Download Mexico Regulatory Process Flowchart - October 2013

Mexico Regulatory Drug Approval and Funding/Reimbursement Processes
Regulatory and funding approval timelines unknown
Applicant submission of
safety and efficacy
information
Secretaría de Salud (SSA)
evaluation and marketing
authorisation granted
Approved for
access to public
market?
NO
Drug sold through
private market
YES
Applicant submits dossier to
Consejo de Salubridad
General (CSG)
CSG Evaluation and Review
Formal statement and
votes
Expert Committee with all
public institutions
CSG adds drug National
formulary list
CSG issues CB
Code
Applicant submits to each
public institution formulary
Applicant Activity
Secretaría de Salud (SSA) Activity
Consejo de Salubridad General (CSG) Activity
Expert Committee Activity
Source: International Society for Pharmacoeconomics and Outcomes Research, 2011
http://www.ispor.org/HTARoadMaps/MexicoMD.asp
October 1, 2013
Funded through
public market