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Biologics articles

ICH Q6(R1): Harmonising specifications for chemical and biological products

2026-10-07T10:14:00+01:00By Francisco Baptista and Marta Silva

ICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines

By Janine Jamieson, Carolyn Gordon and Andrew Lennard
Central sourcing of authorised comparators and concomitant medications for multiregional clinical trials in accordance with ICH E17: CMC documentation requirements

By John Watkins, Morgane Lejeune and Pascha Clark-Higgs
A comparative analysis between ICH Q2(R2) and ICH Q14

By Rajendra Kunda, Slobodanka Cirin-Varadjan, Rick Best, Hao Liu and Srinivas Yerraguntla

Navigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations
2026-09-02T14:51:00+01:00
Managing ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific
2026-09-02T10:58:00+01:00
Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
2026-06-30T14:20:00+01:00
Regulatory Rapporteur March 2026 – Contents
2026-03-06T09:18:00+00:00
The innovation era: Where biology meets technology
2026-03-05T17:58:00+00:00
Beyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
2026-03-05T14:52:00+00:00

Navigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
2026-03-04T17:04:00+00:00
Cell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
2026-03-04T15:08:00+00:00
Navigating regulatory pathways for live biotherapeutics in the US and EU: Challenges and opportunities
2026-03-04T12:15:00+00:00
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
2026-02-26T15:22:00+00:00
PS1: Tailored development of biosimilars without efficacy and safety studies – Is this the future?
2025-11-18T09:58:00+00:00
HM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development
2025-11-18T09:57:00+00:00