How are new medicines approved?

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

⬛ Understanding clinical trials

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

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• You retired at age, what?
• Bliss
• The beauty and cruelty of words
• MS societies around the world (2018)
• MS treatments (2018)
• Top posts
• Contact

UPDATED: August 17th, 2018