EU and US agencies bolster bonds

By Anna Lewcock

- Last updated on GMT

Related tags: European commission, European union, Us

European and US regulatory bodies have revamped their relationship
to ease administrative burdens and improve communication, as well
as implementing new measures directed specifically at paediatric
drug products.

Following a meeting earlier this month, the European Medicines Agency (EMEA), the European Commission (EC) and the US Food and Drug Administration (FDA) have agreed to expand their current cooperative activities, strengthening existing frameworks and implementing new strategies to ensure smooth interactions between both sides of the Atlantic. Although the most significant measures to come out of the meeting concerned regulation of paediatric drugs, the agencies also clarified how future interaction between regulatory agencies should be documented and carried out. Particular attention was paid to updating the existing framework surrounding ad-hoc exchanges between the bodies, outlining specific time-frames and a classification system through communication between agencies will be conducted. The aim is establish a more coherent and effective method of exchanging information by which all parties concerned will know what degree of urgency and what level of information is required. In addition to this, a regular, quarterly update on applications to both bodies has been initiated, improving on the ad-hoc lines of communication that were in place previously. Educational workshops and exchanges between the European and US agencies will continue, to further foster links and an understanding of the processes and methods used by the corresponding authorities. "The idea is to learn how the other side does things, and to know what to expect from them,"​ a spokesperson for the EMEA told in-PharmaTechnologist.com. However, the biggest change to come out of this month's meeting was the implementation of a "Principles of Interactions" document that details requirements on regulatory cooperation and transparency between the US Government and the European Commission regarding paediatric therapeutics. Although the US has had legislation in place regarding medicines aimed at the paediatric population for some years, such legislation was only introduced in Europe at the beginning of this year, and only came into full force today. Now that a legislative basis exists in Europe to regulate and approve investigational plans for paediatric drugs, the US and European bodies have decided to "take a further step in agreeing on principles for interactions in relation to paediatric matters".​ The objective is to facilitate a regular exchange of scientific, ethical and other information on paediatric development programmes in Europe and the US to avoid exposing children to unnecessary trials, and to eventually aim for global paediatric development plans that will be compatible for both agencies. Although differences in legal/regulatory requirements may prevent applications for paediatric development plans to each body being absolutely identical, the framework to be introduced aims to simplify administrative activities associated with applications. The guidelines themselves cover aspects of information exchange on product specific paediatric development, ad-hoc exchanges and safety issues, as well as regular communication and updates on relevant information and access to agency databases. Building on successful cooperative efforts in the past on vaccines, oncology and pharmacogenomics, the regulatory authorities on both sides of the pond hope that further transatlantic collaboration will help reduce unnecessary regulatory differences and associated costs to industry and consumers, as well as fostering an improved appreciation of the regulatory systems in action.

Related topics: Clinical Development, Regulatory affairs

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