Canadian pharmaceutical gmp regulations compared and contrasted to usfda gmps by richard k. Developing and promoting harmonised gmp standards and guidance documents. Cofepris and good manufacturing practices certificates. Pharma regulatory affairs in mexico linkedin slideshare. 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. Although, this is the case, however, there is some confusion as to what mexicos requirements and regulations are for. The dietary supplement health and education act passed in 1994. Jul 23, 2012 mx2052 mexico approves additives for food and beverages page 3 annex x. Iran ifda, turkey tmmda and mexico cofepris will become the 50th, 51st and 52nd.
Regulations of the general health law in matters of the health control of cannabis and its derivatives. 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 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. Canadian pharmaceutical gmp parenteral drug association. Recent trends please cite this article in press as. Disclaimer for educational purposes, some tables and graphs have been borrowed from an informative cofepris presentation. Based on health risks, cofepris determines if food and food products imported into mexico are subject to an import permit prior to importation. Qs regs for device good manufacturing practices fda. Brazil is a member of mercosur and many of the laws are harmonized with the mercosur directives.
The addition of current reminds manufacturers that they must employ current technologies and systems in order. In addition to drug products, the cofepris is in charge of food and beverages, tobacco products, other healthcare. Good manufacturing practice gmp shall be applied according to 21 cfr part 820. Based on health risks cofepris determines if food and food products imported into mexico should be subject to an import permit previous to importation.
Latest developments in biologic and biosimilar regulation. New mexican regulations for food products are the result of the so called crusade against overweight and obesity established by the current government. The requirements for manufacturing highly active or. Gmp verification is required by cofepris in the following cases. Chapter 1 pharmaceutical quality system 31 january 20 chapter 2 personnel 16 february 2014. Regulatory update manufacturing quality mexicos cofepris. European union the european medicines agency emea is a decentralized body of the european union. Good manufacturing practices, en es, nom 241 ss a12012, 112012. 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. Gmp fundamentals is a helpful guide which facilitates the entry into the gmp world and teaches the necessary basics. Mexico cofepris approval process for medical devices. Disposicion 326620 mercosur technical regulation of good manufacturing practice for medicinal products and products for use in vitro diagnostics.
The chart shown illustrates the cofepris approval process in mexico and is available for download in pdf format. Cofepris is a decentralized entity of the ministry of health with. Medical devices regulatory compliance in latin america. We would like to recommend tying in the imp gmp guidance as much as possible into the existing gmp guidance eudralex vol. This webinar will guide you on all exportimport regulations to mexico like an export declaration is required by u. Eu gmp guidelines for human and veterinary medicinal products. These laws and regulations are evolving and are not transparent. Additional information there may be food and supplement additives still in use today that are not listed in the new agreement. Fda cofepris mexico, confidentiality commitment english.
Some devices of class i are exempt from gmp requirements 4. The following guideline can be ordered through the address listed in the sourcepublishercategory. The manufacturing plant is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced. Part of the health products and food branch inspectorate inspectorate program is to. 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.
Gmp inspections by cofepris regulatory affairs in latin. Regulatory affairs in emerging markets prague, october 20 2. Drug registration in mexico regulatory affairs in latin america. Good manufacturing practices guide for drug products gui0001 page 10 of 156 about quality management 4. Pharma regulatory affairs in mexico maria ines guaia informa conference. 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. Based on health risks, cofepris determines if food and food products imported into mexico. Medical device market in latin america brazil, mexico, colombia, chile and argentina together represent the 3rd largest economy in the world.
Registering medical devices in mexico market access. 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. Mx2052 mexico approves additives for food and beverages page 2 general information. 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. This law also covers good manufacturing practices gmp applicable for. Cofepris is an agency with broad regulatory powers, which main activity is the prevention against sanitary risks. Enroute, foreign manufacturers might face challenges. Dec 18, 2014 good manufacturing practice gmp is the minimum standard that a medicines manufacturer must meet in their production processes. Gmp certificate for manufacturing site of finished product. Fda has determined that certain types of medical devices are exempt from gmp requirements. The regulatory agency that promotes gmp in canada is health canada hc through the good manufacturing practices guide for drug products gui0001, 2018.
Gmp iso 22716 and cosmetics regulation ec no 12232009. In october 20, the mexican health authority released a new document setting the criteria that will be used to accept gmp certificates as valid. 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. A guide for importing medical equipment into brazil. Cpp who gmp manufacturing license free sale certificate letter of authorization power of attorney. Food laws and regulations in mexico fda compliance. Mexico food and agricultural import regulations and standards.
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. The international standards for risk management iso 14971 and biocompatibility iso 10993 are accepted 11. The following regulation impact the medical equipment and medical devices industry. Imdrf presentation stakeholder mexico cofepris update. 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 good manufacturing practices gmp certificate of the manufacturer. Good manufacturing practices guide for drug products. 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. For all food manufacturers this is a must study topic. Disposicion 23192002 requirements for gmp good manufacturing practices for foreign manufactures disposicion 21242011 post market surveillance program for medical devices. Cofepris regulates the following industries and business process. 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.
All the projects of technical regulations that impact on international trade, even if those regulations are identical to international standards, are notified to wto. 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. Part of the health products and food branch inspectorate inspectorate program is to conduct inspections of establishments that are. Regulatory collaboration world health organization. What are good manufacturing practice gmp guidelines. Gmp inspections by cofepris regulatory affairs in latin america. 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. Ps inf 88 2019 qrm ec concept paper pqs effectiveness. To follow are five common causes of confusion that tend to occur in interpreting these regulations and good manufacturing practices. Latest developments in biologic and biosimilar regulation mexico has over several years clarified the ip rules that apply to biotechnology products. Mexico food and agricultural import regulations and. Training competent authorities, in particular gmp inspectors. Gmp regulations division 2 applicable to api activities1 1.
Historical overview of pharmaceutical industry and drug. Cofepris to accept the be study performed in india against mexico reference product. Reference document canada the health canada revised guidance document entitled good manufacturing practices guidelines as provided for comment december 8, 2006. Using practical examples and comparisons to everyday life will help to easily understand gmp regulations. If you do, you must make sure that you comply with these. 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. Labeling of medical devices united mexican states ministry of health. Pesticides, vegetable nutrients and toxic substances 6.
In early may 2018, mexico notified the world trade organization wto of draft regulations from mexicos federal commission for the protection against sanitary risks cofepris with regard to cannabis and its derivatives. Chapter 57 what are good manufacturing practice gmp guidelines. This translation may not be reproduced online or in any other format without written permission from emergo group. Federal commission for the protection against sanitary risks cofepris, implements and enforces sanitary regulations, controls and promotions, to protect the population against health risks. We also can help you register your medical devices with cofepris in mexico. Historical overview of pharmaceutical industry and drug regulatory. Health care expenditure is increasing considerably medical device imports is key for regions development exports are very low. Rdc 5900 is the only regulation not fully enforced. Mutual recognition agreements mras information on mutual recognition agreements between eu and noneu countries. 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. 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. Mexico requests public comment on draft regulations for. Jan, 2017 we would like to recommend tying in the imp gmp guidance as much as possible into the existing gmp guidance eudralex vol. 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.
Mexicos medical device regulations accept iso certifications, and dont seem to have specific good manufacturing practices requirements that may slow down the registration process. Under the health law regulations and noms, cofepriss. Mexico at the vanguard late 90s 1997 1998 2004 2005 some legal modification of inclusion of some usa eu started eu. 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. Good manufacturing practice gmp is the minimum standard that a medicines manufacturer must meet in their production processes. Overview mexico stands a favorite destination for medicines and medical device manufacturers to explore the pharmaceutical market opportunities. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda.
Federal commission for protection against sanitary risks and is the authority with competence to control and regulate drug products in mexico. For new registration and manufacturing changes of biologic, biotech and hemoderivate products. This criteria applies to certificates of manufacturing facilities both of finished products and api. Companies producing medical devices for use in mexico must have good manufacturing practices certificates. Good manufacturing practices for medicinal products nom059ssa12015. 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. Iran ifda, turkey tmmda and mexico cofepris accede to pics. These devices are exempted by fda classification regulations published in the federal. It is not an official translation provided by cofepris. Navigating differences between fda and emea for regulatory. Latin american countries regulatory requirements overview. Importance of quality risk management in pharmaceutical quality systems.
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. 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. 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. Mexico mexico approves additives for food and beverages.
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