12. Resources

1. Mexican Regulatory Agency - https://www.gob.mx/cofepris 

2. Language Requirements - https://clinregs.niaid.nih.gov/country/mexico 

3. Regulatory and Ethics Approval Requirements - https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/HlthResRegs-GoogleTranslation.pdf 

4. Import & Export Requirements

1. https://www.gob.mx/cms/uploads/attachment/file/652233/COFEPRIS-01-024.pdf
2. https://clinregs.niaid.nih.gov/country/mexico#specimen_import_&_export 

5. In Country Requirements - https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/HlthResRegs-GoogleTranslation.pdf 

6. Local Registries

1. https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/G-RNECManual_v1_Spanish.pdf 
2. https://siipris03.cofepris.gob.mx/RegNacEnsClinicos/

7. Clinical Study Documents

1. https://dof.gob.mx/nota_detalle.php?codigo=5424575&fecha=05/02/2016 
2. http://academy.gmp-compliance.org/guidemgr/files/E6_R1_GUIDELINE.PDF 
3. https://clinregs.niaid.nih.gov/country/mexico#product_management 

8. Adverse Events Reporting 

1. https://dof.gob.mx/nota_detalle_popup.php?codigo=5490830
2. https://dof.gob.mx/nota_detalle.php?codigo=5490830&fecha=19/07/2017#gsc.tab=0
3. https://clinregs.niaid.nih.gov/country/mexico#safety_reporting 

9. Insurance Requirements

1. https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/G-ApplicReqs-GoogleTranslation.pdf 
2. https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/MX-GCP-COFEPRIS-GoogleTranslation.pdf 

10. Ethics Committee Documentation Requirements - https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/MX-GCP-COFEPRIS-GoogleTranslation.pdf 

11. Timings

1. https://www.gob.mx/cms/uploads/attachment/file/420833/Gui_a_CEI_2018.pdf
2. https://dof.gob.mx/nota_detalle.php?codigo=5276107&fecha=31/10/2012 

12. Guidance on Electronic Submissions

1. https://www.gob.mx/cms/uploads/attachment/file/652277/COFEPRIS-04-010-A.pdf
2. https://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013#gsc.tab=0
3. https://www.gob.mx/cms/uploads/attachment/file/369736/Requisitos_para_presentar_la_informaci_n.pdf 

13. Informed Consent - https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/G-RECs-Op-2018-GoogleTranslation.pdf 

14. Periodic Study Reporting -  https://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013#gsc.tab=0 

15. Agency Notification - https://www.gob.mx/cms/uploads/attachment/file/149032/Gu_a_de_Sometimiento_COFEPRIS-04-010-A.pdf  

16. Data protection -http://biblioteca.udgvirtual.udg.mx/jspui/bitstream/123456789/1210/1/Reglamento%20de%20la%20ley%20federal%20de%20protecci%c3%b3n%20de%20datos%20personales%20en%20posesi%c3%b3n%20de%20los%20particulares.pdf

17. Labeling - https://www.dof.gob.mx/nota_detalle.php?codigo=5424377&fecha=04/02/2016

18. Biological Specimens

1. https://www.gob.mx/cms/uploads/attachment/file/652233/COFEPRIS-01-024.pdf
2. https://www.gob.mx/tramites/ficha/permiso-de-salida-de-territorio-nacional-de-celulas-y-tejidos-incluyendo-sangre-sus-componentes-y-derivados-asi-como-otros-productos-de-seres-humanos/COFEPRIS225

19. Vulnerable Subjects

1. https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/HlthResRegs-GoogleTranslation.pdf
2. https://clinregs.niaid.nih.gov/country/mexico#pregnant_women,_fetuses_&_neonates
3. https://clinregs.niaid.nih.gov/country/mexico#mentally_impaired