Regulatory Blog

In February 2026, Swissmedic published updated guidance documents covering key regulatory and post-authorisation requirements for human medicinal products. These updates provide clarity on administrative changes, pharmacovigilance obligations, formal submission requirements, packaging standards, document protection, parallel import procedures, co-marketing authorisations, lifecycle management, and variations. Guidance: Change of Name or Domicile of the Authorisation Holder Th

The Guide for National Scientific and Regulatory Advice  issued by the Health Products Regulatory Authority (HPRA) outlines the framework for obtaining national scientific and regulatory advice to support the development of new or existing human medicinal products. The objective of this advice is to guide applicants in their development programmes; however, it does not replace or substitute the applicant’s legal and regulatory responsibilities in the development of their medi

Developing innovative medicines requires early, structured engagement with regulators. The UK’s Integrated Scientific Advice (ISA)  service provides coordinated, multidisciplinary guidance to help applicants generate robust evidence and navigate regulatory requirements efficiently. What is Integrated Scientific Advice (ISA)? Integrated Scientific Advice (ISA)  is a coordinated regulatory advice service that brings together expertise from across the UK regulatory landscape. I