How Do You Choose Partners to Develop the Product?
Harmonisation and legislation (20 min)
The International Committee for Harmonisation of Standards (ICH) started 20 years ago with US, European Union and other western countries, initially harmonising standards between FDA and EMA but now increasingly trying to address standards in other regions and countries. There are annual International Conferences for Drug Regulatory Authorities to provide a forum for collaboration and an ICMRA project currently with a limited group of regulatory authorities looking at possibilities for solving challenges that affect multiple and different regions and countries.
The IMDRF are working on harmonised standards for devices and there is an interesting perspective on key differences from two surgeons who have worked with both sets of regulators
Whilst they are investigating a soft approach which allows individual countries some independence in how standards may be applied, the complexity of multiple participants in manufacturing and supply chains including international companies affect how these could be applied without penalising smaller researchers and developers who may not have regular access to suitable facilities, equipment, chemicals and packaging.