October 2024 – Contents
Chemistry, manufacturing and controls: accelerating development and boosting innovation
Breaking barriers: the future of CMC powered by AI
CMC regulatory considerations for paediatric formulation development
A comparative analysis between ICH Q2(R2) and ICH Q14
Revolutionising compliance with DADI: a new frontier for digital integration
Small interfering RNA: regulatory challenges and therapeutic potential
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WHO Pandemic Agreement gains signatories
The President of UNITE signs statement in support of the World Health Organization (WHO) Pandemic Agreement
Regulators publish new guidelines for use of AI
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.
New Editor-in-Chief for Regulatory Rapporteur
Victoria Goff has been announced as the new Editor-in-Chief of Regulatory Rapporteur.
More news
NICE and EMA say new Alzheimer’s drug is ‘not recommended’
The new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.
Gene therapy restores hearing in five children
Five children with hereditary deafness have had their hearing restored in both ears through gene therapy in a clinical trial.
RegRapPod − June 2024
Vol.21 #6: In June 2024’s RegRapPod, host Alan Booth talks to Issue Editor Davina Stevenson about access to medicines
RegRapPod − In Conversation with Bengt Mattson
BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson
Regulatory Rapporteur - September 2024
September 2024 – Contents
The complexities of botanical regulation
Botanicals and digestive enzymes demonstrate the complexity and diversity of food supplement regulations in the European Union
Introduction to cannabinoids: understanding UK regulation, structure, industry dynamics and charting the future
Borderline products and self-care in the digital age
What are the future prospects for antimicrobial agents?
Navigating drug registration in China: accelerated review policies and pathways
Sustainability and personal care: a regulatory view
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May 2024 – Contents
Unlocking a new paradigm of healthcare through advanced therapies
Dr Peter Marks on reflecting innovation through FDA regulation
The first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Cell gene therapy: clinical trial application procedure of CAR-T therapy in the EU
Near-term challenges of advanced therapy medicinal products: a maturing product class
Navigating the process complexities and challenges associated with EU-CTR transition applications
The European Association of Authorised Representatives
Medical device standards update: March 2024
RegRapPod − In Conversation with Helena Corte-Real
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February 2024 – Contents
Sink or swim: the changing tides of device regulation
AI meets medtech:
big opportunities
require a
measured approachEU MDR implementation – what is changing for the medical device industry?
Chemical characterisation: a critical first step for medical device development
The rise of FemTech and why compliance is key to its success
Overview of medical device regulations in Canada
China drug master file: registration pathways and requirements
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November 2023 – Contents
Editorial - November 2023
Overview of importation
strategy from an
FDA perspective
– PLAIR vs FTZA harmonised approach to clinical data standards
Controlled substances development – past, present, and future
Access consortium: in the current submission transmission ecosystem
Transitioning from paper to electronic IFU for EU MDR 2017/745
Medical device standards update: November 2023
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July/August 2024 – Contents
Sustainable pharmaceuticals
EMA revises the guideline for environmental risk assessment of medicinal products for human use
The sustainability imperative for the healthcare sector
The relevance of sustainability in regulatory affairs consultancies
UK ePI Task Force evidence review: electronic patient information leaflets (ePILs)
E-labelling: revolutionising the labelling landscape
Bengt Mattson reflects on sustainability
Sustainable design and manufacture in medical devices
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April 2024 – Contents
Improving outcomes with data
Data quality, governance and sharing to enable insights and decision-making
Unveiling the synergy of AI’s regulatory harmony in shaping the future of biopharmaceutical progress
Device submissions for combination products: a data-driven perspective
Navigating the future of medicinal product data exchange: understanding XEVMPD
Choosing the right registration pathway for the China drug master file: an essential analysis of options
Managing risks: successful clinical development in asthma
RegRapPod − April 2024
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January 2024 – Contents
The increasing complexity of biological medicinal products
Navigating early drug development investment: a detailed guide to due diligence
A weight of evidence approach for the non-clinical evaluation of complex biologicals
Innovating and harmonising access and requirements amid the global regulatory challenges of biologics
Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
The changing face of oncology development – is cancer still ‘different’? A US perspective
Artificial intelligence in drug discovery
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October 2023 – Contents
Veterinary medicines: the challenges of new regulation
Transition to the new QRD template for veterinary medicines: challenges and opportunities
Autogenous vaccines under Regulation (EU) 2019/6
Prequalification of veterinary vaccines and medicines
EMA activities related to antiparasitic veterinary medicinal products
Optimal materials selection in medical device development – a proactive biocompatibility approach
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June 2024 – Contents
The global access battle for healthcare equity
Project Orbis – a sponsor’s perspective on the collaborative international review process
A key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation
The availability of medicines post-Brexit in Malta
Opportunities and challenges in the Latin American pharmaceutical industry
The UK Responsible Person Association
Over two years into the new veterinary medicines rules for the EU: a reflection on where we are now
Comparing China Drug Master Files with the EU and US
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March 2024 – Contents
Diverse and dynamic regulation in the Asia Pacific region
Navigating the regulatory terrain down under: trends in Australia for 2024
Regulatory imperatives in chemistry, manufacturing, and control for biosimilars a comprehensive analysis
Can the Japanese phase I study be waived?
Overview of digital transformation in healthcare and initiatives in Japan
Clinical trial design – keeping up with innovation
New data protection for maximum residue limits
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December 2023 – Contents
Advancing global
healthcare togetherHM1: Update on EU new regulatory legislation − EMA, industry and others
HM2: Improving the odds of regulatory success
PS1:
Health technology assessment –
the new EU regulationVM1:
Horizontal legislation and
veterinary medicine availabilityVM2: New initiatives in regulatory science
MD2/IVD2:
Medical technologies −
a catalyst for
regulatory innovationsIVD3: IVDR: Current state
TOPRA Annual lecture
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September 2023 – Contents
The worldwide web of regulation
Q&A:
Navigating the
pharmaceutical supply chainNavigating the global supply of starting materials for cell-based therapies
Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Biosimilars CMC development considerations from the sponsor perspective
Warning letters for direct-to-consumer advertising: a five-year retrospective analysis
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Editor's pick
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Australian PM makes thalidomide apology on 62nd anniversary
ICMRA regulators to mark its 10th year at event in Australia
European Parliament gives first stage approval for revised EMA fees
Northern Ireland deal permits GB medicines but not medical devices
UK set to accept CE mark for medical devices until 2028
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