Submitting Clinical Trials through DIGIPRiS in México

ABSTRACT

Clinical trials are essential for developing new medical treatments and advancing scientific knowledge. In México, DIGIPRiS system has recently revolutionized the clinical trial submission process, making it more efficient and transparent. Managed by COFEPRIS, this digital platform allows Contract Research Organizations (CROs) and sponsors to submit the required documentation electronically. Key requirements include the trial protocol, ethics committee approval, safety and pharmacovigilance plans, and participant informed consent. DIGIPRiS streamlines the management of these studies, providing a structured and accessible channel that complies with national and international regulations, speeding up patient access to new therapies.

RESUMEN

Los ensayos clínicos son esenciales para el desarrollo de nuevos tratamientos médicos y el avance del conocimiento científico. En México, el sistema DIGIPRiS ha revolucionado el proceso de presentación de ensayos clínicos, haciendo que sea más eficiente y transparente. Este sistema digital, gestionado por COFEPRIS, permite a las organizaciones de investigación contratada (CROs) y patrocinadores enviar la documentación requerida de manera electrónica. Entre los requisitos clave se encuentran el protocolo del ensayo, la aprobación de un comité de ética, planes de seguridad y farmacovigilancia, y el consentimiento informado de los participantes. DIGIPRiS facilita la gestión de estos estudios al proporcionar un canal estructurado y accesible que cumple con normativas nacionales e internacionales, acelerando el acceso de los pacientes a nuevas terapias.

Benefits of Using DIGIPRiS for Clinical Trial Submissions in Mexico

1. Efficiency and Speed: DIGIPRiS allows sponsors and Contract Research Organizations (CROs) to submit all documentation electronically, eliminating the need for physical paperwork. This speeds up the review and approval process by COFEPRIS, reducing waiting times. (List of CROs registered in Mexico).
2. Transparency: The system provides real-time tracking of application statuses, offering greater visibility into the progress of clinical trials and approval stages. This improves planning and coordination.
3. Regulatory Compliance: DIGIPRiS ensures that all studies comply with national and international regulations, including ethical, safety, and pharmacovigilance requirements, minimizing the risk of errors in document submission.
4. Centralized Access: Through a unified digital platform, users can upload, store, and manage all clinical trial information in one place. This reduces the likelihood of document loss and simplifies the updating and management of study data.
5. Cost Reduction: By eliminating the need for physical document submissions and shortening review times, companies can save costs on submission logistics and accelerate the start of their clinical trials.
6. Ease of Interaction with COFEPRIS: DIGIPRiS enables direct and structured communication with COFEPRIS, making it easier to correct errors or submit additional information without the need for in-person procedures.
7. Fostering Innovation: By streamlining the approval process, DIGIPRiS helps new treatments and technologies reach the market faster, benefiting patients and contributing to the development of clinical research in Mexico.

These benefits make DIGIPRiS a fundamental tool for those looking to submit clinical trials efficiently and securely in Mexico.

México ocupa el segundo lugar en Latam en estudios Clínicos para investigar efectos de nuevas terapias

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Submission Format

All documentation must be submitted in printed form and preferably in electronic format. The documents should be organized in the following order:

1.- Authorization Format: Complete the necessary forms for authorizations as specified by COFEPRIS.

COFEPRIS "Homoclave 04-010", modalities A, C y D.

2.- Payment Receipt: Provide the original and two copies of the payment receipt for rights, as mandated by the Federal Law of Rights.

3.- Initial Protocol:

3.1 Favorable Opinion: Include the favorable opinion from the relevant research, ethics, and, if applicable, biosecurity committees, which your Reffering and hired CRO company will help you provide

3.2 Risk Analysis: Conduct a comparative analysis of the risks involved in the proposed study versus established diagnostic and treatment methods, along with the expected living conditions of the subject with and without the proposed intervention.

3.3 Informed Consent: Attach the informed consent document from the research participant or their legal representative. Provides clear and detailed information about the purpose of the study, procedures, potential risks, benefits and alternative treatments.

4. Summary of Preclinical and Clinical Information:

4.1 Authorization Letter: Obtain and submit a letter of authorization from the head of the unit or institution where the research will be conducted.

4.2 Description of Available Resources:

4.3 Confidentiality Letter: Submit a confidentiality letter concerning the reporting of adverse events by the principal investigator.

4.4 Principal Investigator's Professional History: Include the principal investigator’s academic background, representative scientific production, clinical practice, and copies of the legally issued documentation from relevant educational authorities.

4.5 Staff Preparation: Provide information about the training and experience of the medical, paramedical, and other experts involved in the research activities.

4.6 Study Timeline: Include a detailed schedule outlining the stages and duration of the study.

4.7 Import Supply Quantity: Provide details on the quantity of imported supplies required for each phase of the study. This information will be acknowledged but not authorized by COFEPRIS.

4.8 Other Requirements: Address any additional requirements set forth by the current health regulations concerning research involving human subjects.

Importance of Adhering to Requirements

These documentation requirements are crucial for obtaining approval for research protocols in the fields of pharmaceuticals, biologics, and biotechnology. They not only ensure compliance with regulatory standards but also enhance the integrity and ethical considerations of the research conducted.

By preparing thorough and accurate documentation, researchers can significantly reduce the risk of delays or rejections in the authorization process. It is essential to ensure that all materials are complete and aligned with current regulations to facilitate the authorization process.

Submission Process

The documentation should be submitted to COFEPRIS through their official digital platform, DIGIPRIS, which streamlines the application and review process for clinical research protocols. This approach not only helps maintain high standards in research ethics and safety but also encourages innovation in medical treatments and therapies.

Guide for Submitting Research Protocols

Objective: Establish the minimum requirements for the “Request for Authorization of Human Research Protocols” to standardize submission criteria.

Scope: Applicable to all human research requiring authorization.

1.-Required Documentation:

Guideline (CONAMER): Request for Authorization of Research Protocol on Human Beings.

• Application form.
• Detailed research protocol.
• Informed consent.

2.- Evaluation Criteria:

• Scientific relevance.
• Safety and well-being of participants.
• Compliance with ethical and legal standards.

3.- Review Process:

• Initial evaluation by the ethics committee.
• Technical and scientific review.
• Final approval and issuance of authorization.

4.- Ethical Considerations:*

• Protection of participants’ rights.
• Transparency and confidentiality of data.

This guide ensures that research protocols meet necessary standards to protect participants and guarantee the scientific validity of studies. You can review the full document here.

Conclusion:

Benefits of Using DIGIPRiS for Clinical Trial Submissions in Mexico

In summary, DIGIPRiS offers a transformative approach to clinical trial submissions in Mexico by enhancing efficiency, transparency, and regulatory compliance. The electronic submission process significantly reduces waiting times and simplifies the management of clinical trial information, fostering a more organized and streamlined workflow. By centralizing access to data and facilitating direct communication with COFEPRIS, DIGIPRiS minimizes the risk of errors and promotes a quicker response to regulatory requirements. Additionally, the platform helps reduce costs associated with physical document submissions, enabling sponsors and CROs to allocate resources more effectively. Ultimately, by accelerating the approval process for new treatments and technologies, DIGIPRiS plays a crucial role in advancing clinical research in Mexico, ensuring that patients gain timely access to innovative therapies.

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References

1. COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)

• Regulations and Guidelines for Clinical Trials: COFEPRIS provides guidelines and requirements for conducting clinical trials in Mexico. These documents detail the regulatory framework, including ethical considerations and procedural requirements for researchers.
• Link: COFEPRIS Clinical Trials

2. NOM-012-SSA3-2012

• Ethical Principles for Biomedical Research Involving Human Subjects: This official Mexican regulation establishes ethical guidelines for conducting biomedical research with human subjects, emphasizing informed consent, participant safety, and the oversight of ethics committees.
• Link: NOM-012-SSA3-2012

3. NOM-177-SSA1-2013

• Requirements for Demonstrating the Bioequivalence of Pharmaceutical Products: This regulation outlines the criteria and protocols for conducting bioequivalence studies, which are essential for the approval of generic and similar medications in Mexico.
• Link: NOM-177-SSA1-2013

4. Mexican Pharmaceutical Industry Association (AMIF)

• Guidelines and Resources: AMIF provides resources and guidelines for pharmaceutical research, including clinical trials, emphasizing compliance with regulations and ethical standards in the industry.
• Link: AMIF

5. DIGIPRIS. Investigación y Ensayos clínicos

• Link: DIGIPRIS: ENSAYOS CLINICOS

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