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MHRA has recently published a guidance on the regulation of medicines …

 

MHRA has recently published a guidance on the regulation of medicines, medical devices and clinical trials if there’s not Brexit deal.

Updated 4thJanuary 2019

 

The UK will continue to recognise existing approvals – both for regulatory and ethics approvals – and there will be no need to re-apply.

If there’s no deal, the UK’s current participation in the European regulatory network for clinical trials would end, and the MHRA would take on the responsibilities for the UK that are currently undertaken through the EU system. This link provides further detail on how we propose the UK system would operate.

 

https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal#medical-devices

42 new active substances have been authorized in the EU in 2018

EMA has published an overview of its key recommendations of 2018 on the authorization and safety monitoring of medicines for human use.

In 2018, EMA recommended 84 medicines for marketing authorization. Of these, 42 had a new active substance which has never been authorized in the EU before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advance therapies.

An overview of some of the most notable recommendations included in the document.

https://www.ema.europa.eu/documents/report/human-medicines-highlights-2018_en.pdf

Patient access to medicines for rare diseases varies largely across Europe

Patient access to medicines for rare diseases varies largely across Europe.

The number of authorized orphan and non-orphan medicines for rare diseases has increased in Europe, but patients in Germany, Scandinavian countries, Switzerland, France and the United Kingdom can access larger numbers of medicines in shorter time.

Patient access to rare disease medicines is affected by high costs, weak efficacy/safety evidence, and social value. European health care systems must determine whether paying for expensive treatment for only a few patients is sustainable.

https://reader.elsevier.com/reader/sd/pii/S109830151830189X?token=75D8D1514C3D86A0E6E2BA37566F8FF698269F62F3F1494853A05BB9A4266A90B87053D37B0F148646E5C17E6CB5255F

United Kingdom’s withdrawal from the European Union (‘Brexit’)

One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.

EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019.

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Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3

From 18/08/2018 the draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3 is available for consultation until 17/02/2019.

As described by EMA, it should be read in conjunction with other EMA and ICH guidelines.

The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support of a monotherapy claim on a case-by-case basis, the inclusion of new sections on neonates and status epilepticus and other changes related to paediatric developments. This guideline provides assistance for the development and evaluation of medicinal products for the treatment of epilepsy in adults and children. The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes.

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