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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 highlighted is the use of a nomenclature closer to the reality of the field of research whose examples are:

  • definitions of the beginning or end of the study, pseudonymization, substantial modification of the protocol, protocol;
  • the application of the definitions provided for in article 2 of Royal Decree 1090/2015 – among which are the definition of adverse reaction, usual clinical practice, promoter, principal investigator or informed consent – and
  • definitions regarding the Post-authorization security studies and the risk management plan included in Royal Decree 577/2013 regulating the pharmacovigilance of medicines for human use.



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.

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.

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.

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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