A summary of the outcome of a survey carried out by the CMR International Institute for Regulatory Science among pharmaceutical companies.
Although the pharmaceutical industry is moving towards integrated global development of new medicines and simultaneous submission to regulatory authorities, this has yet to be achieved routinely and, for many companies, remains a vision for the future.
The need for additional clinical programmes, coupled with companies’ development and filing strategies have resulted in the so-called ‘Japan gap’ whereby patients in Japan may not have access to new products until two or more years after marketing in the US and Europe.
The majority of companies predicted that, by 2010 they would be filing new drug applications simultaneously in the three ICH regions, but the current situation shows applications first being filed in the US and Europe, with submissions to Japan being much later in the order of filing, after Canada, Australia and other countries. Some 60% of companies reported that they filed applications more than two years after the first submission in the rest of the world.
When asked about clinical development strategies in an ‘ideal’ scenario where clinical endpoints were not an issue, 70% of companies indicated that, in the current environment, they would carry out an integrated development programme in the US and Europe with development in Japan at a later time. For 75% of companies, however, the vision for 2010 was for integrated development with the same clinical protocols in all three regions.
Asked about perceptions of the major barriers to global development the issues that were identified as most serious were differences in medical practice and culture, the cost of patient recruitment, clinical trial infrastructure, regulatory hurdles and patient availability.
Productive communications with regulatory agencies are a key factor in achieving global development strategies. The survey found that the US FDA was the agency most frequently consulted, especially at the pre-clinical stage. For all agencies (US, EMEA, EU Member States and Japan) consultations were most frequently held at end-of-Phase 2 and at the pre-submission stage.
Of concern is the high percentage of companies (87%) that had experienced significantly differing scientific advice from different agencies. The areas highlighted were clinical endpoints, comparator agents and dose levels. It was apparent that industry would welcome discussions on a fundamental paradigm shift to move away from the ‘traditional’ approaches to drug development and review. This might include the integration of risk management plans into drug development in order to reduce Phase III studies, and the establishment of a globally coordinated safety database. The ultimate aim, however, would be to move towards joint reviews and decision-making.