Towards a new regulation of observational studies with medicines in Spain

The future Royal Decree will be applicable to all observational studies with medicinal products for human use defined in Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, Research Ethics Committees with medications and the Spanish Registry of Clinical Studies, and that are carried out in Spain. As new features to be …

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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 …

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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 …

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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 …

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