Day: July 3, 2023

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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