Author: DANIEL VILLENA

Medicine Warehouses: When is a Sanitary License required, and when is an Operating Notification needed?

Post author By DANIEL VILLENA
Post date 20 September, 2024

Modern pharmacy storage room and a robot hand is arranging and storing out drugs in a pharmacy.

Companies that distribute and market medicines for human use within national territory must have a warehouse to store the medicines they are authorized to hold, distribute, and/or sell. This warehouse must be duly registered and authorized by COFEPRIS.

Every time a warehouse for human-use medicines is established, the first step is to determine whether the warehouse requires an Operating Notification or a Sanitary License to start operations. This will be defined by the type of medicines that will be stored.

	Types of medicines that will be stored/distributed/marketed.
Sanitary License	Medicines containing narcotics (Section I) Medicines containing psychotropics (Sections II and III) Medicines containing toxoids, serums, animal-origin antitoxins Blood derivatives Vaccines Warehouses performing primary or secondary conditioning of medicines (any type)
Operating Notification	Medicines or biological products that do not contain narcotics and/or psychotropics, toxoids, serums, animal-origin antitoxins, blood derivatives, or vaccines (Sections IV, V, VI), such as: Allopathic medicines Vitamin medicines Herbal medicines Homeopathic medicines

It’s important to understand that an Operating Notification is not the same as a Sanitary License for a human-use medicine warehouse, and there are substantial differences in their application processes.

Operating Notification

An Operating Notification for a medicine warehouse, as its name implies, is a notification to the sanitary authority in which the company indicates that it will open a warehouse, providing the exact location, the start date of operations, and the activities to be carried out, for example, room temperature storage, room temperature transportation, distribution, etc.

To submit the Operating Notification, legal documents related to the company registering the warehouse are required (articles of incorporation, power of attorney, legal representative’s ID, among others), as well as the sanitary responsible’s credentials, such as their professional license, ID, etc. Since it is an electronic process, it must be signed by the concerned parties using the digital signature (e-signature) provided by the Tax Administration Service (SAT), and it must be submitted at least 30 days before operations start.

Filing an Operating Notification implies that the company is prepared for a potential inspection by the authority and already has a quality system in place as outlined in the Pharmacopeia Supplement for Warehouses of Sanitary Supplies.

Sanitary License

For warehouses that require a sanitary license, it is important to note that the warehouse cannot begin operations until the Sanitary License has been authorized.

The process is as follows:

First, a Sanitary Responsible Notification for the establishment is submitted.
A Sanitary License application is then submitted to Cofepris, specifying the operations to be carried out in the warehouse, the types of medicines to be handled, and the warehouse location. This Sanitary License application involves a verification visit to the warehouse facilities and infrastructure, as well as to the Quality Management System, which must be overseen by the sanitary responsible, who must be available on the inspection day, as indicated by NOM-059-SSA1-2015.
On the inspection day, the inspector will arrive with a verification order and identification, and the user can confirm if the inspector is registered with the Sanitary Operation Commission of COFEPRIS on the following page: https://www.gob.mx/cofepris/documentos/listado-de-verificadores-sanitarios-de-insumos-para-la-salud to avoid simulated inspections by fraudulent inspectors.
During the visit, the inspector will assess the Quality Management System, as well as compliance with NOM-059-SSA1-2015, and will record their evaluation in a verification report. After reviewing each point of the report, the inspector will inform the sanitary responsible of any observations.
Before signing the verification report with the inspection results, the company has the right to include comments or disagreements in the report, and it also has 5 business days after signing to submit any necessary information to COFEPRIS that may address any deviations.
COFEPRIS may issue a request for additional documents or information, and even request a follow-up inspection.
Once all issues have been satisfactorily resolved, COFEPRIS will authorize the Sanitary License.

Finally, it is important to note that, regardless of whether a warehouse requires an Operating Notification or a Sanitary License, it must have the appropriate facilities, infrastructure, and Quality Management System in accordance with the type of operations to be performed and the products to be stored (as established in NOM-059-SSA1-2015 and the Supplement for Establishments dedicated to the sale and supply of medicines and other sanitary supplies of the FEUM) before starting operations.

Based on all the above, the key is to clearly define the type of medicine to be stored and the activities to be carried out in the warehouse to determine the type of authorization needed to begin operations, if you have any question about this in Rafconsulting we will be glad to help you get your documents and your establishments in order.

Pharmacovigilance

Do you know how to report adverse drug reactions (ADRs) notifications?

Post author By DANIEL VILLENA
Post date 14 August, 2024

Megaphone icon with speech bubble in word adverse event on white background

Cofepris, in an attempt to encourage the reporting of adverse reactions by consumers and healthcare professionals, launched a new platform for notifications. This new platform is called VigiRam, which promises to be more user-friendly for the notifier and avoids discouraging the reporting process.

VigiRam is an application that can be installed on a mobile phone; it contains the complete electronic standardised format for reporting suspected adverse drug reactions. Notifications sent through this platform are encrypted and transmitted directly to the National Pharmacovigilance Center (CNFV).

VigiRam allows data/information capture without an internet connection, and it does not require users to register or create an account to use the tool; however, an internet connection is required to submit the captured information. It is important to mention that it allows sending notifications with the minimum required information. Each time a notification is sent, the application will confirm that the information was sent successfully and provides receipt acknowledgment.

This new method for reporting adverse reactions appears to be a more user-friendly tool compared to an email address or a phone call, which can take several minutes, and many people tend to avoid answering calls of uncertain duration.

The challenge now is to promote this tool among healthcare professionals and health institutions to encourage consumers to report adverse drug reactions in Mexico, which will help optimise drug safety.

You can download the information here:

Medical devices

The Medical Device Single Audit Program (MDSAP) in Mexico: A Revolutionary Initiative in Medical Device Regulation

Post author By DANIEL VILLENA
Post date 5 August, 2024

The Medical Device Single Audit Program (MDSAP) represents a significant collaboration in the field of international health regulation, designed to improve the efficiency and effectiveness of the audit process in the medical device industry. This initiative was developed by the International Medical Device Regulators Forum (IMDRF) and aims to simplify the regulatory compliance process for manufacturers globally.

MDSAP allows medical device manufacturers to undergo a single audit of their quality management systems and Good Manufacturing Practices compliance, conducted by an IMDRF-authorized and recognized auditing organization. The results of these audits are accepted by all participating program members (United States, Canada, Australia, Japan, and Brazil) as if the Good Manufacturing Practice certificates were issued by the Ministry of Health, thereby facilitating access to multiple international markets under a unified set of evaluation criteria.

Benefits of MDSAP Membership

Countries participating in MDSAP enjoy several key benefits:

Mutual Recognition of Audits: This allows for greater consistency and predictability in audit outcomes, reducing redundancy and regulatory burden for manufacturers.
Resource Optimization: Both regulatory authorities and manufacturers can better allocate their resources by avoiding multiple independent audits.
Standardization of Standards: The program promotes uniformity in safety and quality standards, raising the overall level of products available in the global market.

Commitments of Participating Regulatory Agencies

By adhering to MDSAP, regulatory agencies commit to:

Accept and respect the audit reports generated under MDSAP, ensuring effective collaboration and mutual trust among member countries.
Contribute to the ongoing development and improvement of the program, including regular updates to audit criteria to accommodate technological advances and new regulatory challenges.
Promote the adoption of global regulatory practices, thereby facilitating a safer and more effective environment for health products worldwide.

Mexico’s Membership in MDSAP

Mexico’s affiliation with MDSAP, confirmed on November 2, 2023, marks an important milestone in its trajectory as a global health regulator. Through COFEPRIS, Mexico has demonstrated its commitment to adopting international standards and strengthening international cooperation to ensure the safety and effectiveness of medical devices. This achievement not only enhances national public health protection but also significantly contributes to global well-being, positioning Mexico as a proactive leader in the harmonization of international health regulation, and favors trade and authorization of new products.

As an affiliated member of MDSAP, COFEPRIS is responsible for recognizing MDSAP audit results through the presentation of a valid MDSAP certificate as equivalent to the Good Manufacturing Practice Certificate issued by this regulatory entity for the purposes of sanitary registration in Mexico. That is, a company that manufactures products in Mexico for sale in this country can present the MDSAP certificate for registration purposes without requiring one issued by COFEPRIS, and this authority will accept it.

Sources:

International Medical Device Regulators Forum (IMDRF): Documents and publications related to MDSAP.
Federal Commission for the Protection against Sanitary Risks (Cofepris): Official communications on Mexico’s membership in MDSAP and its implications.
Specialized publications in health regulation and medical devices: Articles discussing the implementation and benefits of MDSAP.

Medical devices

Health 4.0: Do You Know the Concept?

Post author By DANIEL VILLENA
Post date 31 July, 2024

Revolutionising the Medical Device Industry

What is Health 4.0?

Health 4.0 is a concept that arises from the fourth industrial revolution, or Industry 4.0, which integrates advanced technologies such as Artificial Intelligence (AI), the Internet of Things* (IoT), Big Data, and robotics to transform healthcare services. This new era is characterized by the digitization and connectivity of healthcare systems, improving the efficiency, accuracy, and personalization of medical treatments. The adoption of these technologies aims not only to optimize medical processes but also to provide more preventive and predictive care.

This term has had a significant impact in the health field and has quickly permeated the Medical Devices industry, enabling:

Remote Monitoring: Connected devices can send real-time data to healthcare professionals, improving the management of chronic diseases.
Accurate Diagnostics: AI and Big Data assist in interpreting medical images and analyzing data, reducing errors and improving diagnostics.
Personalized Care: Personalized medicine becomes more accessible by analyzing large volumes of data to tailor treatments to each patient’s specific needs.
Operational Efficiency: The automation of processes and the use of robots in surgery and other medical procedures improve precision and reduce recovery times.

The development of Health 4.0 has been driven by advances in various technologies and the growing demand for more efficient and effective healthcare services. From the use of wearable devices that monitor health to the implementation of AI-based hospital management systems, the evolution has been rapid and promising. Countries such as the United States, Germany, and Japan have led this transformation, integrating these technologies into their healthcare systems with notable success.

Health 4.0 Goals

The main goals of Health 4.0 include:

Improving the quality of healthcare.
Reducing operational and treatment costs.
Promoting preventive medicine.
Facilitating access to healthcare services in remote areas.
Increasing patient satisfaction through personalized care.

What is the situation of Health 4.0 in Mexico?

In Mexico, the concept of Health 4.0 is beginning to gain ground. Although still in its early stages compared to other countries, important steps are being taken. Institutions such as the National Institute of Public Health (INSP) and private sector companies are investing in Health 4.0 technologies. Pilot projects in telemedicine, the implementation of Electronic Health Records, and the use of connected medical devices are demonstrating the potential benefits of these innovations.

Although our health regulatory entities have started to adapt regulatory frameworks to incorporate new technologies, there is still a need to adapt or generate new standards to have a regulatory framework that allows us to authorize safe, effective, and quality new technology products and stay at the forefront of digitalization.

Actions taken so far include specific guidelines that COFEPRIS has developed for evaluating emerging health technologies, including the assessment of safety, efficacy, and quality of devices based on new technologies such as Software as a Medical Device and the requirements for obtaining their Health Registration. This has been included in the recent NOM 241 and now in the pharmacopoeia supplement for medical devices.

The integration of new technologies also presents regulatory challenges; and to achieve significant progress, regulatory entities in Mexico and the regulated sector must work closely to ensure their products comply with current regulations and anticipate future regulatory changes, such as:

Mexican Official Norm NOM-241-SSA1-2012: Companies must ensure that connected devices and those based on Health 4.0 technologies comply with Good Manufacturing Practices requirements for medical devices.
Mexican Official Norm NOM-240-SSA1-2012: It is crucial to ensure that connected devices that collect and transmit real-time data comply with medical device Surveillance and adverse event reporting requirements.
Regulation of Health Supplies: This regulation should include procedures for the authorization and surveillance of these medical devices in Mexico. It is important to work on updates to include the specifications of Health 4.0 devices, especially those employing AI and Big Data; we hope the ongoing modification will include them.
General Health Law: With the proposal for the implementation of Electronic Registrations, it is essential to guarantee patient data protection. It is a great example of the beginning of digital health.

The medical device industry in Mexico is in a crucial position to leverage the benefits of Health 4.0, which represent a significant transformation in the global health sector and offer a unique opportunity to improve the quality of healthcare in Mexico.

The integration of advanced technologies not only promises to make treatments more efficient and personalized but can also reduce costs and improve access to healthcare. While Mexico still has regulatory and implementation challenges to overcome, the advances already made indicate a promising future for the adoption of Health 4.0. Collaboration between regulators, health institutions, and the medical device industry will be crucial to reach the full potential of this technological revolution in healthcare.

*IoT allows these smart devices to communicate with each other and with other internet-enabled devices. Just like smartphones and gateways, a wide network of interconnected devices is created that can exchange data and perform various tasks autonomously.

Medical devices

Do you know the characteristics of a Good Manufacturing Practices Certificate for the application for a Registration of foreign-manufactured Medical Devices in Mexico?

Post author By DANIEL VILLENA
Post date 31 July, 2024

The Good Manufacturing Practices (GMP) Certificate is the legal document that certifies that the company manufactures its products under conditions and practices based on a series of norms and/or standards that ensure the quality, efficacy, and safety of Medical Devices; and that they meet the necessary requirements in compliance with the applicable regulations to produce products with the three indispensable characteristics mentioned above.

Essential characteristics of the GMP Certificate

For a GMP Certificate to be valid in Mexico, it must meet the following characteristics:

Scope of the Certificate: The document must certify the manufacturing line(s) of the product(s) to be registered. It is crucial that the scope of the certificate is clearly defined and matches the products intended to be marketed in Mexico.
Validity of the Certificate: The certificate must be valid at the time of the Registration submission. If the document does not contain an explicit expiration date, the inspection date for issuing the certificate must not exceed 30 months.
Authentication of the Certificate: To guarantee the validity of the certificate, it must be authenticated according to the following procedures:

Legalization: For countries not part of the Hague Convention, the certificate must be legalized by the Mexican consul in the country of origin.
Apostille: For member countries of the Hague Convention, the certificate must be apostilled. The Apostille must be issued only by a competent authority designated by the State of origin of the document.

Note: In the case of ISO 13485 or MDSAP certificates, the Apostille can be issued in the manufacturer’s country or the country of the certifying body.

Language of the Certificate: It can be submitted in Spanish or English. If the document is in another language, a translation by an authorized expert translator in Mexico will be required.
Presentation of the Certificate: The certificate can be submitted in its original format or as a notarized copy in Mexico.

Equivalent Documents

ISO 13485 Certificate – Issued by an authorized body.
MDSAP Certificate – Issued by an authorized body to certify this type of audits.
CE Mark Certificate for medical devices – Issued by an authorized body in the European Union.
Declaration of compliance with Good Manufacturing Practices included in the Free Sale Certificate (FSC) – The FSC must be issued by the Ministry of Health of the issuing country or, where applicable, by the relevant Ministry that regulates the product.

Harmonization with international standards

The characteristics of the GMP Certificate for medical devices in Mexico are aligned with international standards established by organizations such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). This regulatory harmonization facilitates the international trade of medical devices and ensures public health protection globally.

Source:

Pharmacopoeia of the United Mexican States Supplement of Medical Devices 5.0, 2023

Medical devices

Concepts related to the classification of Medical Devices in Mexico

Post author By DANIEL VILLENA
Post date 24 July, 2024

Technical filtration equipment in hand macro

In Mexico, Medical Devices are classified according to the risk involved in their use, for registration purposes, so we have the following three classes:

Class I: Those supplies known in medical practice and whose safety and effectiveness are proven, and generally, they are not introduced into the body.

Class II: Those supplies known in medical practice and that may have variations in the material with which they are made or in their concentration, and generally they are introduced into the body for less than 30 days.

Class III: Those supplies that are new or recently accepted in medical practice, or that are introduced into the body and remain in it for more than 30 days.

These three classes are ruled by the contact time of the MD with the user or patient; however, we have a supplement for Medical Devices of the Pharmacopeia of the United Mexican States that contains 35 specific rules that help us classify an MD for application purposes of the Registration in Mexico.

These rules define criteria that must be considered to determine the class of the MD, and for their correct application, therefore it is necessary to know the following:

The application of these criteria for classification is ruled by the intended purpose of use of the MD.
If several rules apply to an MD, the rule that corresponds to the highest classification is applied.
If an MD is intended to be used in combination with another Medical Device, the classification criteria will apply for each of the products separately.
Software that is part of a Medical Device or influences its operation will be included in the same category.
If an MD is not intended to be used exclusively or mainly on a specific part of the body, the most critical specific use will be considered for classification.

It is important to keep the following concepts in mind when reviewing the rules:

Non-invasive Medical Device: It does not have contact with the patient or only has contact with the patient’s skin.
Invasive Medical Device: Partially or completely penetrates the interior of the body through a body orifice.
Surgical-type invasive medical device: Penetrates the interior of the body through the body surface with a surgical intervention. MDs whose penetration into the interior of the body does not occur through recognized body orifices are also considered.
Body orifice: Any natural opening in the body, the external surface of the eyeball, or a permanently created artificial opening (Example: a stoma).
Implantable Medical Device: Any device that is completely introduced into the body or that replaces an epithelial surface or surface of the eye (they can be partially or absorbed); by surgical introduction, that is intended to remain in the body after the procedure. Any MD that is partially introduced into the human body through a surgical intervention and that remains in the body for more than 30 days is also considered in this category.
Active Medical Device: One whose operation depends on a source of electrical energy or any source of power different from those generated directly from the human body or by gravity, and that works in conversion of that energy; In short, to function, they need to be connected to any power source.
Duration: Time of permanence or contact of the Medical Device with the human body.
Transitory use: Intended to normally be used continuously for less than 60 minutes.
Short-term use: Normally intended to be used for no more than 30 days.
Long-term use: Intended to be used continuously for a period longer than 30 days.

A little more about the classification rules…

Rules 1-4 describe non-invasive Medical Devices:
- Examples:

That is in contact with the skin: Gauze, urine collectors, bandages, dressings, probes for electrocardiograms.

That involves the storage, conduction, and perfusion of blood, body fluids, tissues, liquids, or gases: Blood collecting tubes, hemodialysis machines, bags containing saline solutions.

Rules 5-10 describe invasive Medical Devices.
- Examples: Invasive that involve body orifices in their use: Urinary catheters, gloves, dental implants, and bridges, prostheses.
Rules 11-17 apply to active medical devices, that is, those that are in contact with the human body in the short and long term.
- Examples: Active MD for diagnostic purposes: Ultrasound, oximeter, stethoscope, thermometers, blood pressure devices
- Intended to manage or exchange energy: Tomography, X-ray machines, incubators, and supplies for dental use.
- Software as a medical device: Mobile applications.
Rules 18-23 describe special criteria, for example: for medical devices that are intended to aid the incorporation of a drug product or nanomaterials into the body, MD used for contraceptive purposes or the prevention of sexually transmitted diseases, intended for disinfection or decontamination.
- Examples: Male and female condoms, non-medicated and medicated intrauterine devices, and subdermal implants used as contraceptive methods
Rules 24-33 apply to In Vitro Diagnostic Agents, these will be classified according to their indication for use and the level of risk that an erroneous result could cause serious disability or death of the patient, fetus, or embryo.
- Examples: Contrast media, Diagnostic tests (for HIV, HCV, HTLV, etc.), tests for the detection of markers, reagents, calibrators, and culture media.
Rule 34 describes Hygienic Products
- Examples: antiseptic gel, tampons, lubricants.
Rule 35 refers to low-risk Medical Devices
- Examples: Face masks, surgical masks, body control scales, sheets, and fields for surgical use

In conclusion, we can state that the correct classification of medical devices represents a great challenge, due to the variety of MDs that are on the market and the technological advances that are continually taking place, however, for the registration application it is essential to classify the product in question correctly, since according to this class the payment fees will apply, the requirements demanded by COFEPRIS and we will be able to obtain the registration avoiding the issuance of a deficiency letter due to errors in classification.

Fortunately, we have these 35 rules that represent an important tool, since they provide an orderly and systematized method for the correct classification of a medical device, taking into account the intended use of the product, the contact time with the body, if it is required energy for its use, if it emits any type of energy for therapeutic purposes (p.e. x-rays), if it is introduced into the body, the level of risk if an erroneous result is given if it is software; the fact that they are very specific makes correct application easier and they help us to identify the most suitable class according to the characteristics of the product in question.

Source:

Pharmacopeia of the United Mexican States Medical Device Supplement 5.0, 2023

Health Regulation

Cofepris actions in clinical research

Post author By DANIEL VILLENA
Post date 19 June, 2024

During the current administration, Cofepris has set the objective of promoting clinical research in Mexico.

This subject had not received the necessary attention in the past, and therefore, there is a significant delay in the evaluation and authorization of clinical study protocols that have led to the reduction of clinical research in Mexico as well as the delay of international protocols.

Among the actions that Cofepris has taken to achieve their objective are the following:

1. Launching of the DIGIPRIS platform for Research and Clinical Trials, in December 2023, where users electronically submit clinical studies for evaluation and authorization. The responses to these procedures are also provided electronically through this same portal. With this, Cofepris estimates to reduce the evaluation times by up to 75% and from December 2023 to May 2024, approximately 90 clinical trials have been authorized through this platform.

2. The publication of the draft for PROY-NOM-262-SSA1-2024 Good Clinical Practices. April 24th, 2024. Although it is still a draft, represents a significant progress as it officially implements Good Clinical Practices in Mexico and, above all, it specifies how they will be implemented in clinical research. Because previously they had only been published as guidelines to comply with Good Clinical Practices in research, but a guideline is not the same as a NOM (Mexican Official Norm), that is aligned to ICH and it details what they consist of and how to apply them, in addition to the Publication of the NOM in the DOF (Official Gazette of the Federation) would make its implementation and compliance mandatory for anyone carrying out clinical research in humans in Mexico.

3. In addition, on May 14th, Cofepris published additional measures to optimize and increase transparency in the evaluation process of clinical trials submitted through the DIGIPRIS platform; among which are:

– Recognition of criteria and evaluation results authorized by ethics, research and biosafety committees presented by the applicant.

– Standardization of evaluation criteria for clinical studies, approaching the best clinical research practices established by ICH.

– Optimization of processes in the import permits for health supplies that are required as part of a clinical research, in order to comply with the legal deadlines established for these procedures.

– Publication of the criteria to be assessed in the clinical studies.

With this set of actions, Cofepris demonstrates its determination to increase and attract investments in clinical research in Mexico.

Especially the use of the DIGIPRIS platform has been widely accepted by users and has managed to speed up the evaluation and authorisation of clinical studies, however it is still premature to quantify the impact of this set of actions on the protocols conducted in Mexico. Without a doubt, clinical research is a great area of opportunity for the growth of the country and to progress in access to new therapeutic options and advanced therapies.

Pharmaceuticals

What is the Regulatory Certainty Strategy for Biosimilars?

Post author By DANIEL VILLENA
Post date 8 May, 2024

In February of this year, Cofepris published its Regulatory Certainty Strategy focused on biosimilars with which they want to establish and make transparent the regulatory framework that will be applied in Mexico (which they intend to be aligned with international standards) for manufacturing, evaluation, and authorization of these products.

It is important to note that biosimilars are biotechnological drug products, which are compared against a reference innovative biotechnological drug product. The authorization of biosimilar biotechnological drug products allows for therapeutic alternatives with the same efficacy (as the reference innovator) at a lower cost. The critical point in these drug products is to evaluate the molecular comparability (through specific studies), in order to confirm their similarity with the reference drug product, and at this point the implementation of an accurate and transparent regulatory framework is directed so that the quality, safety and efficacy of biosimilar drug products can be ensured.

Currently, the applicable regulatory framework is unclear, and there is a tendency to over-regulate. With the regulatory certainty strategic plan, what they want to achieve is:

– Encourage the development and manufacturing of biosimilar biotechnological products in Mexico.

– Establish a robust regulatory framework that is aligned with international standards in order to provide regulatory certainty.

– Promote the capacity of the industry through specific regulatory support strategies in the research and production phases of the drug product.

In order to achieve these three aspects, Cofepris establishes a period of 4 years to develop and implement the regulatory framework that allows achieving the objectives established in the regulatory certainty strategy, beginning in 2024.

Among some of the relevant points of this strategy are the following:

– The creation of the Specialized Unit in Biosimilar Biotechnological Drug products, in the second quarter of 2024. This will be an interdisciplinary group that would focus on address in an specialized and efficient way, the evaluation manufacturing, and marketing of biosimilar drug products.

– The creation of the Pharmaceutical Development Committee for Biosimilar and Biotechnological Drug products, starting in the second quarter of 2024. This Committee will promote the generation of guidelines and recommendations that consider aspects of product development and will be responsible for fully evaluating the evidence presented by a biosimilar to determine if it is biocomparable to the corresponding reference drug product and the opinion of this committee will be considered to obtain the Marketing approval of a biosimilar.

– Comprehensive update of the regulatory framework for the handling and recognition of biocomparability studies, through the adoption of WHO guidelines, elimination of the requirement to perform clinical studies in Mexican population, improve recognition mechanisms for biocomparability studies carried out in countries with health authorities recognized by the WHO.

– Update of the Health Supplies Regulation within 2024.

– Comprehensive review of NOM-177-SSA1-2013 in the last quarter of 2025.

– Develop and establish a guideline with clear and differentiated criteria for modifications in the conditions of the Marketing Approval of biosimilars, categorizing them as major, moderate and minor. That is planned for last quarter of 2025.

– Modification of NOM-164-SSA1-2015 Good Manufacturing Practices for Drugs (API) to include a specific section for biological drugs (API) (first half of 2026)

– Update of NOM-059-SSA1-2015 in order to eliminate the section on biological drugs (API) and limit the field of application exclusively to pharmaceutical finished drug products (first half of 2026).

– Restructure the New Molecules Committee, with the purpose to reactivate the Biotechnological Products Evaluation Subcommittee (second quarter of 2025).

It sounds like a comprehensive strategy to promote access to biosimilar and biotechnological drugs in Mexico. Collaboration with chambers, associations, and professional colleges could indeed amplify efforts and streamline implementation. Building synergies can lead to more effective outcomes and wider availability of these important medical alternatives to all Mexican patients.

Pharmaceuticals

What is the CTD and what does its implementation mean?

Post author By DANIEL VILLENA
Post date 22 March, 2024

On December 15th, 2023, Cofepris published on its internet portal the “Guide for entering information for the Registration application of pharmaceutical products”, which specifies the information that must be submitted together with the drug products health registration application (allopathic, vaccines, blood products or biologicals), the characteristics of the information, as well as the order and format in which the information must be presented, all of this in harmonization with the Common Technical Document (CTD).

With the publication of the aforementioned guide, Cofepris formalizes the adoption of the CTD for the dossiers with which a registration of pharmaceutical products is requested in Mexico, and with this continues to advance in the implementation of the ICH guidelines, and in this way, it intends to comply with the commitments acquired upon being accepted as a member of ICH in November 2021.

But now that the CTD format is implemented, we are going to analyze the differences it has in the integration processes of the dossier for the registration of pharmaceutical products:

In reality, Cofepris continues to request the same information as before, it just changes the order in which it is presented:

Module I is administrative and legal information and it is specific by country. For Mexico, it includes the requirements that Cofepris has always requested without any changes, such as: legal documents, formats, endorsement letters, payments, operating notifications, licenses, GMPs, etc.

Module II is the following in the CTD format and corresponds to the summaries of the experts on the topics of quality, clinical and preclinical information; its implementation in Mexico is new and it is now part of the dossier, just as European manufacturers have it (in the case of foreign manufacturers). In the case of national manufacturers, they will have to generate these documents, which had not been requested until now.

Module III is the quality module, it includes the information on the drug, excipients and finished product and has the same structure as the international CTD, so products that are manufactured abroad, this module will be submitted to Cofepris as sent by the manufacturer of the product. In the case of national manufacturers, only the order in which the information is presented changes.

Regarding the information that Cofepris requested that does not correspond to the CTD format and that is not requested in other countries, such as: the batch records of the finished product batches used in stability, certificates of analysis of API and excipients issued by their manufacturers, corresponding specifically to the batches used in the manufacturing process of the batches used in the stability study (also called stability batch traceability); information on medical devices (when applicable), diluents and primary packaging. The authority continues to request it, but now it is presented in the Regional Information section.

Therefore, there were no changes in these requirements, since in many cases it is difficult or impossible for foreign manufacturers to provide traceability information, because in many countries manufacturing information is only kept for 5 years after the manufacturing date or expiration date of the product, depending on the country. So only in the case of new products can they be registered, and in the end the similarity with the CTD will continue to be partial and traceability will continue to be lacking.

Modules IV and V, correspond to preclinical information and clinical information, respectively, the main impact is how the information is organized for generic products and for new molecules. Previously, only general information or studies that specifically supported efficacy and safety were presented at the discretion of the applicant and now the type of studies that must be presented must be specified in detail.

As a perspective, we hope that the implementation of the CTD format will help speed up the resolution of new and pending applications for registration of pharmaceutical products, improving the response times that the Authority has officially established for the processing of registration applications of pharmaceutical products, and finally, the lag is eliminated.

However, Regional Information will now be the name of the new challenge, since in no other country where the CTD is used, traceability is a requirement for the registration of drug products and it is information that can only be obtained for products that have less than 5 years in which the batches of finished product for stability tests have been manufactured.

Medical devices

Do you know what the characteristics of a Free Sale Certificate (FSC) are for the application to request registration of Medical Devices of foreign manufacture?

Post author By DANIEL VILLENA
Post date 28 February, 2024

The Free Sale Certificate (FSC) or Certificado de Libre Venta (CLV) in Spanish, is a document through which the Health Authority of the country of origin, whether the real or legal manufacturer of the medical device to be registered, certifies that the product is authorized and complies with the legal provisions of the country and that it can be sold, used or consumed freely and without any restrictions in the country.

This document is a mandatory requirement for the registration of foreign-made Medical Devices in Mexico.

Main features:

It must be issued by the Ministry of Health of the country of origin of the product.
The document must be current at the time of its presentation. If the document does not contain the expiration or validity date, the document issuance date must not be more than 30 months.
The document must be authenticated, this means that it must be:
- Legalized or endorsed (by a Mexican consul in the country of origin, after notarization) for countries that do not belong to the Hague convention. Or that their agreement with the Hague convention does not allow them to apostille FSCs.
- Notarized and Apostilled for countries that belong to the Hague convention. The Apostille must be issued by the competent authority in each country. (more information at: https://www.hcch.net/es/instruments/conventions/specialized-sections/apostille )
- It is very important that the legalization or apostille is carried out in the same country in which the document is issued.
The document can be presented in Spanish or English, if it is in a different language, translation into Spanish will be required by an expert translator in Mexico, before its presentation to the authority.
The document can be submitted in original or in a copy certified by a notary in Mexico.

What should it include?

Product name (Distinctive name and model)
Legal Manufacturer Data (Company name and address)
Data on the actual manufacturer or manufacturing site, if applicable (company name and address)
List of presentation codes
It must indicate that the product has been authorized in the country of origin of the product for sale and consumption.

Equivalent documents:

1. Letter issued by the Ministry of Health of the country of origin indicating that said products are not subject to health control.

2. Document issued by the corresponding government Ministry, which regulates medical devices in the country of origin, of which evidence must also be presented.

3. If the product does not have a FSC, then reports of clinical studies carried out in Mexico must be submitted, in accordance with applicable Mexican regulations.

Source:

Pharmacopeia of the Mexican United States Medical Device Supplement 5.0, 2023

Secciones

Suscribirse a Newsletter

Contáctanos