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The European Commission releases revised draft guidance on Clinical Trials Regulation EU 5362014.

European Union - January 6 2020 In November 2019, the European Commission released a revised version of the Q&A document on the Clinical Trials Regulation EU 5362014. The main...

Montserrat Llopart.

The Spanish Council of Ministers approve amendment

Spain - January 6 2020 Last December 5, 2019, the Spanish Council of Ministers approved Royal Decree number 7172019 by means of which it amends Royal Decree number...

Montserrat Llopart.

The European Commission issues aide-memoire for Good Distribution Practice (GDP) inspections in relation to Safety Measures Regulation EU 2016161.

European Union - January 6 2020 On October 18, 2019, the European Commission issued an aide-memoire in relation to good distribution practice (GDP) inspections of medicines. The...

Montserrat Llopart.