Suggestions that might be considered for improving the review process

Summary

• 1. Several suggestions for overcoming the problems experienced by industry or regulators in achieving an efficient regulatory review were made by the workshop participants. The overriding theme was increased partnership between the regulators and the pharmaceutical industry, and there was agreement that five general areas require further discussion: the size of the dossier, dialogue, the review process itself, company strategies and specialised procedures such as mutual recognition or interactive submissions.

• 2. The participants agreed that one aim should be to reduce substantially the size of the dossier, particularly the clinical section. This will require collaboration between industry and regulators, and will be assisted by the ongoing ICH discussions.

• 3. Authorities can learn from each other and industry in order to re-engineer the review process, and there is an onus on industry to improve the quality of their submissions and respond to questions in an efficient and timely manner. The participants agreed that a long-term goal should be to move to a transnational system that consists of a single submission and a prompt, uniform decision.

Throughout the workshop, the presentations and discussion focused on problems experienced by industry or regulators in achieving an efficient regulatory review. Many suggestions for overcoming these problems were made by the participants, which were discussed in some detail in syndicate groups. The overriding theme was increased partnership between the regulators and the pharmaceutical industry, who should be working closely together while recognising that each has different roles and responsibilities.

In the time available it was not possible to produce a mutually agreed list of specific actions which could be taken by either industry or regulators to improve the review process. However, there was agreement that five general areas require further discussion: the size of the dossier, dialogue, the review process itself, company strategies and specialised procedures such as mutual recognition or interactive submissions (Tables 14.1–3).