Overview
In Mexico, manufacturers who seek market authorization (Sanitary Registration) for their new drug must first request approval of their products as new molecules from the New Molecules Committee (NMC) of COFEPRIS. The NMC was established by COFEPRIS to reduce review timelines about the pre-submission discussions of product development, clinical trial and dossier.
What is a New Molecule?
According to article 2, section XV Health Law Regulations a New molecule is considered;
- An active ingredient or drug not approved worldwide (new molecular entity);
- An active ingredient or drug already available in other countries but with limited clinical experience or disputed information, without approval in Mexico;
- A drug which is a non-marketed combination of two or more active ingredients; and
- An active ingredient or drug already available in the market, but to be marketed for a new therapeutic indication.
New Molecule Application Steps
Content of NMC meeting request:
The applicant should request NMC and technical meetings through the Center for Integrated Services (Centro Integral de Servicios, CIS). All documents should be prepared in Spanish ( Mexican Spanish). The format for request meeting with the NMC is referred in Mexico as free-style writing. Free- style writing just means there is no pre-established form or format.
The request should include the following information:
- Reason for the request
- Applicant name, address and telephone and fax numbers of manufacturers and/or representatives of manufacturers.
- Generic name
- Brand name
- Dosage form, concentration, strength, and route of administration
- Therapeutic indication
- Summary of mechanism of action of the drug
- Protocol no. and title and current status( finished or ongoing ) of the clinical trial conducted with Mexican Subjects.
- Evaluation Route (Scope of New Molecule)
- Proposal of possible meeting date
Meeting Requests to NMC:
Evaluation Route and Prior Registration in a reference country determines whether or not the applicant is eligible for in-person or a distance meeting.
Reference Countries for New Molecules :
- Food and Drug Administration of the United States of America (FDA).
- Swiss Agency for Therapeutic Products (Swissmedic).
- Therapeutic Goods Administration of Australia (TGA).
- Health Canada (HC).
- European Medicines Agency (EMA)
Evaluation Route | Prior Registration in Reference country | Request type accepted from NMC |
First global registration | NO | In-person meeting |
New Registration in Mexico
| YES | Distance meeting |
NO | In person Meeting | |
New Fixed dose combination | YES | Distance meeting |
NO | In person Meeting | |
New therapeutic indication (includes the extension of the therapeutic indication to age groups, change of position in the treatment line): | YES | Distance meeting |
NO | In person Meeting |
Evaluation Route
Prior Registration in Reference country
Request type accepted from NMC
First global registration
X
In-person meeting
New Registration in Mexico
ü
Distance meeting
X
In person Meeting
New Fixed dose combination
ü
Distance meeting
X
In person Meeting
New therapeutic indication (it includes the extension of the therapeutic indication to age groups, change of position in the treatment line):
ü
Distance meeting
X
In person Meeting
Who should attend the NMC meeting?
All the people considered necessary are allowed to attend the meeting however, a maximum number of 10 people is set.
It is recommended to have the following people at the meeting:
- Advisors and Experts
- Mexican Registration Holder
What language is the meeting conducted in?
The company presentation and the discussions should all be in Spanish. For foreign companies, it is recommended to have an interpreter to convey information during the meeting.
NMC Review Timelines:
The NMC meeting is held on average within six (6) months from the date of request.
NMC Fees:
There are no fees for requesting the NMC meeting.
What happens after the meeting with NMC ?
After the meeting the NMC will issue the Technical Opinion within 20 business days. Once the NMC issues the Technical Opinion, the user will be able to submit their request for sanitary registry to COFEPRIS. It should be noted that the Technical Opinion issued by the NMC is not binding and it does not imply authorization of the Sanitary Registry by COFEPRIS.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.