Author: DANIEL VILLENA

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

Medical devices

How are Medical Devices grouped in Mexico depending on the category to which they belong?

Post author By DANIEL VILLENA
Post date 15 January, 2024

Modern knee and hip prosthesis made by cad engineer and manufactured by 3d printing

In Mexico there is the possibility of grouping one or more similar products or similar products in the same Sanitary Registration, depending on their indication of use, functionality, physical or pharmaceutical form, manufacturing materials and manufacturing lines.

In the Supplement to the Pharmacopoeia of the United Mexican States for Medical Devices, version 5.0, there is a regulatory appendix that contains a guide to standardize the criteria applicable to Medical Devices in their different categories of Diagnostic Agents, Hygiene Devices, Surgical and healing supplies, Prostheses, Orthoses and functional aids, Medical equipment, Dental supplies and software. In which specific criteria are established for each category of Medical Device, however, before taking into account the criteria that specifically indicate the characteristics of the products, certain general criteria must be considered that allow the products to be categorized appropriately.

When you want to know if the products to be registered can be included in a single registration, the first criteria that must be considered are the following:

General Criteria:

The product must be manufactured by the same manufacturer, whether a subsidiary or a Third party manufacturer.
That the product has the same Commercial name, generic name and indication of use.

Subsequently, if the products meet the criteria above, with the help of the following grouping criteria based on the categories of medical devices, a more specific evaluation is carried out based on their characteristics to then determine if they can be included in a single registration.

✔ Diagnostic agents:

Kit or package of reagents: They can be included in the same registration as long as they are for the same determination or identification of the same analyte, parameter or object of study.
Rapid tests: They can be included in a single registration per physical form of support (test strips, cassettes, pen, among others). Test strips, control and calibrator can be registered as a Kit, as long as they are intended for use with the rapid test only.
Exclusion: lancets, cotton or alcohol wipes, glucometer or self-diagnosis equipment, must be registered separately.
Culture media: Same indication for use, same composition or formula and physical appearance.
Dehydrated, prepared and semi-prepared culture media, in a bottle, tube or plate, that have the same indication of use for the selective medium can be included in the same registration. Supplements of unprepared culture media that are necessary for them to fulfill their indication for use can also be included.
Control materials: They should be grouped by diagnostic specialties.

✔ Hygiene Products: Products that only differ in the following components of their formula can be included in a single registration: Colorant, flavoring, or perfume; and that they retain their general physicochemical characteristics (e.g. pH, density, viscosity, stability, etc.). As many presentations as requested can be authorized as long as it is the same supply, only the size or weight changes, but not the formulation or indication for use.

✔ Surgical and healing material, Prostheses, Orthoses and functional aids

Same type of product with its presentations and models: as long as they are made of the same materials, manufacturing, formulation or composition, indication of use and distinctive name.
System: Supplies that are packaged together or not, that are for exclusive use among themselves, intended to be interconnected or combined with the purpose of achieving a specific indication of use, can be registered in this way.

✔ Medical equipment

Medical equipment with components and accessories: All that is necessary for the performance and function of the medical equipment can be registered in a single Sanitary Registration.
Different models, presentations or sizes can be included as long as they have the same technology or indication for use.
Medical instruments: Same indication for use, technique, surgical procedure, field of application or purpose of use.
A type of instrument can be registered with its different presentations or models as long as it is made of the same material and has the same indication of use.
System: The instruments required for the placement of a specific prosthesis may be registered as a system as long as they are intended for the same indication of use or surgical technique.

✔ Supplies for dental use: Intended for the same indication of use or dental surgical procedure, same manufacturing material.

For formulas: You can add as many as you want as long as the active principle or ingredient does not change.
Systems: Same dental surgical procedure, or its presence in the system is otherwise justified.

✔ Software: this is a new category and there are still no specific criteria for this type of product, for the moment only the general criteria would apply.

Note: Presentations intended for distribution in different commercial chains can be included in the same registration, as long as the same Commercial name is maintained.

Each product individually must comply with the guidelines established by the Secretary of Health to obtain the Sanitary Registration of Medical Devices and as always, the final criterion when granting the registration will be that of the Reviewer.

Source:

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

Pharmaceuticals

Vitamin Drug Products Regulation

Post author By DANIEL VILLENA
Post date 27 November, 2023

Vitamin drug products contain only vitamins or minerals, alone or in combination , that are meant to prevent or treat conditions caused by deficiencies or insufficiencies of them. Because they are drug products, they must have a Registration (Marketing Authorisation) granted by Cofepris so that they can be marketed. The Holder must also have a Certificate of Good Manufacturing Practices either in Mexico or in the country of origin abroad, like any other pharmaceutical product.

The Regulation for Health Supplies (RIS) establishes the daily doses of vitamins and minerals that determine the classification of the drug product, that is, so that they can be marketed without a medical prescription, and then they are classified as fraction V or VI (OTC) or those that exceed the doses established in the RIS, as well as those administered parenterally, will be classified as fraction IV and will require a medical prescription to be dispensed.

Since these are pharmaceutical products, safety, effectiveness and quality of the product must be verified in order for it to be authorised for marketing (registered). Therefore, all technical, quality and legal information related to the product must be submitted with a registration application for pharmaceutical products.

It is important to mention that a vitamin pharmaceutical product is not the same as a food supplement, the latter is classified as a product, within the classification of Products and Services, and a vitamin/minerals product is a pharmaceutical product. Food supplements do not require letter registration for their marketing and their function is only to complement the daily intake of vitamins and/or minerals in the diet, they do not have any therapeutic function, they are regulated in the Regulation of Health Control of Products and Services. (RCSPS) and cannot contain only vitamins and minerals, but must contain a combination with other substances such as carbohydrates, proteins, amino acids, fatty acids, metabolites, plants, herbs, algae, dehydrated or other foods. The RCSPS is also i charge of establishing the daily intake limits of vitamins and minerals allowed for Food Supplements.

If you have any questions about your product, we are experts in the classification, labelling and compliance of requirements of both Vitamin pharmaceutical Products and Food Supplements, so please contact us.

Pharmacovigilance

Differences between the 2012 and 2021 version of NOM-241-SSA1.

Post author By DANIEL VILLENA
Post date 10 July, 2023

Official Mexican Norm NOM-241-SSA1

Good Manufacturing Practices for Medical Devices.

On December 20, 2021, the Ministry of Health published, in the Official Gazette of the Federation, the update of Official Mexican ORM NOM-241-SSA1-2021, Good manufacturing practices for medical devices, which aims to establish the minimum requirements for the processes of design, development, manufacturing, storage and distribution of medical devices so that they are used by the patient or final consumer.

This new standard replaces its previous version (NOM241-SSA1-2012), which became obsolete as of June 20, 2023.

This article will describe generally the overall main changes in this new version that, as described below, have a high impact for the industry:

– Changes were made to the wording, which facilitated understanding and avoid the ambiguity of some definitions and requirements.

– Terms, abbreviations and definitions were incorporated such as: GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GSDP (Good Storage and Distribution Practices), GLP (Good Laboratory Practices), Certificate of Conformity, Software as medical device.

In this update we can observe as a point of improvement, that some particular requirements that were dispersed in the body of the standard were broken down and grouped together. For example, there is already a chapter on quality risk management, since the previous standard addressed risk management, but in numerals that were found throughout the standard, and now they are found jointly in the section quality risk management.

Likewise, there are specific chapters on Documentation, out of specifications handling (non-conforming), returns and complaints, change control, deviations and technical audits.

Some concepts were harmonised with other Official Mexican Standards for Good Manufacturing Practices, as well as with other international guides and standards. For example: the modification of the definition of medical device where the Software is already included as a medical device, you can check on our blog, what we wrote about it. https://bit.ly/3Tmfr4r

One of the most evident changes of this standard is the requirement to carry out Quality Risk Management, which must be aligned with ISO 14971, FEUM and quality tools must be used to carry out this risk management. It must also be documented in SOPs, and as a requirement, personnel must be trained with said SOPs. In addition, the personnel that carry out risk management must be qualified to be able to implement it. With this new version, risk management must be implemented for systems, operations and processes.

Other of the most relevant modifications refers to the staff. Previously, there was a legal blank space in the General Health Law, since it included the professions that a SANITARY responsible (SR) of various establishments should have, except to be SR of medical device factories.

In this new version, this gap is covered with what is indicated in numeral 9.1.2.1, where it indicates that to be an SR you must have a minimum degree in the pharmaceutical, chemical, biological, of medicine, biomedical, biochemical or other professional field, as long as it is related to the process.

A new numeral that appears in the chapter is the delegation of functions, where the SR is empowered to delegate an assistant in writing, where it should be noted that it delegates functions but not responsibilities.

There is also a number referring to the requirements of Good Storage and Distribution Practices, which applies to independent warehouses that do not belong to a medical device factory, such as distributors.

The standard in its previous version spoke of having to carry out a quality management system where the quality management system must be implemented, documented and maintained, as well as maintaining its effectiveness in accordance with the requirements of this standard established in a quality manual. This new version describes in more detail each of the processes that must be carried out by identifying the process needs for the GMP system.

In this version the field of application was extended. It is no longer limited to medical device processes, but also explains other types of processes such as manufacturing, storage, conditioning, warehousing, and distribution.

A great challenge is the regulation of Good Storage and Distribution Practices since in Mexico we have a large number of establishments and out of the products on the market that they sell, they are only dedicated to the importation of medical devices and their distribution.

Due to the great growth of the Medical Devices industry, particular requirements have had to arise that include the full range of medical devices for compliance with GMP in different applications and processes, which we consider to be a great achievement to be able to detail and be clearer in terms of regulation and clarity always facilitates compliance.

Bibliography: NOM-241-SSA1-2021, Good manufacturing practices for medical devices. DOF: December 20, 2021.

Pharmaceuticals

Regulation of herbal medicines and herbal remedies

Post author By DANIEL VILLENA
Post date 5 July, 2023

Mexico is a country where it is culturally very common to use various plants to alleviate symptoms, or for the treatment of some diseases. These products are made out from plants or derivatives, and it is important to identify the two different types of these products and to understand how they are regulated.

Mexico includes in their regulation: herbal medicines and herbal remedies. It should be noted that these products are different even though both are made from vegetable materials or derivatives. Both kinds of products are subject to evaluation and marketing authorization prior to their commercialization by our Ministry of Health that is Cofepris.

Herbal medicines:

The General Health Law establishes in article 224 B section III that herbal medicines are: products made of plant material or some derivatives, which main ingredient is the aerial or underground part of a plant or extracts and tinctures, as well as juices, resins, fatty and essential oils, presented in pharmaceutical dosage form, which therapeutic efficacy and safety have been scientifically confirmed in the national or international literature.

Herbal medicines should not be combined with isolated and chemically defined active principles, nor should be injectable products.

The formulation of an herbal medicine cannot include narcotic or psychotropic substances of synthetic origin, nor mixtures with the allopathic medicines: procaine, ephedrine, yohimbine, chaparral, germanium, animal or human hormones or other substances that contain hormonal or anti hormonal activity.

Just manufacturing companies within or outside Mexican Territory with a manufacturing GMP certificate issued by a Health Authority can be the holders of the registration (marketing authorization) in Mexico. If the manufacturing company is abroad, they would need a Mexican counterpart company that acts as a Legal Representative and is in charge of the application to the registration and has the infrastructure required to hold the regulatory responsibility of the products and will be the only one authorized for importing the products to Mexico.

Herbal medicines are subject to marketing authorization prior to their launching, which once granted will be valid for 5 years and can be renewed.

Herbal medicines are considered as OTC (over the counter), so a medical prescription is not required for their sale in pharmacies. The labeling of these products must comply with the Mexican norm NOM-072-SSA1-2012: Labeling for pharmaceuticals, herbal medicines, and remedies.

Herbal remedies

Article 88 of the Regulation for Health Supplies (RIS), establishes that a Herbal Remedy is considered to be the preparation of medicinal plants, or their parts, individual or combined, and their derivatives, presented in pharmaceutical dosage form, which therapeutic activity for the relief for some or isolated symptoms of a are known and referenced by popular or traditional knowledge.

Herbal Remedies, as well as Herbal Medicines, must not contain in their formulation narcotic or psychotropic substances or any other type of allopathic drug or other substances that generate hormonal or anti hormonal activity.

Herbal remedies are subject to authorization from Cofepris for their commercialization, through the issuance of a Permit for herbal remedies, which contains an alphanumeric code assigned to each product. It should be noted that this Permit is not the same as a Registration Letter. However, both are considered marketing authorizations.

The permit has not an expiry date and cannot be modified, if any change is required a new application must be considered.

The Mexican manufacture of herbal remedies must follow NOM-248-SSA1-2011 Good Manufacturing Practices for establishments dedicated to the manufacture of herbal remedies. Foreign manufacturers are requesting Pharmaceutical GMPs for manufacturing.

As the Marketing authorization is not a registration, herbal remedies do not follow the rules for holding pharmaceutical products, and the importer, as long as they have a notification in Cofepris and a warehouse, can be the permit holder and the distributor.

Herbal Remedies are also considered OTC products, and their sale does not require a prescription.

In both cases, for application of the marketing authorization, a dossier must be fulfilled and submitted, including legal documents: GMP Certificate, Free sale certificate, representation letter or power of attorney and technical information that support the quality, safety, and efficacy of the products plus a taxonomic identification certificate for each of the plants used.

As mentioned, the main difference between both kinds of products is in the information to be used to provide the efficacy evidence. For herbal medicines: reports and papers of clinical studies and clinical evidence. And for herbal remedies: literature information or monographs, testimonies, etc. confirming the traditional use of a plant for the relief of the symptoms that are claimed.

Therefore, the difference between a herbal remedy and an herbal medicine is that the first one is only intended for symptom relief not necessarily related to a disease, and not as part of the therapeutic scheme or treatment. And for an herbal medicine, it has an identified therapeutic effect and efficacy for the symptoms associated with a given disease and can be part of the therapeutic scheme, and it is regulated by the pharmaceutical’s regulation.

Based on the aforementioned information, regarding the advertising, Herbal Remedies should only be claimed for the symptomatic effect and not as therapeutic and Herbal medicines can include the therapeutic indication that is authorized in the MA. Both classes of products require advertising permissions prior to the diffusion of the advertising campaign.

In Raf Consulting we have an expertise in obtaining MA for Herbal medicines and remedies, and would be glad to help you to meet your marketing goals in Mexico.

Medical devices

Supplement to the Pharmacopeia of the United Mexican States for Medical Devices (MD)

Post author By DANIEL VILLENA
Post date 3 July, 2023

The Pharmacopoeia of the United Mexican States is the regulatory document for health supplies established in the General Health Law and issued by the Ministry of Health, which helps to guarantee public health by consigning:

• Methods of analysis and reference substances

• Requirements on the specifications of identity, purity and quality of inputs for health and their raw materials.

Mexico is the only country that has a supplement to the Pharmacopoeia specialised in Medical Devices, which was published for the first time in 2006. Currently the prevailing edition is the 4th, and it was published in 2017.

What is it?

The supplement is a specialised book, which is constantly updated, where the rules are described, through monographs and analysis methods, that a Medical Device must comply with to demonstrate its indication for use. That is, to demonstrate that a product can diagnose, prevent, watch or monitor, or that it will function as an aid in the treatment of diseases as long as it is not through pharmacological, immunological or metabolic mechanisms, and its safety is demonstrated through clinical studies.

This compendium is mandatory and has the same regulatory value as an Official Mexican Standard, and the Secretary of Health monitors its compliance through the Federal Commission for Protection against Sanitary Risks (COFEPRIS).

How is it composed?

Content

• GeneralitiesChapter – Contains instructions on how to consult the supplement, some instructions to consult the general methods, explains the different devices it contains, the general interpretations that you must take into account when reading a monograph.

• Chapter on Solutions and reagents – Explains the preparation of 333 reagent solutions, volumetric solutions, buffer solutions, indicator solutions and indicator papers, which will be used in the different chemical determinations.

• General Methods of Analysis Chapter – Contains 65 described methods. These methods appear individually in this chapter when they apply to more than two monographs, otherwise the specific method is included within the device monograph

This chapter contains general methods (MGA) which are shared methods with medicine, that means they can apply to both Medical Devices and drug products; and specific methods that only apply to MGA-MD Medical Devices. These methods are based on bibliography, norms or reference standards or specifications that verify the effectiveness of products, in order to establish safe methods that guarantee each batch that is manufactured with the required quality.

• Medical Device Monographs Chapter – Contains 224 monographs in alphabetical order, some are product-specific (eg oxygen concentrators), but some are general, such as sutures, as it applies to an entire family of products. Through a monograph the largest number of Medical Devices is brought together because the world of these supplies is very wide and variable, and it is a great challenge to include and customise them.

They vary according to the category of the MD, but in general terms they must contain the following:

o Title

o Product designation – Name or generic description given to the product based on its characteristics.

o Description.

o Finish – Indicates the product characteristics of the finished product and generally includes requirements that, together with functionality tests, determine whether the medical device is suitable for use.

o Identity of the manufacturing material.

o Limits- Based on analytical practice. Prescribed to determine if the substance under examination meets the requirements of the monograph.

o Marking and labeling.

o Figures – Diagrams that allow easier identification of the medical device.

• Radiopharmaceutical Monographs Chapter: Contains 224 monographs for this type of products.

• Appendices- Contains the following 10 appendices:

o Sanitary regulation applicable to MD.

o Criteria for MD classification.

o Guidelines for obtaining the sanitary registration.

o MD grouping criteria for health registration purposes.

o Application of MD risk management.

o Conservation and management of reference microbial cultures.

o Microbiological analysis of non-sterile products.

or Glossary.

o Technovigilance activities.

o Biocompatibility. A table for the selection of tests harmonised with ISO 10993 is included.

Source: Pharmacopoeia of the United Mexican States, Medical Devices Supplement, 4th Edition, 2017.

Facilities

Technovigilance Report

Post author By DANIEL VILLENA
Post date 3 July, 2023

Technovigilance is in charge of monitoring the safety of Medical Devices and this, in turn, is a set of activities where all the information related to the risks of any verified event related to the use of a medical device is evaluated and identified (through conclusive evidence), and that could be caused by a malfunction or alteration of the characteristics of the Medical Device (MD) and that could cause the death or serious deterioration of the health of the user. This is carried out through notification, to identify the frequency and severity of adverse incidents in order to prevent them, and if they exist, reduce them.

One of the main activities through which our health authorities (COFEPRIS) monitor the safety of Medical Devices in Mexico is through the Technovigilance Report, which is a document that includes all the safety information that has been compiled in the last 5 years of the medical device in question and that is presented before the CEMAR (Evidence and Risk Management Commission) particularly before the Executive Directorate of Pharmacopoeia and Pharmacovigilance, and is a requirement for the process of renewal or extension of a Sanitary Registration. In addition, it is included in the Technovigilance installation and operation standard.

In accordance with our regulation, the holder of the Sanitary Registration domiciled in Mexico is the one who must present the Technovigilance report, as indicated in NOM-240-SSA1-2012, Installation and operation of Technovigilance, at least 240 calendar days before the expiration date of the Sanitary Registration. In the case of a first extension request, the period covered is a minimum of 4 years; after the first extension the period will be 5 years.

The Technovigilance report is made up of the following:

1. Cover: Data of the MD and data of the holder according to the Sanitary Registration, data of the Sanitary Responsible, period covered by the ITV and date of preparation.

2. Monograph: All the information corresponding to the MD such as: Generic and distinctive name, type of input and classification of the MD (according to the Mexican regulation), information on the manufacturer, distributor and importer, indications for use, precautions, contraindications, presentations (only the models/codes/references that have been marketed during the ITV period), Serial number, batches or presentations that have been presented, adverse incidents, corrective, preventive and corrective field safety actions in the national territory and software version .

3. Safety data sheet in Mexico: General data from the MD, time spent in the national market (years and months), number of units marketed in Mexico per year, total units marketed during the ITV period, data that can help to estimate the number of patients exposed (calculation method), total number of reported adverse events, total number of reported serious adverse events, and total number and description of unforeseen adverse events.

4. Annexes: Copy of the Sanitary Registration, Copy of the Official Letter of registration of the Technovigilance unit and person responsible for the ITV, insert or equivalent, security sheet (as applicable for the type of MD).

The above information must be submitted to the aforementioned regulatory entity, through the COFEPRIS Comprehensive Services Center, in writing.

On April 25th, the Executive Directorate of Pharmacopoeia and Pharmacovigilance issued an official letter indicating that as of June 2023 the ITV must be submitted electronically either on a USB memory or CD containing: the monograph, safety sheet in Mexico and annexes. Each document must be as a separate file in PDF format. Only the cover and a simple copy of the Sanitary Registration must be presented in print.

*Source: Official Mexican STANDARD NOM-240-SSA1-2012, Installation and operation of Technovigilance.

Health Regulation

Regulatory certainty strategy for the pharmaceutical sector

Post author By DANIEL VILLENA
Post date 3 July, 2023

Healthcare Legistation text with document brown envelope and stethoscope isolated on office desk.

At the end of last January 2023, Cofepris published on its website and on social networks its Regulatory Certainty Strategy for the pharmaceutical sector, in which they establish 7 commitments with which they want to comply with the regulatory framework, provide clarity and certainty to the user about requirements, processes and evaluation times, and also comply with the commitments acquired by Cofepris as a regulatory member of ICH (International Conference of Harmonization).

The commitments are the following:

1. Installation of a Committee of Good Regulatory Practices. It is intended that all changes in the regulatory framework be coherent and viable, always taking regulatory improvement into account. The Committee will have participation from the public, private and social sectors. Lastly, they plan to have thematic sessions with the regulated sectors involved and the technical teams of Cofepris.

2. Authorization of drug products by recognition. The objective is to establish the criteria and guidelines for reliance procedures.

3. Regulatory harmonization. Its purpose is to comply with the commitments acquired by Cofepris, as a member of ICH. They plan the adoption of various ICH guidelines and the creation of a Standard in Good Clinical Practices, in different periods of time.

4. Digitization as a way of optimization. Implement digital solutions in order to optimize the evaluation of pharmaceutical procedures, reduce the backlog and meet legal deadlines in the evaluation of pharmaceutical products. For example, they are working on developing a platform for processing minor and moderate Modifications to the Registration Conditions, in which an automatic resolution can be obtained.

5. Bioequivalence and biocompatibility studies. The objective is to allow the recognition of bioequivalence and biocomparability studies carried out abroad. They are working on the issuance of a new NOM-177 that establishes the guidelines for the recognition of these studies, in record times.

6. Safe use of Active Pharmaceutical Ingredients (APIs). They intend to generate and publish criteria and guidelines that allow the entry and supply of low-risk APIs manufactured in countries that do not have GMPs or an equivalent document, issued by High Surveillance Regulatory Agencies such as China, India, Pakistan, etc. as long as they comply with the provisions of ICH, PIC/s, etc. This is not intended to deregulate, but to optimize and strengthen health surveillance.

7. Entry of foreign-manufactured biotechnological drugs. The objective is to reduce trade barriers with an impact on the supply of biotechnological medicines in Mexico. It is worth mentioning that vaccines are not contemplated at this point, they will continue being released as before.

Cofepris plans to develop and implement these 7 commitments in a period from the fourth quarter of 2022 to the fourth quarter of 2030.

For all the commitments, it is intended to start their implementation in the first quarter of 2023, with the exception of Regulatory Harmonization, which is planned for the fourth quarter of 2026. With this, it is intended to comply with the international commitments acquired in free trade agreements (TMEC, Pacific Alliance), as well as those acquired with the WHO, ICH and PIC/s.

Since 2022, the digitization of procedures such as Notices of operation and health manager, Request for renewals of registration letters(first and second or subsequent), advertising notices began and this has allowed greater efficiency of the CIS. We hope that in the near future, it will also have an impact on the opinion areas and we can see a greater influx of procedures available with resolution in the CIS, which until now has not increased.

The seven commitments are very ambitious and although they will be presented in the long term, their implementation and operation will simplify many regulatory procedures related to medicines, both for the industry as a user and for Cofepris as the Regulatory Agency, hopefully in the short term.

And above all, they will improve the evaluation of various procedures, generating greater certainty in terms of the times and criteria for evaluation and resolution, which will combat a major problem that Cofepris currently presents, which is the lag in the resolution of procedures. And we are waiting for the Regulatory Certainty Strategy applicable to medical devices, because it is also very important, since it covers a majority of the health supplies that are required for proper patient care and access to new technologies.

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