TOPRA Calls for More Practical Approach to Regulatory Development

May 18, 2005

Applied Clinical Trials

TOPRA has called on the regulatory community to develop a more consultative approach to legislation in light of a new poll revealing widespread concerns with the current channels of feedback.

TOPRA has called on the regulatory community to develop a more consultative approach to legislation in light of a new poll revealing widespread concerns with the current channels of feedback.

The new poll, which involved nearly 10% of TOPRA's membership, was published today to the TOPRA community. It highlights a series of worries within the current process of regulatory development.

When asked whether the practical implications of new legislation are sufficiently taken account of in the development phase, over 90 % of respondents believed that more could be done. This supports the motives behind TOPRA's continuing strategy of working closely with regulatory stakeholders to ensure regulation is effectively communicated

Over three quarters of respondents also felt that there is not an adequate system of feedback from the industry to those who draft the regulation - a problem that the Commission has spent the last six working hard to rectify.

Lynda Wight, TOPRA General Manager said:

"I think this confirms the view that there is still a lot of work for us to do to ensure that the views of those working at ground level are communicated to the regulatory agencies and policy-makers. Dr Philippe Brunet, formerly of the Commission, highlighted 'the communication channel between legislators and the grass-roots RA community' as a key area of development when he spoke at the TOPRA launch in April last year.

"We now need to work closely with our partners at the Commission and the regulatory agencies to ensure that we can consistently meet the expectations of the regulatory community."

TOPRA -- The Organisation for Professionals in Regulatory Affairs was launched on January 5th 2004. It is an international organisation with over 3,000 members across 52 countries.

TOPRA aims to provide its international membership with the highest quality education, information and career development services to ensure that the value and strategic contribution of regulatory affairs is universally recognised.

TOPRA conducted a popular poll of its membership in April 2005 asking a series of questions regarding the current state of the regulatory process.

Over 200 members responded to the poll.

91.7% of respondents said that they do not think the practical implications of new legislation are sufficiently taken account of when legislation is being drafted.

75.2% of respondents do not think there is an adequate system of feedback from industry to those who draft the legislation after implementation.

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