¡Hola!
¡Hola!
Rubén Bross
Health
Cosmetics
Nutritional Supplements
Medical Divices
Generics
New Molecule
Vitamin Drugs
Biologic /
Bio-technological
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.
What can be considered a new molecule?
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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
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Cofepris rights
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Manufacturing license
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Labeling and leaflet
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Good manufacturing practices or equivalent of finished product
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Good manufacturing practices or equivalent of API
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Free Sales Certificate of equivalent
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Letter of authorization/representation
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Patent information
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Clinical study reports develop in Mexico
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Pharmacovigilance unit
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Conclusions of the meeting with the New Molecule Committee
QUALITY INFORMATION
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APi, excipients and finish formulation methods, validation and stabilities
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Closure container system
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Analytical certificates
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Pharmaceutical development
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​Qualitative / Quantitative formula
FOR THE MANUFACTURER:
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Cover sheet of production orders
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Cover sheet of conditioning orders
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Validation protocol
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Process controls
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​Specifications
CLINICAL INFORMATION / PRE-CLINICAL INFORMATION
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Pharmacodynamics, pharmacokinetics, studies and toxicology
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Phase l, ll, lll , lV studies (Conclusions of the study)
