Regulatory Blog

In January 2026, the South African Health Products Regulatory Authority (SAHPRA) issued an important communication to stakeholders regarding Type II variation applications submitted under the Type II Pilot Programme. The update provides clarification on submission window compliance and temporary fee processing arrangements due to a system-related pricing limitation in the SAHPRA Engagement Portal. Background and Context SAHPRA acknowledged that certain applicants experienced

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

The integration of modeling and simulation into drug development has evolved from a supportive analytical tool to a central pillar of regulatory decision-making. Recognising this shift, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has formally adopted ICH M15: Guideline on General Principles for Model-Informed Drug Development (MIDD)  at Step 5 . The guideline was: Endorsed under Step 2 on 6 November 2024 Adopted by r