The international standards for risk management iso 14971 and biocompatibility iso 10993 are accepted 11. Medicinal product regulation and product liability in mexico. The good manufacturing practices gmp certificate of the manufacturer. Cofepris is an agency with broad regulatory powers, which main activity is the prevention against sanitary risks. Good manufacturing practices guide for drug products. In october 20, the mexican health authority released a new document setting the criteria that will be used to accept gmp certificates as valid. Gmp inspections by cofepris regulatory affairs in latin. This criteria applies to certificates of manufacturing facilities both of finished products and api. For new registration or renewal of drug products or drug substances of any kind manufactured in countries not considered as high sanitary surveillance by cofepris. In the united states, current good manufacturing practices, or cgmps, are the fdas formal regulations contained in statutes and agency policies and concern the design, monitoring and control of manufacturing processes and facilities. Aug 19, 2014 mexicos medical device regulations accept iso certifications, and dont seem to have specific good manufacturing practices requirements that may slow down the registration process.
Canadian gmp guideline and canadian companies exporting drugsmedicinal products to any ec member states that fall within the scope of the mra and that are manufactured within canada may benefit from specified gmp exemptions provided by the mra. Good manufacturing practice gmp is the minimum standard that a medicines manufacturer must meet in their production processes. Based on health risks, cofepris determines if food and food products imported into mexico. For all food manufacturers this is a must study topic. Enroute, foreign manufacturers might face challenges. Under the health law regulations and noms, cofepriss. Gmp iso 22716 and cosmetics regulation ec no 12232009. Mexico at the vanguard late 90s 1997 1998 2004 2005 some legal modification of inclusion of some usa eu started eu. Latin american countries regulatory requirements overview. Brazil is a member of mercosur and many of the laws are harmonized with the mercosur directives. The following regulation impact the medical equipment and medical devices industry.
Mexicos regulatory process for medical devices mexico. Good manufacturing practices for medicinal products nom059ssa12015. The standards of good manufacturing practice gmp applicable to this manufacturing plant are at least equivalent to those laid down in the eu gmp of whoich q7. Jun 25, 2019 in the united states, current good manufacturing practices, or cgmps, are the fdas formal regulations contained in statutes and agency policies and concern the design, monitoring and control of manufacturing processes and facilities. The 2020 pics seminar on how to be a good gmp inspector in 2020 will be taking place in bangkok thailand on. But, as alejandro luna, agustin azcatl and ingrid ortiz of olivares explain, there are still some areas that need to be addressed i n june 2009 biologics were included in the mexican. Some devices of class i are exempt from gmp requirements 4. Navigating differences between fda and emea for regulatory.
Regulatory affairs in emerging markets prague, october 20 2. We also can help you register your medical devices with cofepris in mexico. Food laws and regulations in mexico fda compliance. Cofepris regulates the following industries and business process. Labeling of medical devices united mexican states ministry of health. Cofepris to accept the be study performed in india against mexico reference product. The information on this page is current as of april 1 2019 for the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the. Dec 09, 2019 the regulatory agency that promotes gmp in canada is health canada hc through the good manufacturing practices guide for drug products gui0001, 2018.
The following guideline can be ordered through the address listed in the sourcepublishercategory. If you do, you must make sure that you comply with these. To follow are five common causes of confusion that tend to occur in interpreting these regulations and good manufacturing practices. Eu gmp guidelines for human and veterinary medicinal products. These laws and regulations are evolving and are not transparent.
Cofepris is a decentralized entity of the ministry of health with. Pdf, 185kb, 3 pages on the use of stand alone contract. Good manufacturing practices, en es, nom 241 ss a12012, 112012. Regulatory update manufacturing quality mexicos cofepris. European union the european medicines agency emea is a decentralized body of the european union. Chapter 57 what are good manufacturing practice gmp guidelines. The chart shown illustrates the cofepris approval process in mexico and is available for download in pdf format. Latest developments in biologic and biosimilar regulation mexico has over several years clarified the ip rules that apply to biotechnology products. Gmp inspections by cofepris regulatory affairs in latin america.
New mexican regulations for food products are the result of the so called crusade against overweight and obesity established by the current government. Cpp who gmp manufacturing license free sale certificate letter of authorization power of attorney. Qs regs for device good manufacturing practices fda. Mexico food and agricultural import regulations and. The dietary supplement health and education act passed in 1994. For new registration and manufacturing changes of biologic, biotech and hemoderivate products. Latest developments in biologic and biosimilar regulation. This translation may not be reproduced online or in any other format without written permission from emergo group. Mutual recognition agreements mras information on mutual recognition agreements between eu and noneu countries. Gmp verification is required by cofepris in the following cases. Mx2052 mexico approves additives for food and beverages page 2 general information. Iran ifda, turkey tmmda and mexico cofepris will become the 50th, 51st and 52nd.
Gmpregulatory environment in the latin americalatin america. This law also covers good manufacturing practices gmp applicable for. Jul 23, 2012 mx2052 mexico approves additives for food and beverages page 3 annex x. Disclaimer for educational purposes, some tables and graphs have been borrowed from an informative cofepris presentation. Health care expenditure is increasing considerably medical device imports is key for regions development exports are very low. The wg gmp proposed a plan for guideline validation, to the steering committee of the panamerican network for drug regulatory harmonization, which was approved and was developed in two parts. All the projects of technical regulations that impact on international trade, even if those regulations are identical to international standards, are notified to wto. Importance of quality risk management in pharmaceutical quality systems.
In addition to drug products, the cofepris is in charge of food and beverages, tobacco products, other healthcare. Pharma regulatory affairs in mexico maria ines guaia informa conference. Gmp certificate for manufacturing site of finished product. Although, this is the case, however, there is some confusion as to what mexicos requirements and regulations are for.
Regulatory collaboration world health organization. Part of the health products and food branch inspectorate inspectorate program is to. We would like to recommend tying in the imp gmp guidance as much as possible into the existing gmp guidance eudralex vol. Iran ifda, turkey tmmda and mexico cofepris accede to pics. Fda has determined that certain types of medical devices are exempt from gmp requirements. Cofepris and good manufacturing practices certificates. Cofepris requires that both domestic and foreign producers of medical devices have good manufacturing practices certificates reduce production costs 50% or more if are you considering setting up manufacturing in mexico fill out the form or call 9155344252.
Using practical examples and comparisons to everyday life will help to easily understand gmp regulations. Canadian pharmaceutical gmp parenteral drug association. A guide for importing medical equipment into brazil. The brazilian health regulatory agency anvisa is an autarchy linked to the ministry of health, part of the brazilian national health system sus as the coordinator of the brazilian health regulatory system snvs, present throughout the national territory. Part of the health products and food branch inspectorate inspectorate program is to conduct inspections of establishments that are.
This report summarizes an announcement by the secretariat of health ss published in mexicos diario oficial federal register on july 16, 2012, on additives and other substances approved for use in food, beverages and dietary supplements. Based on health risks cofepris determines if food and food products imported into mexico should be subject to an import permit previous to importation. Pharma regulatory affairs in mexico linkedin slideshare. To view pdf files, we recommend using the adobe reader. Training competent authorities, in particular gmp inspectors. Standards and sanitary regulations, the following was issued. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. Mexico requests public comment on draft regulations for. Pesticides, vegetable nutrients and toxic substances 6. Medical device market in latin america brazil, mexico, colombia, chile and argentina together represent the 3rd largest economy in the world. This webinar will guide you on all exportimport regulations to mexico like an export declaration is required by u. Disposicion 23192002 requirements for gmp good manufacturing practices for foreign manufactures disposicion 21242011 post market surveillance program for medical devices. Disposicion 326620 mercosur technical regulation of good manufacturing practice for medicinal products and products for use in vitro diagnostics.
Mexico mexico approves additives for food and beverages. Companies producing medical devices for use in mexico must have good manufacturing practices certificates. One of the largest importers of medical devices, as well as a significant producer of such products, in the world, and certainly significant in latin america, is mexico. Mexico food and agricultural import regulations and standards. Drug registration in mexico regulatory affairs in latin america. Confusion still prevails within the cosmetic industry in how to interpret cosmetic regulation ec no 12232009 and the associated gmp iso 22716 and the implications of compliance for daily workflow. The wggmp proposed a plan for guideline validation, to the steering committee of the panamerican network for drug regulatory harmonization, which was approved and was developed in two parts. The manufacturing plant is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced. Ps inf 88 2019 qrm ec concept paper pqs effectiveness.
Pharmaceutical quality system guiding principles do you hold an establishment licence, or run an operation governed by part c, division 2 of the food and drug regulations. Disclaimer for educational purposes, some tables and graphs have been borrowed from an. Good manufacturing practices guide for drug products gui0001 page 10 of 156 about quality management 4. Based on health risks, cofepris determines if food and food products imported into mexico are subject to an import permit prior to importation. The 2020 pics seminar on how to be a good gmp inspector in 2020 will be taking place in bangkok thailand on 1820 november 2020, hosted by thai fda. Developing and promoting harmonised gmp standards and guidance documents. Recent trends please cite this article in press as. Medical devices regulatory compliance in latin america. Historical overview of pharmaceutical industry and drug regulatory.
Mexicos medical device regulations accept iso certifications, and dont seem to have specific good manufacturing practices requirements that may slow down the registration process. Imdrf presentation stakeholder mexico cofepris update. Federal commission for protection against sanitary risks and is the authority with competence to control and regulate drug products in mexico. What are good manufacturing practice gmp guidelines. The requirements for manufacturing highly active or. Because mexico considers fda and cmdcas certificates to be equivalent to its own cofepris, if a device is already certified in the united states or canada, the. In this chapter, we have studied that drug regulations and pharmaceutical industry has developed due to. Jan, 2017 we would like to recommend tying in the imp gmp guidance as much as possible into the existing gmp guidance eudralex vol. Dec 18, 2014 good manufacturing practice gmp is the minimum standard that a medicines manufacturer must meet in their production processes.
Historical overview of pharmaceutical industry and drug. Mexico cofepris approval process for medical devices. The addition of current reminds manufacturers that they must employ current technologies and systems in order. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Gmp fundamentals is a helpful guide which facilitates the entry into the gmp world and teaches the necessary basics. These devices are exempted by fda classification regulations published in the federal. Good manufacturing practices gmp are the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorization. Good manufacturing practice gmp shall be applied according to 21 cfr part 820.
Regulations of the general health law in matters of the health control of cannabis and its derivatives. Federal commission for the protection against sanitary risks cofepris, implements and enforces sanitary regulations, controls and promotions, to protect the population against health risks. The regulatory agency that promotes gmp in canada is health canada hc through the good manufacturing practices guide for drug products gui0001, 2018. The introduction specifies that the handbook was written with the intent of harmonising gmp regulations with those of other countries as well as the who, pics and ich. The draft regulations appear to require the submission of a gmp certificate to cofepris with respect to any foreignmanufactured, cannabiscontaining product classified as an herbal remedy under mexican law. First specific adaptations to general health law concepts and discussions on guidelinesinclude innovative all biotech products guidelines in health regulations for sbp biotech drug supplies. Ich q8 is intended to provide the regulators with a historical synopsis of the development of a drug product so that the agency may better understand the evolution of. Gmp regulations division 2 applicable to api activities1 1. Additional information there may be food and supplement additives still in use today that are not listed in the new agreement.