Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will it impact both the sponsors and health authorities alike?
An introduction to the Regulatory Product Submission Standard
The short answer is the Regulatory Product Submission or RPS which is a Health Level Seven (HL7) standard, and has been in development for many years already; since June 22nd 2005 to be precise. The good news is that the new standard is being developed with input from all sides that will be affected: the global health authorities themselves providing input into how the information should best be best provided to them; the sponsors to provide feedback on how those changes would impact their businesses; and the technology solution providers to ensure that whatever is agreed is feasible from a solution perspective. This collaborative approach to the design should make for a less painful adoption of the standard compared to the original eCTD for example.
The life sciences industry has taken on board as many lessons learned from the implementation of the current eCTD standard, and is delivering a new ideology for the sharing of information between sponsor and health authority. This new approach will improve many of the shortfalls in communication and ultimately help ensure that new products are brought to market as quickly and efficiently as possible in the future, to the benefit of all parties including, at the end of the day, the general public.