Brexit comes at a time of major change in clinical trial legislation in the European Union. The EU Clinical Trials Directive 2001\/20\/EC is to be replaced by Regulation (EU) No. 536\/2014.<\/p>\n
Some countries have already prepared domestic implementation of the new EU Regulation (in Spain, for example, Royal Decree 1090\/2015 came into force in January 2016). In the UK, clinical trials are still conducted under The Medicines for Human Use (Clinical Trials) Regulations 2004, which is the UK transposition of the old EU Clinical Trials Directive.<\/p>\n
The UK may decide to simply apply the new EU Regulation when it comes into force, because national legislative implementation isn\u2019t required in the case of regulations. The UK will still have to add Part II (review of national regulatory compliance). So naturally, medical translators will need to be conversant with the new EU Regulation.<\/p>\n
Legally, the UK will need to transpose the EU clinical trial Regulation into English, Scottish, Welsh and Northern Irish laws or incorporate its own new legislation.<\/p>\n
At a practical level, the EMA (European Medicines Agency) will have to move its headquarters out of London and relocate elsewhere.<\/p>\n
The UK will need to reach separate agreements with pharma companies to conduct clinical trials, leading to increased paperwork and translation workload. For example, the single application dossier will no longer cover the UK and the single reporting member state for Part I of the submission review process will not be valid for the UK.<\/p>\n
Manufacturing, storage and distribution of investigational medicinal products (IMPs) will be affected because a Qualified Person based in the UK will no longer be able to authorise batch release. This will involve additional paperwork and translations related to importing and exporting IMPs.<\/p>\n
With regard to medicinal product marketing authorisations, the UK will no longer benefit from the EMA centralised authorisation procedure. New medicinal products will have to be authorised separately under a national procedure by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), mirroring the Swiss drug approval procedure. Again, more work lined up for medical translators!<\/p>\n","protected":false},"excerpt":{"rendered":"
Brexit comes at a time of major change in clinical trial legislation in the European Union. The EU Clinical Trials Directive 2001\/20\/EC is to be replaced by Regulation (EU) No. 536\/2014.<\/p>\n","protected":false},"author":13,"featured_media":11900,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-11899","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-translations"],"acf":[],"yoast_head":"\n