Regulation of the pharmaceutical industry in Saudi Arabia

Saudi Arabia (the “Kingdom”) is seeking to become a leader in the field of pharmaceuticals and biotechnology, including through the modernization of regulation, creation of favourable conditions for investors, and active development of scientific and technological infrastructure.

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The main act regulating the pharmaceutical industry in the Kingdom is the Law of Pharmaceutical and Herbal Establishments and Preparations (the “Law”), issued in accordance with Royal Decree No. M/108 of April 15, 2020.

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This alert reflects the current regulation of the pharmaceutical industry and provides an overview of the current legal and investment climate in the Kingdom's pharmaceutical industry.