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news.UK health minister Lord Warner has announced a new program of work to reduce the amount of administration involved in the regulation of over-the-counter medicines. It is hoped that the initiative will both reduce the burden on industry and allow regulators to focus on medicine safety.
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The rules governing minor changes to labeling and patient information leaflets can cost individual companies thousands of pounds and these costs are often passed on to the consumer through pricing of over-the-counter (OTC) medicines.
Through the Better Regulation of Over the Counter Medicines Initiative (BROMI), measures have already been put in place to allow simple changes to medicines labels and patient information leaflets without time-consuming administrative assessment. These measures could allow OTC medicines to be maintained at competitive prices and enable industry to invest some savings in continued innovation.
“OTC medicines are crucial to patient care,” Lord Warner said. “Simpler regulation can improve public health. It enables regulators to focus their time on medicine safety rather than carrying out lengthy administrative processes. BROMI is one example of a key simplification measure the department is taking forward as part of a program to reduce administrative burdens.”
Building on this work, other areas seen to be ripe for simplification, including certain manufacturing changes, are in line for attention. Each of these changes will include appropriate safeguards making sure public safety is not compromised, the UK government has assured.
As well as the new scheme for labeling and patient information leaflets, statutory warnings will be reviewed with the aim of replacing them with information that is clear and in plain English. A code of practice for pack design is currently in development.