top of page
Mancha-1.png
REGISTRY-PSU.png

Health

Cosmetics

Nutritional Supplements

Medical Divices

Generics

New Molecule

Vitamin Drugs

Biologic /

Bio-technological

Mancha.png
Foco-verde.png

NEW MOLECULE

Definition: A new molecule is a substance of natural or synthetic origin which is the active ingredient of a drug not previously used in the country and which efficiency, safety and therapeutic purposes have not been completely documented in the scientific bibliography.

newmolecule-psu.png

What can be considered a new molecule?

a) Drug not having a worldwide register and which is pretended to be registered in Mexico.

b) Drug that, although existing in other countries with limited clinical experience or controversial information, is not registered in Mexico.

c) Drug pretending a combination of two or more drugs not existing in the country.

d) Drug that wants to be registered with another therapeutic indication.

e) Some medical devices

Requirements:

ADMINISTRATIVE / LEGAL /REGULATORY

  •  Cofepris rights

  • Manufacturing license

  • Labeling and leaflet

  • Good manufacturing practices or equivalent of finished product

  • Good manufacturing practices or equivalent of API

  • Free Sales Certificate of equivalent

  • Letter of authorization/representation

  • Patent information

  • Clinical study reports develop in Mexico

  • Pharmacovigilance unit

  • Conclusions of the meeting with the New Molecule Committee

QUALITY INFORMATION

  • APi, excipients and finish formulation methods, validation and stabilities

  • Closure container system

  • Analytical certificates

  • Pharmaceutical development

  • Qualitative / Quantitative formula

FOR THE MANUFACTURER:

  • Cover sheet of production orders

  •  Cover sheet of conditioning orders

  • Validation protocol

  • Process controls

  • Specifications

CLINICAL INFORMATION / PRE-CLINICAL INFORMATION

  • Pharmacodynamics, pharmacokinetics, studies and toxicology

  • Phase l, ll, lll , lV studies (Conclusions of the study)

Pills5.png
Pills-Fondo.png
Mancha.png
Foco-verde.png
bottom of page