• 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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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 The new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.

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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.

June-24-Podcast-artwork-Spreaker

RegRapPod − June 2024

2024-06-26T10:05:00+01:00By

Vol.21 #6: In June 2024’s RegRapPod, host Alan Booth talks to Issue Editor Davina Stevenson about access to medicines

05-Bengt-Podcast-artwork-Webvision

RegRapPodIn Conversation with Bengt Mattson

2024-05-31T00:05:00+01:00By and and 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

  • 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

  • RegRapPodIn Conversation with Helena Corte-Real

  • February 2024 – Contents

  • Sink or swim: the changing tides of device regulation

  • AI meets medtech:
    big opportunities
    require a
    measured approach

  • EU 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

  • November 2023 – Contents

  • Editorial - November 2023

  • Overview of importation
    strategy from an
    FDA perspective
    – PLAIR vs FTZ

  • A 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • December 2023 – Contents

  • Advancing global
    healthcare together

  • HM1: Update on EU new regulatory legislation − EMA, industry and others

  • HM2: Improving the odds of regulatory success

  • PS1:
    Health technology assessment –
    the new EU regulation

  • VM1:
    Horizontal legislation and
    veterinary medicine availability

  • VM2: New initiatives in regulatory science

  • MD2/IVD2:
    Medical technologies −
    a catalyst for
    regulatory innovations

  • IVD3: IVDR: Current state

  • TOPRA Annual lecture

  • September 2023 – Contents

  • The worldwide web of regulation

  • Q&A:
    Navigating the
    pharmaceutical supply chain

  • Navigating 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

  • 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