025, the European Medicines Agency (EMA) released two landmark drafts for public consultation. These documents collectively signal the Agency’s evolving regulatory stance toward precision biologics such as bacteriophage therapy and innovative device–drug integration approaches to simplify clinical bridging for biologics delivered subcutaneously. 1. Quality Guidance for Phage Therapy Medicinal Products (PTMPs) The EMA draft guideline on phage therapy quality (Oct

On 22 September 2025 , the European Commission published new variations guidelines  in the Official Journal of the European Union. These...

In 1st & 8th August 2025, the European Medicines Agency (EMA) announced two major milestones in the transition to electronic Common...

On 8 August 2025 , the European Medicines Agency (EMA) published the latest revision (Rev. 14) of its "Procedural Advice on Paediatric...

The European Medicines Agency (EMA)  submitted its updated report to the European Commission (EC)  evaluating the feasibility of...

On 25 July 2025 , the European Medicines Agency (EMA) published the latest guidance " Procedural Advice on Paediatric Applications " ....

On 14 July 2025 , the European Medicines Agency (EMA) published the final revised guideline  titled " Guideline on the requirements for...

On 18 July 2025, the European Commission published detailed Guidelines on the scope of the obligations for providers of general-purpose...

In a world where artificial intelligence (AI) is moving rapidly from theory to practice, regulators are tasked with keeping pace—not only...

The European Medicines Agency (EMA) provides structured guidance for sponsors aiming to secure orphan medicinal product designation...

In the ever-evolving regulatory landscape of EU pharmaceuticals, digital solutions are a linchpin for timely and transparent scientific...

In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...

In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...

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

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

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

Human normal immunoglobulin (IgG) products administered via the subcutaneous (SCIg) or intramuscular (IMIg) route are essential...

Pharmacovigilance is critical for ensuring drug safety in the EU. EudraVigilance is the central system operated by the European Medicines...