The Investigational Medicinal Product Dossier

The answer is not to dump every bit of information you have into your IMPD. Your focus should be on providing the information necessary to establish that the product is adequately characterised and controlled for the proposed exposure, supported by an appropriate non-clinical package and a scientifically justified starting dose.

Most stakeholders tend to be aware and confident of their abilities. However, a medical writer can be extremely useful, particularly when the dossier involves multiple contributors and needs to become a coherent regulatory document. But a medical writer cannot manufacture missing scientific knowledge. The best arrangement is usually multidisciplinary. Subject matter experts generate and interpret the evidence; regulatory specialists determine the applicable requirements; and an experienced writer integrates the information into a consistent narrative. The writer’s job is not simply to make the document readable. It is to make the evidence understandable. That is a different skill.

Since the advent of Brexit an ever more relevant question has been how different are the EU and UK IMPDs. Suffice to say that scientifically, they should ideally be remarkably similar. Regulatorily, they need not be identical. For a multinational development programme, maintaining a controlled core dossier can avoid unnecessary duplication while allowing jurisdiction-specific requirements to be incorporated.

Earlier than many sponsors do. Regulatory advice is particularly valuable when the product, development pathway or manufacturing process creates an unusual problem for which existing guidance does not provide a straightforward answer. The MHRA explicitly states that sponsors can seek scientific advice at any stage of medicine development. The objective should not be to ask the regulator to tell you how to write the development strategy. It is to test the proposed strategy against the regulator’s expectations before an avoidable problem becomes embedded in the programme.