A summary of the outcome of a survey carried out by the CMR International Institute for Regulatory Science among pharmaceutical companies and regulatory agencies.
There was consensus that the regulatory environment has changed over the three years between 2000 and 2003 compared to the late 1990s. Whilst 65% of companies felt that the changes had increased the time and cost in bringing new medicines to market, only 23% thought the changing regulatory environment to be directly responsible for the decline in new active substance (NAS) submissions.
Both companies and authorities share the view that the regulatory agencies have become more risk-averse and are requesting more safety data for compounds compared with the late 1990s.
Most companies believed that there had been an increase in the number of conditions attached to authorisations and a majority were of the view that differences in scientific opinion between regulatory agencies had increased the cost and time of clinical development.
The authorities acknowledged the increase in the rate at which regulatory guidelines have been published and greater stringency in their application. They felt, however, that global development is being facilitated by the increasing harmonisation of regulatory requirements across regions compared with the late 1990s.
The need to develop a risk management plan prior to submission was seen, by companies, as a factor in increasing the cost and time of development but the majority have yet to be convinced that early strategies for risk management enable clinical development plans to be improved.
Asked to identify the critical factors for achieving successful registration, companies gave priority to communication, a company’s overall strategy for development and how the regulatory function performed within the company.
The three key critical success factors identified by agencies were:
- communication with companies and the level of such interaction
- companies’ strategy and ethos in approaching development programmes
- the robustness and quality of the data submitted.