Regulatory Rapporteur September 2026 – Contents
Asia-Pacific: A changing regulatory landscape
Managing ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific
Navigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations
Navigating the Australian Office of the Gene Technology Regulator: A regulatory affairs perspective on clinical trials involving genetically modified organisms
Pathways to medicine registration in Australia
Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S
Modernising India’s drug submissions: Embracing eCTD 4.0 for international regulatory alignment
From regulation to implementation: Medical device serialisation and traceability in India
China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
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FDA launches final guidance on therapeutic equivalence evaluations
The US Food and Drug Administration (FDA) has issued its final guidance on making therapeutic equivalence evaluations and assigning therapeutic equivalence (TE) codes.
FDA consults on the regulation of GenAI-enabled medical devices
The US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
FDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
More news
New diabetes treatment and a Vetmedin referral: Inside the CVMP July 2026 meeting
The July meeting of the Committee for Veterinary Medicinal Products (CVMP) covered product opinions, a Union referral, scientific advice outcomes, and several guideline updates spanning fixed combinations, novel RNA-based therapies and pharmacovigilance.
CHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough
At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
CVMP June 2026 meeting update: Vaccines, guideline reviews and an AMR strategy refresh
The Committee for Veterinary Medicinal Products (CVMP) met on 16-18 June 2026. Alongside its usual product decisions, the Committee advanced two guideline reviews for sponsors working on vaccines and other immunological products.
FDA launches new guidance on development of psychedelic drugs to treat medical conditions
The US Food and Drug Administration (FDA) has issued its final guidance for drug development programmes evaluating the therapeutic potential of psychedelic drugs.
RegRapPod − InConversation with TMC Pharma
InConversation talks about conditional marketing authorisation − and how the work starts after approval – with Catherine Moncad
RegRapPod − InConversation with Aman Khera
InConversation talks about opportunities and disruptors within the regulatory affairs industry with Aman Khera
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