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Elisabet Cots

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On 20 January, 2021, part of Law 18/2020 of 28 December to facilitate economic activity, enters into force, following publication in the Official Gazette of the Government of Catalonia on 31 December. The main aim of this law is to facilitate economic activity in an all-digital environment, allowing for a more agile, efficient relationship between the administration and companies, supposedly with fewer administrative burdens for companies, and a more simplified administrative intervention framework.

Royal Decree-Law 36/2020 of 30 December 2020, establishing urgent measures to modernize the public administration and implement the government’s recovery, transformation and resilience plan (“RDL of Modernization”) was published on the last day of 2020 and entered into force on 1 January 2021.

On 26 November 2020, the Spanish Official State Bulletin published the Royal Decree 957/2020, of 3 November, regulating observational studies with medicinal products for human use, which will come into effect on 2 January 2021. This royal decree intends to ease the administrative procedures applicable to observational studies in light of recently adopted instruments at EU level (with the European Medicines Agency-approved guidance on post-authorization efficacy studies) and Spanish level (with the enactment of Royal Decree 1090/2015 on clinical trials with medicinal products, which introduced the legal concept of observational study). Observational studies are an essential tool to gather personal health data on conditions for use, safety and effectiveness of medicinal products, and to ultimately enhance clinical practice in the interest of patients.