Mexico

Cooperation on pharmaceuticals with France

On July 11, the Health Agencies of Mexico (COFEPRIS) and France (ANSM) signed a Collaboration Agreement on pharmaceuticals, vaccines as well as medical and cosmetic devices with the aim of exchanging regulatory information and experiences that facilitate access of patients to safe, efficient and high-quality products.

According to the Federal Commissioner of COFEPRIS Mikel Arrióla, this agreement will be in force for three years. He added that both agencies plan to strengthen their communication regarding healthcare consumables in order to improve the protection of patients.

This initiative stems from the need to harmonize Mexican health regulations with international best practices and is supported by the Framework Health Agreement signed between the Mexican and French governments on March 9, 2009 in Ciudad de Mexico.

Source: http://www.cofepris.gob.mx

Mexican universities and research centers authorized as third parties to test biotech drugs

In an unprecedented move, the Mexican Health Authority (COFEPRIS) has authorized a university and two research centers as third parties to perform the characterization tests and preclinical studies needed to demonstrate the biosimilarity of biotech drugs submitted to COFEPRIS.

In order to formalize this alliance, COFEPRIS has signed cooperation agreements with the National Autonomous University of Mexico (UNAM), the National Polytechnic Institute (IPN) and the Center for Research and Assistance in Technology and Design of the State of Jalisco (CIATEJ).

The inclusion of these institutions to the model of authorized third parties will allow the pharmaceutical industry to ask for scientific-technical support regarding the tests requested by COFEPRIS during the biotech drugs authorization process.

This decision has been made within the framework of the “Strategy for the implementation of the regulation of biotech drugs in Mexico,” that resulted in the publication of Regulation 257, which entered into force in February 2015, as reported here.

COFEPRIS informed that biotech drugs currently represent between 10 and 15 percent of the national pharma market, and it is estimated to increase to 45 percent in 2016.

Source: http://www.cofepris.gob.mx

Cooperation between Health Authorities of Mexico and UK

With the aim of improving public health and facilitating the import/export of drugs and medical devices, Health Authorities of Mexico (COFEPRIS) and the United Kingdom (MHRA) recently signed a Cooperation Agreement.

The “Exchange of Information Agreement,” which was signed during the official visit of the Mexican President Enrique Peña Nieto to London, is derived from a memorandum of understanding on the subject of health signed between both countries.

The cooperation activities covered by the agreement comprise the exchange of information, documents and experiences regarding drugs, medical devices and other health consumables. Topics include pharmacovigilance, safety and quality of products, health authorization and inspection reports.

According to COFEPRIS, this agreement will benefit both the public health, since it will improve the access of Mexican people to innovative medical products, and the Mexican government, as it will strengthen its regulatory framework.

Mikel Arriola, head of COFEPRIS, noted that this is the second health agreement between Mexico and a European country signed in 2015. The first was with Poland.

Source: http://www.cofepris.gob.mx

New generic drugs will be approved by Mexican Authorities

In the upcoming months, the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) will approve 28 new generic drugs that are usually used in the treatment of diseases related to inflammation and pain.

This is a new step forward for the Mexican government in its effort to give easy access to low-cost drugs to local patients.

According to the local Sanitary Authority, 107 generic drugs were approved in 2014. The approval of this category of drugs has helped decrease their price by 61 percent.

Source: http://www.cofepris.gob.mx

Deregulated 573 Medical Devices

The Mexican Health Ministry, through its Federal Commission for the Protection against Sanitary Risk (COFEPRIS),  recently published a list containing both health consumables regarded to be of low risk and 573 reclassified products that are no longer considered to be health consumables and do not require a health registration to be marketed in Mexico.

Deregulated products comprise diagnosis agents, hygienic products, first aid products and dental consumables, among others.

This recent reclassification follows a 2011 reclassification when COFEPRIS published the first list of 1,669 reclassified non-medical devices and 96 low-risk medical devices.

Click here to access this recently published list, which currently comprises 2,242 products and consumables.

Source: http://www.cofepris.gob.mx

Transitional period planned for Regulation 257 on biotech drugs

Regulation 257 on biotechnology and biosimilar drugs, approved recently by the Mexican Health Authority (COFEPRIS), will enter into force in early February 2015. This regulation establishes a transitional plan for the renewal of health registrations of biotech drugs that were granted before the changes to the Regulations of Health Supplies, which were published in 2011, entered into force.

The transitional plan establishes that:

• COFEPRIS will classify the corresponding product as innovative or biosimilar.
• Renewal applications of innovative biotech drugs will not require the opinion of the Subcommittee on Evaluation of Biotechnology Products (SEPB).
• Renewal applications of biosimilar drugs require an opinion by SEPB stating the reference product so that applicants can carry out the corresponding studies.

This plan will apply to all renewal applications received before December 31, 2015.

 
Source: http://www.cofepris.gob.mx

Boosting access to biotech drugs

In December 2014 the Mexican Ministry of Health completed the regulatory framework for the registry of innovative biotechnology and biosimilar drugs, which are used for the treatment of chronic degenerative diseases such as cancer, diabetes, hypertension, asthma and arthritis.

Regulation 257, which will enter into force in early February 2015, establishes the guidelines, requirements and criteria that the Mexican Health Authority (COFEPRIS) will apply for the evaluation, approval and renewal of innovative biotechnology and biosimilar drugs.

In addition this regulation defines the criteria that COFEPRIS will apply during the registration process of the biotech drugs, the requirements for manufacturing process control, the procedure for the authorization of clinical trials and the specifications for the establishment of reference drugs.

Before applicants can submit their dossier to COFEPRIS for registration the New Molecule Committee and the Subcommittee on Evaluation of Biotechnology Products must review the available information and issue a report on whether there are technical data to prove the safety, quality and efficiency of the new biotech drug.

This new regulation encourages the registration of new biotech drugs, which already represent 35% of applications received by COFEPRIS.

Source: http://www.cofepris.gob.mx

China recognizes Tequila

As a result of ongoing work between the Mexican and Chinese PTOs, the  world famous  Mexican beverage known as “Tequila” has been recognized as a Denomination of Origin (D.O.) origin China.

In May 2013, legal representatives of the Tequila Regulatory Board (Consejo Regulador del Tequila – also known as “CRT”) in Asia requested the protection provided by D.O. status for Tequila before the authorities of AQSIQ. AQSIQ is a administrative department of the People’s Republic of China in charge of administrative law-enforcement.

More than one year of hard work by staff of several Mexican government entities  helped AQSIQ to recognize and protect Tequila as a D.O. China join , 47 other countries in considering Tequila a D.O.

Source:  http://www.impi.gob.mx

Fast-Tracking for Medical Devices slashes the registration process from years to days

The Mexican Health Authority (COFEPRIS) reports that more than 30,000 medical devices have been registered through the fast-track option during the last two years. This is approximately 25% of the national market, and it includes photopheresis equipment, defibrillators, needleless drug injectors, cataract surgery equipment, X-Ray digitizers and drug testing reagents. Before fast-tracking, it took several years for the newest devices manufactured in other countries to be registered in Mexico. Through the fast-track option, the process takes about 30 working days.

This registration option was implemented by COFEPRIS in 2010 by means of equivalence agreements allowing products already cleared and commercialized for sale by the world’s leading medical device approval authorities – the U.S. Food and Drug Administration (FDA), Canada’s Health Canada (HC) or Japan´s Pharmaceuticals and Medical Devices Agency (PMDA) – to be sold in Mexico without meeting any additional substantial regulatory requirements.

Approximately 64% of the applications received by COFEPRIS are for the import of medical devices from the U.S., 33% from Canada and 3% from Japan.

Source: http://www.cofepris.gob.mx

Mexico and U.S. sign a statement of intent to ensure the safety of food products

The Mexican National Service for Agro alimentary Public Health, Safety and Quality (COFEPRIS), the Federal Commission for the Protection from Sanitary Risks (SENASICA) and the U.S. Food and Drug Administration (FDA) have signed a statement of intent to cooperate in the promotion of the safety of fresh and minimally processed agricultural products.

This strategic partnership will focus on finding practices to prevent contamination during the growing, harvesting, packing, manufacturing, processing, holding and transportation of fresh fruits and vegetables and identifying verification measures to ensure these preventive practices are being effective.

The aim of this document is to reduce the risk of illnesses and deaths associated with the intake of fresh and minimally processed agricultural products in both countries. With this purpose, each country’s agencies will work together to ensure industry compliance with produce safety standards.

Source: http://www.cofepris.gob.mx