• June 2024 – Contents

  • The global access battle for healthcare equity

  • Opportunities and challenges in the Latin American pharmaceutical industry

  • Project Orbis – a sponsor’s perspective on the collaborative international review process

  • The availability of medicines post-Brexit in Malta

  • 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

More news

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Melanoma vaccine enters Phase III clinical trials

A personalised mRNA vaccine for a deadly form of skin cancer is being rolled out in an international Phase III clinical trial.

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DR Congo mining town sees novel monkeypox strain

A mutation strain of monkeypox has been identified in a mining town in the Democratic Republic of Congo (DRC), according to a preprint paper.

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

May-24-Podcast-artwork-Webvision

RegRapPod − May 2024

2024-05-08T16:30:00+01:00By

Vol.21 #5: In May 2024’s RegRapPod, host Alan Booth talks to Issue Editor Harriet ‘Podcast’ Edwards about her specialist subject ATMPs.

  • 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

  • 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

  • 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