Regulation related to the development, registration and monitoring of medicinal products has developed at different paces in regions of the world, but the most quoted trigger for ‘modern’ drug regulation is the thalidomide tragedy of the mid-20th century. In the past decades a lot of progress has been made in the application and evolution of regulatory legislative procedures for the benefit of patients and public health but also in driving and enabling innovation.
Medicines development is a global endeavor and exchange of experience and knowledge between regulatory agencies working under different jurisdictions is not only necessary but seen increasingly as essential.
There are several factors playing a role in this process:
• Patients are increasingly well informed about their disease, existing treatments, and novel developments on the horizon, and share information with others across regions.
• Scientific progress is facing a rapid development with impressive achievements in medicine, pharmacology, basic science, and technical disciplines. With this we also face several novel challenges inherent with the possibilities that technology can provide (e.g. whole genome sequencing, AI, etc.).
• Regulatory bodies are facing new challenges with decisions to be made faster for the sake of not delaying the availability and access to newly developed treatments. The COVID-19 crisis has only reiterated the need for collaboration, coherence, and solidarity on a global scale.
With this in mind, we as guest editors are opening a research topic which is intended to invite experts from around the globe to contribute their views on the regulation of medicines today and in the future.
More specifically we expect manuscripts related to the following topics:
• Summary of the key aspects of the 3 main regulatory frameworks globally - USA, Europe and Japan commonalities and differences Future changes to EU legislation - case study of drivers for change
• Global trends in regulatory science that impact legislation, drug development and patient access
• The importance of regulatory collaboration and harmonization and the role of not for profit organizations
• Emerging regulatory frameworks - Africa, Latin America and the ROW
• Reliance regulation - pros and cons - is this the direction of travel?
• Novel regulatory procedures – case studies of innovation in regulatory practice
• Future proofing the regulatory framework and the role of horizon scanning
• Scientific advice and other regulatory support tools
• Clinical trials, centralized versus decentralized?
• Digital revolution – impact of AI and ML
• Drug device combinations
• Specific regulatory pathways for innovative medicines
• Possibilities for regulatory convergence
Type of articles expected (but not limited to) are:
• Original articles,
• Reviews
Regulation related to the development, registration and monitoring of medicinal products has developed at different paces in regions of the world, but the most quoted trigger for ‘modern’ drug regulation is the thalidomide tragedy of the mid-20th century. In the past decades a lot of progress has been made in the application and evolution of regulatory legislative procedures for the benefit of patients and public health but also in driving and enabling innovation.
Medicines development is a global endeavor and exchange of experience and knowledge between regulatory agencies working under different jurisdictions is not only necessary but seen increasingly as essential.
There are several factors playing a role in this process:
• Patients are increasingly well informed about their disease, existing treatments, and novel developments on the horizon, and share information with others across regions.
• Scientific progress is facing a rapid development with impressive achievements in medicine, pharmacology, basic science, and technical disciplines. With this we also face several novel challenges inherent with the possibilities that technology can provide (e.g. whole genome sequencing, AI, etc.).
• Regulatory bodies are facing new challenges with decisions to be made faster for the sake of not delaying the availability and access to newly developed treatments. The COVID-19 crisis has only reiterated the need for collaboration, coherence, and solidarity on a global scale.
With this in mind, we as guest editors are opening a research topic which is intended to invite experts from around the globe to contribute their views on the regulation of medicines today and in the future.
More specifically we expect manuscripts related to the following topics:
• Summary of the key aspects of the 3 main regulatory frameworks globally - USA, Europe and Japan commonalities and differences Future changes to EU legislation - case study of drivers for change
• Global trends in regulatory science that impact legislation, drug development and patient access
• The importance of regulatory collaboration and harmonization and the role of not for profit organizations
• Emerging regulatory frameworks - Africa, Latin America and the ROW
• Reliance regulation - pros and cons - is this the direction of travel?
• Novel regulatory procedures – case studies of innovation in regulatory practice
• Future proofing the regulatory framework and the role of horizon scanning
• Scientific advice and other regulatory support tools
• Clinical trials, centralized versus decentralized?
• Digital revolution – impact of AI and ML
• Drug device combinations
• Specific regulatory pathways for innovative medicines
• Possibilities for regulatory convergence
Type of articles expected (but not limited to) are:
• Original articles,
• Reviews