Over last 40 years Pharmaceuticals has aligned around The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines as they have developed and there is now harmonisation of development approaches for new medicines across the world. This means that the standards and requirements for product quality, clinical trials, and non-clinical safety assessment are standardised and the data obtained can be accepted globally provided the activities are compliant with Good Manufacturing Practices for Quality Standards (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines and clinical studies contain representative patient populations to support worldwide use. The major advantage is that development activities do not need to be repeated for different markets, so if you do a clinical trial in e.g., In Europe, if it is to GCPs standards with appropriate representative patient cohorts any regulatory agency in the world will accept it. This means that new effective medicines can be brought to patients quicker, allowing patient benefits can be realised.
On the other hand, tobacco regulations are not harmonised and can somewhat be contradictory between different countries. Whilst some countries are developing rigorous standards for quality requirements and safety assessments e.g., USA, whereas in other countries there yet, are no defined guidelines. However, there is the opportunity to shape how the regulations evolve so that development activities we deliver, work towards mutual recognition and harmonisation, so the work done can be suitable for any market application in the nicotine consumer space – whether its Tobacco Product Directive (TPD) or Premarket Tobacco Product Application (PMTA) or Modified Risk Tobacco Product (MRTP) – this would both encourage innovative approaches and would consistently bring safer products to consumers whilst supporting a smokeless future.
What are your thoughts on the global harmonisation of ENDS?