Regulatory performance: Critical success factors in today’s environment
15-16th September 2003, Washington DC, USA
Participants at the CMR International Institute Workshop on Regulatory Performance found them in the unique position of receiving first hand reports, from FDA and EMEA, of the confidentiality agreement that was finalised between the two parties on Friday 12 September 2003. The agreement, which will facilitate the sharing of regulatory information on pre- and post-authorisation issues, underlined one of the main themes that ran throughout the Workshop.
There was consensus that one of the most important success factors for regulatory performance is good communications and the exchange of information between experts in companies and agencies, where such exchanges can streamline the product registration process and make new medicines available to patients more efficiently. The Workshop therefore welcomed the new FDA/EMEA agreement and called for cooperation from all sides to expedite its implementation.
A related theme that emerged from the Workshop was the need for a radical re-examination of the limits and constraints of confidentiality placed on regulatory agencies. Whilst commercially valuable information and intellectual property must be fully protected, there are many instances where the authorities have information on general scientific issues that, if shared, could help company researchers to avoid pitfalls, dead ends and, more importantly, potential safety hazards. The Workshop asked that the CMR International Institute’s Advisory Board should examine a proposal that industry should take the initiative in agreeing that agencies could pool and share specified information that could be of benefit in improving the efficiency of research and avoid wasting resources.
These issues were discussed against a background of data on the ever-increasing investment in new drug research whilst the output of new medicines has declined dramatically in recent years. Although the research pipeline appears to remain full, products are staying for longer in the early phases of development where the attrition rate is high. Whilst it was acknowledged that it is far more economical to abort a project at an early stage than later, there were concerns that valuable products could be lost as a result of increasing the regulatory and research hurdles in Phases I and II.
An examination of the extent to which the regulatory environment had changed was one of the objectives of the meeting and, in accordance with the working practices of the Institute, a survey had been carried out among regulators and industry, in advance of the Workshop. Among the many conclusions and inferences that could be drawn from the data was the perception that regulators had become more risk averse in recent years.
Another issue of concern, at the other end of the research cycle, was increasing commitments to conduct post-authorisation studies, which are reported to consume up to 20% of clinical research expenditure. One of the recommendations from the Workshop suggested that the CMR International Institute should carry out a study to quantify the impact of conditions and commitments attached to authorisations.