How are new medicines approved in Europe?

Medicines pills tablets
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If you have MS or any other chronic or acute illness, you might be dependent on pharmaceutical intervention at some stage.

But, how exactly do your medicines arrive in your hands once they passed the clinical trials stage?

The EMA (European Medicines Agency) own scientific committees will scientifically assess the clinical trial data. Once this stage is finished, the EMA gives independent recommendations on medicines. When they receive a green light, i.e. when the benefit of the medicine is greater than its risk, the EMA gives its approval to the EC, the European Commission. This means it can be authorised and can now be marketed across the European Union, including the EEC, the European Economic Area.

It doesn’t end there, however. The EMA will continue to monitor the safety of the medicine when it’s on the market.

More info:

⬛ Authorisation of medicines

⬛ Committees, working parties and other groups

⬛ Committee for Medicinal Products for Human Use (CHMP)

⬛ Committee for Orphan Medicinal Products (COMP)

⬛ Committee on Herbal Medicinal Products (HMPC)

⬛ Committee for Advanced Therapies (CAT)

⬛ EU institutions and bodies in brief

More on medicines on IMSM:

⬛ MS Treatments (2018)

⬛ Disease Modifying Therapies for Multiple Sclerosis: A Review of the Perspectives of Irish People with MS

⬛ Understanding clinical trials

While you’re here, why not check out these pages?

UPDATED: August 17th, 2018

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© Willeke Van Eeckhoutte and Ireland, Multiple Sclerosis & Me, 2018

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Quirky, tenacious and neurologically compromised female expat living in Ireland since 2002 ◾ IRELAND BLOG AWARDS WINNER - BEST BLOG POST 2018 with '3443 Needles' ◾ Ireland Blog Awards Finalist 2014, 2015, 2017 ◾ MyTherapyApp Best MS Blog for Simplicity 2018 ◾ Everyday Health Top 10 MS Blog of 2018 ◾ Feedspot Top 50 MS Blog 2017, 2018 ◾ Contributor to the Teva MS blog Life Effects ◾ Contributor to the Novartis MS blog Living Like You ◾ Contributor to MS Ireland’s blog MS & Me ◾ Contributor to The Mighty ◾ Guest contributor to ◾ WEGO Health Patient Leader Award Nominee 2018

One thought on “How are new medicines approved in Europe?

  1. Good morning dear Blue-eyes and thanks for this good article about the approval process of new medicines in the EU. However you should point out that the system is under duress now as the headquarters is located in the UK, which will leave the EU in the near future. They are discussing where to relocate now and I do hope they chose a “serious” place like Barcelona or Prague to continue their exacting and necessary watchdog role. Un baccione. Arrivederci!

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