The Ministers’ Council approved last 6th December a Royal Decree requiring clinical trials to prove the effectiveness of homeopathic products with therapeutic indication. The goal is to harmonize the required processes for the approval and marketing of drugs with therapeutic indications.
To date, the need to conduct clinical trials demonstrating the safety and efficacy of drugs did not affect homeopathic drugs. This new Royal Decree is another step in the battle started by the Ministry of Health and the Ministry of Science in 2018 against so-called “pseudotherapies”, including homeopathic drugs.
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