On March 20, EMA held a seminar in London with the participation of 160 important public opinion
leaders.
The theme of the seminar was "Workshop with many stakeholders of EMA / EC for further
improvement of the implementation of the pediatric regulation". The seminar was divided into five
topics:
Topic 1: Detection of pediatric medical needs – methodology
Topic 2: International cooperation of regulators of pediatric medicines
Topic 3: Timely completion of pediatric investigation plans (PIP)
Topic 4: Improved PIP software
Topic 5: Transparency measures
The pharmaceutical industry is in no hurry to spend a lot of money on research in the field of rare
childhood diseases. It`s hard to find and engage patients because carers often do not want their
children involved in research. As soon as the drugs are approved for adults, doctors appoint them to
children, which makes conducting any research even more complicated.
The EU is aware of these difficulties, and in 2006 it adopted a resolution aimed at resolving or at
least improving the problem. The regulation establishes a system of obligations, rewards and
incentives, and introduces measures to ensure the regular study of medicines, development and
compliance with pediatric therapeutic needs. The idea is based on the simple belief that the
company will have to check every product it develops for potential fitness for children, thereby
gradually increasing the number of products with pediatric indication.
The adopted regulation undoubtedly has a great influence, since the number of pediatric medicines
in recent years has increased significantly. The workshop was the source of a ten-year assessment,
whose results will be posted in the report and a summary that will be published in May. The action
plan will be implemented in mid-2018, and then another progress report will be made. It is expected
that the end result will be a much larger number of approved pediatric PH medications.
P.S: information is gathered from the report of one of the 8 seminar speakers, a delegate to PHA
Europe, the president of the Norwegian Association, Hall Skara