It’s good to talk, says Europe’s ambitious regulator
pharmafile | February 12, 2004 | News story | |Â Â Â
Europe's medicines regulator has unveiled its new long-term strategy to improve its work on human medicines as it prepares to take on greater power within an expanded European Union.
Thomas Lonngren, head of the London-based EMEA, said the strategy would help it become a world-class regulator, with the "highest level of scientific expertise" at its heart.
The initiative has also been prompted by an audit of its key decision-making body of human medicines, the CPMP, conducted last year.
The EMEA wants to make its scientific advice/protocol assistance procedure more efficient by building on improvements it says it has already made. At the heart of the changes is a simple goal to talk more with clinical trial sponsors during the approval process.
Recent EMEA research found that pharmaceutical companies which had requested scientific advice when developing new medicines had a higher success rate and a faster review time when they came to apply for marketing authorisations.
This will form part of a more general drive to improve the openness and transparency of the CPMP which will include a "systematic and proactive" consultation on how to develop its guideline documents for companies.
Another element of this new openness will be greater communication with the public. A summary of the European Public Assessment Report will be written in a consumer-friendly style, and give information on products withdrawn or rejected by the CPMP as well as those that have been launched.
The Agency will implement its ambitious action plan over the next 18 months and expects it to yield results as early as the second half of this year.
Thomas Lonngren, said: "The Agency is confident that the implementation of the actions will enable the EMEA to meet the important challenges which will affect the EU regulatory system over the next few years and, as a result, to position itself successfully in an ever-developing international regulatory environment."
The EMEA is set to take on greater powers when Europe's politicians agree on changes to laws, including making approval through the EMEA mandatory for HIV/AIDS, diabetes, cancer and neuro-degenerative diseases Although most of the legislation will not come into force until autumn 2005, Mr Lonngren is keen to see it fine-tuned well in advance.
The first changes from the legislation could come into effect within the next few months, including a simpler name – the European Medicines Agency (EMA) – and the allocation of one representative on the CPMP per member state, 25 in total post EU enlargement.
Related Articles:
'European FDA' one step closer
Thursday , November 06, 2003
