Regulatory Rapporteur

Regulatory Rapporteur is our respected international peer-reviewed journal which is published 11 times per year and available free to TOPRA members. Each issue focuses on a particular subject area and includes articles and interviews, alongside a periodic CPD supplement.

In addition to its print edition, the journal’s content is now published in a fully online format. With a wide range of features, including intuitive search tools and improved accessibility, these will enable Regulatory Rapporteur to maintain its role as a leading source of knowledge and expertise for the global regulatory affairs community.

November 2022 issue

Focus: North America - Regional influences shaping innovations in regulatory affairs

Members-only articles

Focus articles: North America 

  • Breakthrough therapy designation - From serious diseases to opioid crisis prevention
  • The power of collaboration
  • Health Canada: Regulatory Highlights 2021-2022

Other articles:

  • The worldwide acceptance of non-legalised eCPPs
  • US FDA CDER and CBER guidance of interest
  • Medical device standards update

Use the issue archive below to download the complete issue as a PDF or to access individual articles or complete issues going back to 2015.

Note: To access members-only content, you must be logged in to the site with your TOPRA Member account.

 

Free articles
Editorial: Adapting, transforming and innovating (PDF download)

To read the current issue of Regulatory Rapporteur in its entirety, plus receive access to every issue going to back to 2015, join TOPRA today.

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Issue archive

Non-members may access select articles per issue. Join TOPRA to get full access to our journal and CPD content.

Search the archive  (TOPRA Membership required for full archive access)

Archived issues earlier than 2015

If you require Regulatory Rapporteur articles or back issues published prior to 2015, please email publications@topra.org.

Articles for purchase

For information about purchasing journals, articles or reprint licences, contact us at publications@topra.org

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Latest Issues
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Show all 87
Volume: 19
Issue: 10

In This Issue:
North America: Regional influences shaping innovations in regulatory affairs
Plus:
The worldwide acceptance of non-legalised eCPPs
US FDA CDER and CBER guidance of interest
Medical device standards update
Volume: 19
Issue: 09

In This Issue:
Medical technologies: Navigating the shifting landscape of medical device regulation
Plus:
Inclusion of older people in drug development and clinical trials: Part 2
The health economics profile of new pharmaceuticals
Volume: 19
Issue: 08

In This Issue:
Regulatory operations: Essential emerging trends for regulatory operations professionals
Plus:
RX to OTC: EU reclassification regulatory framework - what are the key challenges and how might these be overcome? Part 2
Inclusion of older people in drug development and clinical trials: Part 1
Harmonising regulation of medicinal allergen products throughout the European Union - the historic situation and subsequent CMDh guidance
Volume: 19
Issue: 07

In This Issue:
Data governance: How industry is managing data in an era of advancing technology
Plus:
One year experience on EU MDR 2017/745 for single integral drug-device combination products
Antibiotics in
biopharmaceutical production
EU reclassification (Rx to OTC switch) regulatory framework
Volume: 19
Issue: 06

In This Issue:
Pharmacovigilance legislation - Exploring the impact of pharmacovigilance legislation on human medicines
Plus:
Interview: Updates to quality legislation from the EMA
Article: Medical device standards update
Interview: Evolutions in patient healthcare at the MHRA
Article: Exploring Amgen's Project Orbis experience with sotorasib
Article: What can past decision-making data tell us about how the FDA will make future combination product categorisation decisions?
Volume: 19
Issue: 05

In This Issue:
Chemistry, manufacturing and controls – Ensuring safe and effective pharmaceutical products
Plus:
Article: Procedure withdrawals in Europe: past trends, impact and communication recommendations
Article: Amgen’s experience of global expedited regulatory pathways in the development of sotorasib
Volume: 19
Issue: 04

In This Issue:
Green Pharma - Exploring the green initiatives transforming the industry
Plus:
Interview: A review of paediatric development challenges, FDA collaboration and future trends
Article: Brexit: The regulatory landscape one year on
Meeting report: The DIA's accelerating CMC workshop
Volume: 19
Issue: 03

In This Issue:
The UK post-Brexit: The future of the UK after Brexit
Plus:
• Article: Navigating the regulatory landscape for regenerative medicines in Japan
• Article: A review of Project Orbis: An initiative enabling faster patient access to cancer therapies
• Article: Hype over hemp as a veterinary feed additive?
Volume: 19
Issue: 02

In This Issue:
Expedited pathways: How expedited pathways benefit patients and the industry
Plus:
• Article: Selection and justification of regulatory starting materials
• Interview: Building best regulatory practices in Brazil
• Meeting Report: The EMA’s Veterinary Big Data Stakeholder Forum (Part 2)
Volume: 19
Issue: 01

In This Issue:
Advances in Clinical Trials: Innovative approaches to promoting diversity and patient access via technology

Plus:
• Article: A regulatory lens on an industry imperative: Diversity in clinical research
• Interview: Facilitating the use of information to improve global health
• Meeting Report: The EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
Volume: 18
Issue: 12

In This Issue:
Focus: TOPRA Annual Symposium 2021
- Revolution in Regulatory Affairs: How the pandemic is shaping regulatory science
Plus:
Pharmaceutical: Human Medicines Symposium
Medical Devices: Medical Devices/IVDs Symposium
Veterinary: Veterinary Medicines Symposium
Volume: 18
Issue: 11

In This Issue:
Focus: US Regulatory Update- US emergency preparedness and response to the pandemic
Plus:
France implements major changes in its early access framework
Interview: Regulations of medicines in Denmark
Meeting Report: Stakeholders input into EU standards for data sharing
Volume: 18
Issue: 10

In This Issue:
CPD; Digital health technologies:
EU/US frameworks

MEETING: EMA/AnimalhealthEurope
Info Day

INTERVIEW: Erik Hansson, former Deputy
Head of Unit, EC
Volume: 18
Issue: 09

In This Issue:
MENA/Africa region: Delving into the regulatory framework of this diverse and growing region
Plus
Interview: Irena Storová – Director of SUKL, Czech Republic
Labelling: Insights on requirements in the Middle East and Africa
Decentralised clinical trials: Flexibilities adopted by regulators during COVID-19
Volume: 18
Issue: 07

In This Issue:
Pain management
Regulatory considerations in pain treatments for humans and animals

Plus:
Storyboarding Meetings - Why they are useful for marketing applications
Meetings - EMA/HMA webinar on artificial intelligence
IDMP- Business benefits of implementing a new RIMS
Volume: 18
Issue: 06

In This Issue:
Focus: Data Transparency - The challenges of disclosing adequate clinical trial information in a comprehensible format

Plus:
• ATMPs - How to obtain positive HTA recommendations
• ICH Q12 - Flexible management of post-approval changes
• Veterinary Medicines - EMA's veterinary data strategy explained
Volume: 18
Issue: 05

In This Issue:
Focus: OTC/Consumer products - Why regulatory flexibilities are needed in an evolving
landscape for minor ailments and self-care

Plus:
• Rolling Reviews - How they effectively speed up the review process
• EU Veterinary Regulations - Impact on medicines availability and AMR
• Medical Technologies - Latest medical device/IVD standards update
Volume: 18
Issue: 04

In This Issue:
Focus: Nonclinical studies - Laying the foundations for the development of new pharmaceutical compounds

Plus:
• Interview - Alex Nolte, head of EMA's human medicines division
• Artificial intelligence - Discovering solutions for better patient outcomes
• The 3Rs - Designing studies with juvenile animals
Volume: 18
Issue: 03

In This Issue:
Focus: Regulatory Intelligence - Processing targeted information and data to generate a meaningful output

Plus:
• CMC: Impurity management in clinical studies
• INTERVIEW: Celebrating 30 years of ICH harmonisation efforts
• MEETING REPORT: Advancing CMC workshop: Global challenges
Volume: 18
Issue: 02

In This Issue:
Focus: Asia Pacific - Examining regulatory issues in the far east continent and beyond
Plus:
• COSMETIC PRODUCTS: Navigating the rules on advertising claims
• ATMPs: Regulation of advanced therapies in the US
• IDMP AND THE SPOR INITIATIVE: What these are and why they are important