Chile Approves New Technical Standard for the Sanitary Registration of Hemoderivative Pharmaceuticals

The Ministry of Health of Chile has officially approved the "Norma Técnica para el Registro Sanitario de Productos Farmacéuticos Hemoderivados" (Technical Standard No. 240), a new regulation aimed at ensuring the quality, safety, and efficacy of hemoderivative pharmaceuticals in the country. The decree was published in the Diario Oficial de la República de Chile and will come into effect seven months after its publication.

The standard, developed by the National Agency for Medicines (ISP) and the Department of Pharmaceutical Policies and Regulations, was created to address regulatory gaps in the oversight of raw materials used in hemoderivative products. These medications, derived from human blood or plasma, require strict quality control due to their biological nature and critical role in treating various medical conditions.

The Ministry of Health emphasized that the new regulation aligns with international commitments, including those established by the World Trade Organization (WTO). Following a 60-day public consultation period, no objections were raised at the national or international level, allowing for its swift approval.

The Norma Técnica N° 240 will serve as a complementary framework to existing pharmaceutical regulations in Chile, reinforcing sanitary oversight and regulatory standards for hemoderivative medicines. The full text of the regulation will be made available on the Ministry of Health’s official website. 

This development marks a significant step in Chile's ongoing efforts to strengthen pharmaceutical regulations and enhance patient safety by ensuring that all registered hemoderivative products meet the highest scientific and regulatory standards.