• April 2024 – Contents

  • Improving outcomes with data

  • Data quality, governance and sharing to enable insights and decision-making

  • Revolutionising drug development: 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 and its crucial role in regulatory compliance

  • Managing risks: successful clinical development in asthma

  • Choosing the right registration pathway for the China drug master file: an essential analysis of options

More news

E. coli growing in a petri dish

Radio waves used to hijack E.coli bacteria to make medicines

Researchers have developed a method that uses high-frequency radio waves to temporarily open bacterial cell walls to introduce new DNA.

Sponge-on-a-string cuts wait time for Barrett’s diagnosis

A procedure to test for a precancerous condition of the oesophagus, which uses a novel medical device, is under trial in NHS England.

MHRA reclassifies codeine linctus as prescription-only

Over-the-counter cough syrups which contain the opioid codeine have been reclassified as prescription-only medicines due to the risk of abuse.

Violin resin works as cleaning agent for ‘superbugs’

A form of resin taken from a Norway spruce has been found to also function as an effective disinfectant against drug-resistant bacteria.

Angioedemas caused by rare gene fault curable by CRISPR

A single dose of a CRISPR gene therapy has been shown to almost eliminate a rare genetic, inflammatory and potentially life-threatening condition.

Apr-24-Podcast-artwork-Webvision

RegRapPod − April 2024

2024-04-13T00:05:00+01:00By

Vol.21 #4: In April 2024’s RegRapPod, host Alan Booth talks to Issue Editor James McCormick about all things data.

RegOpsSPIN-Podcast-artwork-Webvision

RegRapPodIn Conversation with TOPRA’s RegOps SPIN

2024-02-02T00:05:00+00:00By

BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN

  • 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

  • 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

  • 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

  • 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

  • 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