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Regulatory Harmonisation between US and EU

16 June 2015


It may not come as a surprise that even with the efforts of groups such as the International Conference on Harmonisation (ICH); who work on the harmonisation of regulatory standards between international regulatory bodies; a lack of regulatory consistency remains.

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA), have harmonised pharmaceutical regulatory standards as required by ICH but still may require different data to approve the same medicinal products. For example, a clinical trial design may be acceptable within the EU but have to be modified for the US.

Potential legislation?

A bill named ‘Speeding Access to Already Approved Pharmaceuticals Act of 2015’ was introduced by Tim Ryan (US representative for Ohio’s 13th congressional district) and Steve Stivers (US representative for Ohio’s 15th congressional district). One of the motivations for reintroducing this bill was mentioned by Stivers in a statement he made outlining his opinion that the FDA’s red tape causes delays of up to several years in approval for life-saving and life-changing medical treatments, delays which could result in the unnecessary death and suffering of American patients.

Even though the FDA approves between 66% - 74% of drugs before any other regulatory authority in the world, a few medicinal products are still approved elsewhere first.

The bill, introduced March 2015 in the US House of Representatives, has been proposed to accelerate access of EU approved medicines to American patients. If passed, the legislation would require the FDA to expedite the review and approval of pharmaceutical products/devices already approved in Europe.

The bill, also introduced June 2014, applies to any pharmaceutical, biological medicinal product and medical devices. If approved, the FDA would be required to cut their review process of any drug/medical device already approved in the EU by half. This would mean a review process turn-around time of 90 days as opposed to 6 months. Expedited review would have to be requested by the drug sponsor.

Whilst the bill has good intentions, there are still a few areas which need to be thought about. The bill is not clear on whether it applies to products/devices approved through the European centralised or decentralised procedures. There is also the thought that the 90 day turn around will result in the FDA issuing more rejection letters to applicants on safety grounds if they do not obtain all the relevant data on time.


The pharmaceutical regulatory industry is continually thinking of better, more practical ways in which patients are able to access the healthcare products they require. The above mentioned bill is a perfect example of this and if passed could potentially mean faster access to medicines for American patients, which would be a positive step forward.

Written by Vignon Mansilla, Regulatory Affairs Assistant

Further information

16 June 2015