Regulatory Blog

The European regulatory framework continues to strengthen data protection and transparency  in its international collaborations, particularly when engaging with EU candidate countries. As part of this effort, the European Medicines Agency (EMA) has established clear guidelines on how personal data is processed within cooperation programmes. The guidance European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (I

The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices  was published on 31 March 2026 , outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice. Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evi

The European Medicines Agency (EMA) has introduced two significant guidance updates in 2026, focusing on active substance chemistry requirements  and the emerging use of additive manufacturing (3D printing) in pharmaceuticals . These updates aim to strengthen quality, control strategies, and innovation , while ensuring that pharmaceutical development and manufacturing remain scientifically robust and patient-focused. Guidance: Chemistry of Active Substances Scope and Regulato

Regulatory authorities across the European Union continue to strengthen pharmacovigilance systems and data-driven regulatory decision-making. Two important EMA documents highlight these developments: the EU implementation strategy for the ICH E2D(R1) guideline on post-approval safety data  and the Network Data Steering Group (NDSG) Workplan 2026–2028 on data and artificial intelligence in medicines regulation. Guidance: Network Data Steering Group Workplan 2026–2028: Data and

Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel

Medicine shortages can have a direct and serious impact on patient care, healthcare systems, and public health across Europe. To strengthen coordination, improve visibility, and enable early action, the European Medicines Agency (EMA) has established the European Shortages Monitoring Platform (ESMP) . The ESMP is a central digital platform designed to support the prevention, identification, monitoring, and management of shortages of medicinal products across the EU and EEA.

Radiopharmaceuticals present unique quality challenges due to their radioactive nature, short shelf lives, and frequent need for on-site or near-patient preparation. To reflect scientific and technological advances since the original 2007 guideline, the European Medicines Agency has released the draft Guideline on quality of radiopharmaceuticals – Revision 2  for public consultation. Adopted by CHMP in December 2025, this revision provides updated expectations for quality doc

Modern medicines development increasingly sits at the intersection of advanced chemistry and genomic science. On one hand, synthetic peptides represent a fast-growing therapeutic class that bridges small molecules and biologics. On the other, pharmacogenomics is reshaping how medicines are developed, evaluated, and ultimately used in patients. Recognising these parallel advances, the European Medicines Agency (EMA) has recently published two key scientific documents: the Guid

Post-authorisation changes are an inevitable part of medicinal product lifecycle management, and stability data play a critical role in demonstrating that such changes do not compromise product quality, safety, or efficacy. To harmonise expectations across the EU, the European Medicines Agency has issued Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorisation . Adopted in December 2025 and effective from January 2026, this

Regulatory teams responsible for lifecycle management know that post-authorisation changes can quickly become complex, especially as products mature, manufacturing processes evolve, and emerging scientific data require frequent updates to quality and clinical documentation. To support consistent interpretation of EU Variation Regulation (EC) No 1234/2008, the European Medicines Agency (EMA) maintains an extensive Q&A document titled " Classification of Changes " —a practical

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...