Doctors Hospital Auna Becomes First Private Hospital with Legal Capacity to Produce Radiopharmaceuticals
Monterrey, NL. Doctors Hospital Auna has been awarded the Good Manufacturing Practices (GMP) certificate and health registrations by the Federal Commission for Protection against Health Risks (Cofepris) for the production of radiopharmaceuticals. This achievement positions Doctors Hospital Auna as the first private hospital in Mexico with legal, technical, and regulatory capacity to manufacture these crucial components in nuclear medicine.
Background on Doctors Hospital Auna and its Significance
Doctors Hospital Auna is a prominent healthcare institution located in Monterrey, Mexico. As part of the Auna regional health ecosystem with a presence in Mexico, Peru, and Colombia, it focuses on delivering advanced, human-centered healthcare. The hospital’s recent achievement further solidifies its standing as a reference center for nuclear medicine in Latin America.
Cofepris Certification and its Importance
The Cofepris certification signifies that the hospital’s infrastructure, processes, and personnel meet the highest national and international standards for quality, safety, and efficacy. With its powerful KIUBE 150 cyclotron—the most potent in the country—Doctors Hospital Auna can produce a broader range of radioisotopes, including those with short and high-energy half-lives. These isotopes enable more precise diagnoses and timely, personalized oncological treatments.
Investment and Implementation
Obtaining this certification required significant investment in infrastructure, robust quality management systems, and specialized personnel training. Key components included integrating a Laboratory Information Management System (LIMS), essential for automated process control and radiopharmaceutical traceability.
Distribution and Impact on the Healthcare Ecosystem
Besides supplying its internal operations, Doctors Hospital Auna can distribute these essential components to other PET centers in the region and nationwide. This strengthens Mexico’s diagnostic imaging ecosystem by reducing waiting times, enhancing diagnostic precision, and enabling informed decision-making—especially in oncology.
New Opportunities for Research and Collaboration
The production of radiopharmaceuticals opens new avenues for clinical research, personalized therapy development, and collaboration with institutions like the ININ (National Institute of Nuclear Research) and OIEA (International Atomic Energy Agency).
UNAM’s Role in Radiopharmacy and Micro-PET
Since the 1990s, the Faculty of Medicine at the National Autonomous University of Mexico (UNAM) envisioned a PET-CT unit. The project came to fruition in 2002 when the cyclotron was installed, and various tests were conducted. In January 2002, the first patient studies were performed, making it the first unit of its kind in Mexico and Latin America.
The Radiofarmacy and Micro-PET laboratory was subsequently established, adhering to the standards set by Mexico’s National Commission for Nuclear Safety and Safeguards under the Secretariat of Energy.
UNAM’s Continued Production
UNAM continues to produce radiopharmaceuticals, supplying approximately 60% of the requirements for central Mexico’s states. The university has the largest radiopharmaceutical production in Latin America, with its Radiofarmacia-Ciclotrón unit playing a crucial role in research and production of these compounds for more precise diagnostics.
Lanider’s Contribution to the Radiopharmaceutical Chain
The National Institute of Nuclear Research established the Laboratorio Nacional de Investigación y Desarrollo de Radiofarmacos (Lanider), which is part of Conacyt’s Laboratories Network and associated with the National Cancer Institute.
Lanider conducts research, production, quality control, and distribution of radiopharmaceuticals. It holds the GMP certification from Cofepris and supplies over 100 Centros de Medicina Nuclear (Medical Nuclear Centers) in Mexico. Lanider’s portfolio includes 26 different radiopharmaceuticals, which are exported to Costa Rica, Guatemala, Dominican Republic, South Africa, Saudi Arabia, the United Arab Emirates, and Indonesia.
Key Questions and Answers
- What is the significance of Doctors Hospital Auna receiving Cofepris certification? This certification signifies that Doctors Hospital Auna meets the highest national and international standards for quality, safety, and efficacy in radiopharmaceutical production.
- What advantages does in-house radiopharmaceutical production offer? In-house production reduces waiting times, enhances diagnostic precision, and enables informed decision-making—especially in oncology.
- What new opportunities does radiopharmaceutical production open? It opens avenues for clinical research, personalized therapy development, and collaboration with institutions like ININ and OIEA.
- What role does UNAM play in radiopharmacy and micro-PET? UNAM has been instrumental in establishing PET-CT units and continues to produce radiopharmaceuticals, supplying a significant portion of central Mexico’s needs.
- What is the Lanider’s contribution to the radiopharmaceutical chain? The Lanider conducts research, production, quality control, and distribution of radiopharmaceuticals, supplying over 100 medical nuclear centers in Mexico and exporting to several countries.
