Cofepris | Mexico | Regulatory | global regulatory partners

Medical Devices

Mexico’s Regulatory Health Authority:

Medical Devices are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). All medical devices imported into or distributed within Mexico must first undergo registration with COFEPRIS.

Cofepris Medial Device Definition:

“a the substance, mixture of substances, material, apparatus or instrument (including the computer program necessary for its appropriate use or application), used alone or in combination for the diagnosis, monitoring or prevention of diseases in humans or in the treatment of the same and of the disability, as well as those used in the replacement, correction, restoration or modification of the anatomy or human physiological processes.”

Medical Device Registration in Mexico:

Registering a device or IVD in Mexico can be extremely difficult for non-Spanish speakers. COFEPRIS, the regulatory authority that oversees medical device and IVD registration , provides  very limited information  on their website in English, furthermore, they require all documentation and communication to take place in Spanish. GRP office located in Mexico City has a team of bilingual regulatory experts that can help you access Mexico’s medical device market.

More Resources:

Authorized local agent

Mexican Health Authority (COFEPRIS) requires that any foreign pharmaceutical or biologic company, without a physical location in Mexico, to appoint a Mexican Registration Holder in Mexico before registering and selling any product in Mexico. In Mexico, GRP Mexico office is licensed by COFEPRIS to act as your Local Representative in Mexico.

GRP-Mexico Local Agent Services:

  • Communication with COFEPRIS
  • Product Registration
  • Assistance with COFEPRIS inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support COFEPRIS consultation meetings.
  • Recall or incident report assistance 
Cofepris | Mexico | Regulatory | global regulatory partners

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Mexico.

Regulatory Intelligence| Global Regulatory Partners Inc.

Regulatory Strategy

Registering your medical device for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada or Japan qualify for expedited review by COFEPRIS. However, registering a device or IVD in Mexico can be challenging. Little information on the registration process is available in English from COFEPRIS, the division of the Mexican Ministry of Health (Secretaría de Salud) responsible for medical device and IVD oversight.

GRP’s consultants know how to combine the classification and grouping documents with years of practical experience working with COFEPRIS to help you find the optimal and most cost-effective registration strategy, based on your company’s needs and goals for the market.

GRP Regulatory Strategy Services (Mexico):

  • GRP can determine the proper classification for your medical device and can provide an initial assessment on grouping acceptability, if necessary.
  • Many manufacturers work with us on standard Third-Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
  • Our in-depth knowledge of the Mexican medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.
  • We can assist you in preparing medical device registration documents that demonstrate compliance with COFEPRIS.
  • Our Mexico Registration Holder services allow us to submit devices for COFEPRIS approval on your behalf.
Regulatory Affairs | Global Regulatory Partners

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration.  Our Regulatory affair’s team helps medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements of COFEPRIS in order to successfully register and commercialize their products in the Mexican market and maximize the value of their assets.

Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory operations, and publishing
  • Product registration
  • Registration amendments
  • Consulting meetings with regulatory authorities

Product registration

COFEPRIS classifies medical devices into four categories based on risk to the patient. Table 1 summarizes the 4 Device Classes and their associated risk description. Table 2 summarizes various registration pathways for Medical Devices.

TABLE 1: MEDICAL DEVICES CLASSIFICATION

Device Class Description
Class I Lowest Risk
Class IA Low Risk
Class II Medium Risk
Class III Devices High Risk

Table 2: MEDICAL DEVICE Registration Pathway

Registration Pathway Description Application Requirements
Equivalency Review Process If your device has been approved in the US, Canada or Japan, you may qualify for an equivalency review

Equivalency reviews require the submission of a Summary Dossier with less detailed technical information, and initial registration may be faster than the standard review process
US, Canada Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements – Product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling with instructions for use.
Japan Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements • Notification of Exportation • Original Certificate of Free Sale with codes; no older than one year • Certification issued by the Registered Certification Body or MHLW: – Description – Indications for use – Formula and/or composition, if applicable – Stability information, if applicable – Sterility period, if applicable – Primary and secondary packaging information, if applicable – Compliant labeling, instructions for use.
Standard Review to register through the standard review process, you must prepare a detailed Registration Dossier that includes full product technical information and applicable testing results.

Applications going through the standard review process are also eligible for Third Party Review, which has the potential to expedite the approval process, and incurs additional cost to pay for the third-party reviewer.
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof of home country approval – Detailed product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling, instructions for use
Class IA Low risk device registration Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Compliant labeling, instructions for use.

GRP-Mexico IVD/Device Registration Services:

  • Act as your Mexico Registration Holder
  • Determine classification of your medical device or IVD
  • Help you determine the proper regulatory pathway for your devices
  • Inform you of the documentation required within the applicable registration route.
  • Help you determine a grouping strategy for your registration
  • Prepare and submit registration application documents to COFEPRIS
  • Coordinate translation of submission materials into Spanish
  • Work to answer questions from COFEPRIS during the submission process

Medical writing

Medical writing | Global Regulatory Partners

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules

Health authority consultation

Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan. Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with COFEPRIS heath authorities before starting key milestone of your product development.

GRP Regulatory Affairs  Support Team Services:

  • Prepare and submit of the meeting package to the health authority
  • Prepare the questions to health authority based on the status of your product’s development and future plan
  • Provide support during the meeting
  • Write the meeting minutes and develop the appropriate action plan after the consultation meeting.  
meeting | health authority

Clinical Trials

Clinical Trials in Mexico are known as Ensayos Clínicos. Clinical trials authorizations with the purpose of registering a pharmaceutical product are requested based on the type of research, the origin of the product or the research procedure. Applicants may submit the documents to gain authorization to perform Clinical Trials/Human Subjects Research Protocol directly to Cofepris or request a preliminary evaluation report to a UHAP (support units enabled to emit preliminary report).

UHAP Evaluations:

UHAP evaluations are voluntary. Contact method and costs are not standardized among UHAPs. The preliminary report attached to the file submitted to Cofepris may speed up the processing process. Applications including UHAP reports may be issued in up to 30 business days.

Figure 1: Clinical Trial Application Process:

Figure 2: Clinical Trial Protocol Authorization Process

Table 1: Submission Material

Module

Included Documents

I

  • Application Form and/or Escrito Libre (Detailed Cover Letter with Product Specifications)

 

II

  • Proof of payment – Original and 2 copies

 

III

  • Letter accepting research involvement and responsibilities of researcher(s)/sponsor(s) expressing also prevention measures of conflict of interests, especially if there is monetary compensation involved.
  • Letter issued by the CRO/sponsor describing the human resources and materials to be destined in the research in all research sites.
  • Letter from the sponsor with a monitoring/auditing plan

 

IV

  • Research Protocol
  • Informed Consent Letters
  • Timeframe/Schedule

 

V

  • Ethics Committee Certificate (Copy)
  • Research Committee Certificate (Copy)
  • Research and Ethics Committee Approval Report
  • Research Committee Approval Report

 

VI

  • Other requested by current health regulations in the field of research for human health

 

GRP Clinical Trial Services (Mexico):

  • Clinical Trial Consulting Services

    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support

    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Mexico. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate  regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management

    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits

    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance

    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Research Protocol Forms

COFEPRIS 04-010 A: Pharmaceutical Products (Biologics and Biotechnological) Cost: $ 5,880 MXN

COFEPRIS 04-010 B: Pharmaceutical Products (Bioequivalence Studies) Cost: $5,880 MXN

COFEPRIS 04-010 C: New Resources (Materials, grafts, transplants, prostheses, physical, chemical procedures and other methods of prevention, diagnosis and treatment) Cost: $5,880 MXN

COFEPRIS 04-010 D: Risk-free Research (Observational studies that employ techniques, methods of  documentary research and those in which no intervention or intentional  modification is made in the physiological, psychological and social variables of the  research subjects) Cost: $5,880 MXN

Registration Timelines:

Requests submitted directly to Cofepris, for any Research Protocol (clinical trials) unless having preliminary report from a UHAP, are taking an estimate of 90 business days for processing.

Quality

Implementing and maintaining a quality management system (QMS)

Implementing and maintaining a quality management system (QMS) is a crucial part of regulatory compliance for most markets worldwide. For small medical device manufacturers in the pre-production phase, an initial implementation of a partial quality system is an extremely beneficial way to ensure compliance with product development regulations, such as Design Controls. Pre-production QMS for eventual compliance with FDA QSR and ISO 13485.

While a quality system typically does not have to be fully implemented until you begin your medical device registration, implementing an initial partial QMS system can make implementing a full QMS less burdensome, and may shorten your time to commercialization in the long run.

Pre-Production QMS:

A pre-production QMS is ideal for medical device manufacturers that are 18-24 months away from commercialization and distribution.  The benefit for this approach is to allow the organization to build and improve their quality system as they proceed through design and development, validation testing, conducting clinical trials, and eventually market launch.

 

Compliance with design control procedures.

The US Food and Drug Administration (FDA) and other market regulators including COFEPRIS require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.

To ensure ongoing compliance with quality system procedures, you should;

  • evaluate your pre-production QMS using internal audits at least once a year.
  •   Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.

 

GRP Extensive Quality Experience:

GRP has extensive expertise helping companies worldwide establish quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements including COFEPRIS . Our experienced consultants can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering. We can also perform internal quality system audits if you do not have the staff or resources to do so.

GRP QMS implementation Services:

  • Document and records control
  • Training on regulatory requirements and internal procedures
  • Design and development
  • Risk management
  • Software development (if applicable)
  • Supplier evaluation
  • Control of measurement equipment
  • Perform internal quality system audits

Pharmaceuticals

Mexico’s Health Authority:

Pharmaceuticals in Mexico are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). 

Cofepris Drug Definition:

According to Article 221, Section I of the General Health Law a drug is defines as;

“Any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive or rehabilitative effect, that is presented in a pharmaceutical form and is identified as such by its pharmacological activity, physical, chemical and biological characteristics. When a product contains nutrients, it will be considered a medicine, as long as it is a preparation that contains individually or in association: vitamins, minerals, electrolytes, amino acids or fatty acids, in concentrations higher than those of natural foods and it is also present in some defined pharmaceutical form and the indication of use contemplates therapeutic, preventive or rehabilitative effects.”

New Molecule Definition:

“Active Principle of a medication, of natural or syntetic origin, not previously used in the country and whose efficacy, safety and therapeutic purposes have not yet been completely reported in the scientific literature.

GRP Pharmaceutical Services:

Through our local office in Mexico, GRP can act as your local authorized agent in Mexico and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.

More Resources:

Authorized local agent

Mexican Health Authority (COFEPRIS ) requires that any foreign pharmaceutical or biologic company, without a physical location in Mexico, to appoint a Mexican Registration Holder in Mexico before registering and selling any product in Mexico. 

GRP- Mexico office is licensed by COFEPRIS to act as your Local Representative in Mexico.

GRP-Mexico Local Agent Services:

  • Communication with COFEPRIS
  • Product Registration
  • Assistance with COFEPRIS inspection
  • Adverse Effect Reporting
  • Support Importation Process
  • Organize and support COFEPRIS consultation meetings.
  • Recall or incident report assistance 
Cofepris | Mexico | Regulatory | global regulatory partners

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. 

At Global Regulatory Partners,  our team of professionals in Mexico can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular needs in Mexico.

Regulatory Strategy

Registering your product for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada or Japan qualify for expedited review by COFEPRIS.

However, registering a product in Mexico can be challenging. GRP’s consultants know how to combine the classification and grouping documents with years of practical experience working with COFEPRIS to help you find the optimal and most cost-effective registration strategy, based on your company’s needs and goals for the market.

GRP Regulatory Strategy Services ( Mexico):

  •  Determine the proper classification for your product and can provide an initial assessment, if necessary.
  • Work with us on standard Third-Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
  • Provide the most efficient and cost-effective regulatory approval strategy for your device.
  • Assist you in preparing registration documents that demonstrate compliance with COFEPRIS.
  • Submit device registration to COFEPRIS for approval.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP Inc. regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product registration, products’ life cycle management and maintenance.

GRP Regulatory Affairs Services:

  • Regulatory Intelligence (RI)
  • Regulatory Strategy
  • Regulatory Operations and Publishing
  • Product Registration
  • Products’ life cycle management and maintenance.
Regulatory Affairs | Global Regulatory Partners

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in Mexico. GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of COFEPRIS eCTD requirements.

GRP Compliance:

GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

GRP Regulatory Operation Services:

  • consulting services
  • planning and assembly of submissions
  • document creation and approval
  • e-Submission
  • roadmap compliance,
  • publishing,
  • viewing and navigation
  • archiving
  • submission process optimization
  • tracking and lifecycle management.

Product registration

Figure 1: Registration Pathways of Pharmaceuticals in Mexico

Application Process:

The formal application process starts when a pharmaceutical company takes the compilation of documents known as the application dossier to the COFEPRIS office.

Deficiency Letters:

The reviewers at the COFEPRIS will read everything very thoroughly and will address any question they might have about the data on the dossier in the form of a letter, commonly called deficiency letter, officially called prevención in Mexico. Deficiency letters are not always issued, and most of them can be avoided by following all the guidelines, submitting complete information, and avoiding common silly mistakes.

“NEw Molecule”

If your product falls into the category of ‘new molecule’, you have to request a meeting with the New Molecule Committee before submitting the application.

Cases Considered as a “New Molecule”

  1. New drug substances (new in the world or new for Mexico)
  2. New combinations of drug substances (for Mexico)
  3. New indications
  4. Other special cases (e.g. similar biotherapeutic products)

Up until recently, the average application could take anything between 1 and 4 years to be reviewed and approved. With some key changes implemented lately, such as the pre-revision process by Third Authorized Parties, or the Agreement for Innovation, timelines are decreasing dramatically, to just some months to a year.

Market Authorization (MA) Timeline:

The marketing authorization is granted for a period of five years. Submission for registration renewal must be filed at least 6 months before expiry.

Table 2: MEDICAL DEVICE Registration Pathway

Registration Pathway Description Application Requirements Timelines
Equivalency Review Process If your device has been approved in the US, Canada or Japan, you may qualify for an equivalency review

Equivalency reviews require the submission of a Summary Dossier with less detailed technical information, and initial registration may be faster than the standard review process
US, Canada Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements – Product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling with instructions for use.
APPLICATION

US
3-8 months

CANADA
3-8 months
——
VALIDITY PERIOD
5 Years
Japan Equivalency:
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof that device meets equivalency requirements • Notification of Exportation • Original Certificate of Free Sale with codes; no older than one year • Certification issued by the Registered Certification Body or MHLW: – Description – Indications for use – Formula and/or composition, if applicable – Stability information, if applicable – Sterility period, if applicable – Primary and secondary packaging information, if applicable – Compliant labeling, instructions for use.
APPLICATION

Japan
3-8 months
——
VALIDITY PERIOD
5 Years
Standard Review to register through the standard review process, you must prepare a detailed Registration Dossier that includes full product technical information and applicable testing results.

Applications going through the standard review process are also eligible for Third Party Review, which has the potential to expedite the approval process, and incurs additional cost to pay for the third-party reviewer.
Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Proof of home country approval – Detailed product information, including: • Materials information • Manufacturing process • Testing completed • Sterility information, if applicable • Expiration date, stability studies, if applicable • Clinical data, if applicable • Compliant labeling, instructions for use APPLICATION

Standard Review
3-6 months
——
VALIDITY PERIOD
5 Years
Class I Lowest risk device registration Application Form, plus: – Proof of payment, based on COFEPRIS classification – MRH documentation – Compliant labeling, instructions for use. APPLICATION
1-3 months
Registration Renewal Should be started 12 months in advanced}. (applies for all categories)

Quality

The Directorate for the Evaluation of Processes for the Pharmaceutical/Chemical Industry (DEPIQF) of the COFEPRIS is responsible for regulating the establishments dedicated to the manufacture of medicinal products. The Directorate also regulates medicinal products classified as controlled substances for the evaluation of medicinal products of the COFEPRIS.

GRP-Mexico Quality services:

  • assist you for GMP compliance per Mexican Requisites.
  • Inspection is necessary before submission of the dossier.

COFEPRIS conducts GMP verification:

The GMP certificate is issued to each manufacturing site in compliance with GMP, after inspection of the relevant authority. The certificate is the only document that states the GMP compliance and is valid only for the time indicated on the certificate. A valid GMP certificate should be submitted to the regulatory authority when the applicant submits a request for a new product registration, to renew or modify an existing one.

  • For new registration and manufacturing changes of biologic, biotech and hemo-derivate products.
  • For new registration or renewal of drug products or drug substances of any kind manufactured in countries not considered as high sanitary surveillance by COFEPRIS.
  • Drug product and Drug substance manufacturing sites are inspected.

Equivalent GMP Certificates:

The following GMP Certificates are accepted by Cofepris.

  • FDA (USA)
  • ANVISA (Brazil)
  • Health Canada (Canada)
  • EMA (EU)
  • Pharmaceutical and Food Safety Bureau (Japan),
  • Therapeutic Goods Administration (Australia)

GMP certificates issued by the authorities of the countries mentioned above must be accredited or notarized copies, and must be with a statement confirming that the certificate is authentic and was issued in accordance with related laws and regulations in Mexico.

GMP requirements for API manufacturers:

Manufacturers of active pharmaceutical ingredients (APIs) for medicinal products and clinical investigations have to comply with the Official Mexican Norm NOM-164-SSA1-2015. 

The content of an API GMP file is very similar to the Drug Master File (DMF). The content of the Manufacturing Site Master Records is fully described in NOM-164-SSA1-2015.

Inspection request submission Material:

  • Submit form and required documents
  • Propose two inspection dates (production of DS/DP) and inspection schedule
  • Propose hotel and flight options. Cost of visit + travel expenses: company
  • Arrange a Spanish translator
  • Timeline to get an inspection: about 3 months

Clinical

Regulation:

The primary legislation for conducting clinical trials in Mexico is the Health Law Regulations for Health Research (Reglamento de la Ley General de Salud en Materia de Investigación para la Salud) (RLGSMIS) and the NOM for Health Research in Human Beings.

Cofepris | Mexico | Regulatory | global regulatory partners

figure 1: Clinical Trial Application Process

Figure 2: Clinical Trial Protocol Approval Process in Mexico

GRP’s Clinical Trial Services (Mexico):

  • Clinical Trial Consulting Services

    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support

    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Mexico. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management

    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits

    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance

    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

GRP Clinical Trial Expertise in Mexico:

An understanding of the regulatory requirements in Singapore and experience in dealing with the local regulatory authorities (Cofepris) is essential in administering a smooth, successful clinical trial in Mexico. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in Mexico. Our local teams and affiliated partners located in Mexico and all-around LATAM are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

Local clinical studies required by COFEPRIS:

  • New molecules
  • Biotech and biocomparable products
  • Generic drugs that are not commercialized anywhere else in the world.
  • Other cases upon authority request

Pharmacovigilance Studies on Mexican Hispanic Populations:

Pharmacogenomic studies have shown that drug metabolism in Mexican-Hispanic population can be influenced by its genetic makeup. 

When clinical studies are multicentric, Mexican population must be included. If Mexican patients are not included in the clinical trials: New Molecule Committee will request pharmacokinetic studies to evidence not significant differences in safety or efficacy in Mexicans.

Research Protocol Forms

COFEPRIS 04-010 A: Pharmaceutical Products (Biologics and Biotechnological) Cost: $ 5,880 MXN

COFEPRIS 04-010 B: Pharmaceutical Products (Bioequivalence Studies) Cost: $5,880 MXN

COFEPRIS 04-010 C: New Resources (Materials, grafts, transplants, prostheses, physical, chemical procedures and other methods of prevention, diagnosis and treatment) Cost: $5,880 MXN

COFEPRIS 04-010 D: Risk-free Research (Observational studies that employ techniques, methods of  documentary research and those in which no intervention or intentional  modification is made in the physiological, psychological and social variables of the  research subjects) Cost: $5,880 MXN

Cosmetics

Mexico’s Regulatory Health Authority:

Cosmetics are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). 

Cofepris Cosmetic Definition

In Mexico, cosmetics are defined as “Products intended to be brought into contact with the parts of the human body to clean, perfume, help and with the principal purpose of cleaning, perfuming, helping to modify their appearance, protecting, keeping in good condition, correcting body odors or reducing alterations in the functioning of healthy skin.”

GRP Cosmetic Services:

Global Regulatory Partners Inc. (GRP) office in Mexico City provides end-to-end regulatory affairs services for cosmetics that include: regulatory intelligence, regulatory strategy, product classification, formulation review, claim assessments and labeling assessment in compliance with COFEPRIS requirements.  

Through our local office in Mexico, GRP can act as your local authorized agent in Mexico and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing strategic advice concerning product classification from products’ development till commercialization.

More Resources:

Authorized local agent

Global Regulatory Partners Inc. (GRP) has local offices in Mexico and is licensed by the COFEPRIS to act as your authorized local agent for your Cosmetic and Personal Care Products. GRP- Mexico team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and PCPs. GRP-Mexico helps manufacturers, distributors, and marketers of cosmetics in Mexico.