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Major regulatory changes in pharmaceutical laws and regulations in Spain for 2023

The Annual Regulatory Plan for 2023 recently released by the Spanish Government provides for important regulatory changes and developments in the area of medicinal products, including pricing and reimbursement or health...more

Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to...more

New medical device regulation in Spain opened for public consultation

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

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