January 2025 – Contents
Biologics development: Overcoming regulatory hurdles
Considerations for generics developers moving into the field of biosimilars
Unique aspects of biologic reference standards
Considerations in the development of allogenic and autologous cell therapies
Addressing the challenges of implementing the common technical document in Brazil
Overview of chemical generics registration in China: Challenges for overseas applicants
The role of artificial intelligence in regulatory affairs
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MHRA issues guidance on post-market surveillance regulation in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation
FDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
ICH releases M15 Guideline on Model-informed Drug Development
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M15 Expert Working Group has developed a draft guideline on model-informed drug development (MIDD) and is now under public consultation.
More news
GSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
According to a report by GSK, a recent clinical trial has revealed that Blenrep can reduce the risk of death by 42% in multiple myeloma after relapse.
Greater post-market surveillance for medical devices
New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
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 - January 2025
January 2025 – Contents
Biologics development: Overcoming regulatory hurdles
Considerations for generics developers moving into the field of biosimilars
Unique aspects of biologic reference standards
Considerations in the development of allogenic and autologous cell therapies
Addressing the challenges of implementing the common technical document in Brazil
Overview of chemical generics registration in China: Challenges for overseas applicants
The role of artificial intelligence in regulatory affairs
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Regulatory Rapporteur - October 2024
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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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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Regulatory Rapporteur - December 2024
December 2024 – Contents
North America:
Navigating key regulatory updatesNotable US Food and Drug Administration pilot programmes
Health Canada: Points to consider when preparing quality and new substance notification documentation for investigational medicinal products
Shedding light on essential drug delivery outputs
Transitioning to the Clinical Trials Regulation: The Roche experience
Medical device standards update: December 2024
Early development of vaccines and prophylactics in infectious diseases: A post-pandemic regulatory overview
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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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Regulatory Rapporteur - November 2024
November 2024 – Contents
Improving health outcomes through regulatory excellence
November 2024 – Contents: Human medicines sessions
November 2024 – Contents: Medical devices/IVDs sessions
November 2024 – Contents: Veterinary medicines sessions
PS1: Resolving specific development hurdles via scientific advice
PS2: Patient experience data – The next steps towards medicines evaluation
SME: Regulatory updates for SME, academia and start-ups
TOPRA annual lecture: Status of global health
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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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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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