COFEPRIS, the Mexican Regulatory Authority, has different verticals. One such vertical is the NMC. NMC stands for ‘’New Molecule Committee’’. It reviews the data and information on new molecules.
Drugs that fall under NMC are:
- New drug substances (new in the world or new to Mexico)
- New combinations of drug substances (for Mexico)
- New indications
- Other special cases (such as similar biotherapeutic products)
The NMC reviews the information on new molecules and issues a report before the manufacturer submits the dossier to the authorities for registration. The dossier must contain the answers to the queries from the NMC.
Meetings with NMC
Meetings with NMC can be requested in a written form of free-style writing, as there is no pre-defined format. The request should include the following information:
- Reason for the request
- Name and address of the manufacturer
- ICC name of the drug
- Commercial name or brand name
- Pharmaceutical form, concentration, strength, and route of administration
- Therapeutic indication
- A summary of the mechanism of action of the drug
- Whether clinical studies on the Mexican population are available, indicating the number and title of protocol and status (ongoing or finished)
- Under which category would the drug be considered a new molecule
- Proposal of the possible meeting date, considering that after the date, the manufacturer should be available to present to the NMC
Generally, the meeting with NMC is scheduled in four (04) to six (06) months and no fees are included for the meeting.
The manufacturer can also arrange a meeting with the NMC during the product’s development phase. Manufacturers can have as many meetings as they want with NMC.
COFEPRIS, aka the Federal Commission for Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios), sends a clear and detailed document containing instructions about how to send and present the documents. The documents must be shared in the Mexican Spanish language only.
The meeting begins with a presentation by the company, which can be in any language if there is an interpreter. There is no specific requirement for the people attending the meeting. Experts from medical, clinical, and CMC teams must answer specific queries and clarifications. Company representatives with clarity of product concept, vision, and mission must be present in the meeting. Everything discussed within the NMC is confidential.
Mexico’s pharmaceutical market is highly regulated and is controlled by different organizations within the COFEPRIS. With a team of highly qualified professionals, Freyr can help you with end-to-end Regulatory services in Mexico.Consult Freyr today!