Biologics Compliance Guide for Mexico
This is a compliance guide for clinics that want to operate in Mexico.
Key Pieces of Legislation:
Federal Commission for Protection against Sanitary Risks (COFEPRIS)
Regulates the ethical use of human tissues, including stem cells.
NOM-257-SSA1-2014
Specifies the health requirements for the disposition of organs, tissues, and cells.
NOM-240-SSA1-2012
Concerns health services for human cells, tissues, and organs.
General Health Law and the Official Mexican Standards (NOMs)
Provides guidelines for the ethical and scientific use of stem cells in research and clinical applications.
Regulation on the Licensing of Medicinal Products for Human Use
Detailed guidelines for the licensing of medicinal products
Compliance Checklist
Compliance with COFEPRIS Regulations:
Ensure adherence to the guidelines and regulations set by the Federal Commission for Protection against Sanitary Risks (COFEPRIS) for stem cell therapies.
Approval from Regulatory Bodies:
Obtain necessary approvals from COFEPRIS for the use of stem cell therapies.
Ethical Approval:
Obtain approval from ethics committees for any stem cell therapy studies involving human subjects.
Informed Consent:
Obtain informed consent from patients, clearly explaining the potential risks, benefits, and alternatives to the treatment.
Proper Handling and Storage:
Follow proper protocols for the handling, storage, and administration of stem cells to maintain their viability and safety.
Documentation and Record-Keeping:
Maintain detailed records of all stem cell treatments, including patient consent forms, treatment protocols, and outcomes.
Patient Safety and Monitoring:
Implement safety measures and monitoring protocols to track patient responses and manage any adverse effects.
Insurance and Liability:
Ensure that the clinic has appropriate insurance coverage for stem cell treatments and is aware of potential liability issues.
Stay Updated on Legal Changes:
Regularly review and stay informed about any changes in federal, state, and local regulations regarding stem cell treatments.
Who can administer
Doctors (General Practitioners and Specialists): Physicians with appropriate licenses who are trained in regenerative medicine and stem cell therapies.
Nurses: Registered nurses who are certified and licensed to assist in the administration of exosome treatments under the supervision of a licensed physician.
Pharmacists: Licensed pharmacists who can dispense exosome products in accordance with regulatory guidelines.
Medical Assistants: Certified medical assistants who work under the supervision of licensed healthcare professionals.
Administration Research
Sanitary License: Establishments must obtain a sanitary license from the Federal Commission for Protection against Sanitary Risks (COFEPRIS).
Responsible Physician: Each establishment must have a responsible physician who oversees the treatments.
Organ, Tissue, and Cell Bank License: If the establishment handles these materials, a specific license is required.
Bioethics Committee: An ethics committee must be established to oversee the ethical aspects of treatments.
Biosafety Committee: A biosafety committee is required to ensure the safe handling and administration of treatments.
Research Committee: If the establishment conducts research, a research committee is necessary.
Transplant Committee: For establishments involved in transplantation, a transplant committee is required.
Source Info
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Our mission is to equip practitioners with essential knowledge on biologics, covering protocols, regulatory guidelines, and foundational insights. This site serves as a trusted resource for navigating the evolving landscape of stem cell applications in clinical practice.
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