ANVISA-Brazil; BRICS (Brazil, Russia, India, China), 2019 (MOU between the BRICS health regulatory authorities; http://brics2019.itamaraty.gov.br/images/documentos/20191111_MoU_TIPAs_BRICS.pd; was accessed until Dec 2021)To promote common solutions in the area of sanitary regulation; also to establish bases for a more structured dialogue and encourage the adoption of good regulatory practices, based on international regulatory convergence; Type of products: Product requires a sanitary authorization.Fifth meeting of the BRICS health regulatory authorities, improving the transparency of the drug, vaccine and other health products markets universal coverage of vaccines and regulatory paths to favor trade in immunobiologics between countries; the local or global scarcity of health products and the necessary procedures for sanitary authorization for the use of products in these cases, through the rapid exchange of information or other alternativesBrazil: Brazilian APEX Brazil's president;
Russia: Ministry of Economic Development;
China: Investment Promotion Agency of Ministry of Commerce of China; Trade Development Bureau of Ministry of Commerce of China;
South Africa: Tisa's Head; INVETSA's Head;
India: Invest India's Managing Director and CEONot definedYesANVISA-Brazil; Swissmedic- Switzerland, 2012 (MOU concerning cooperation in the regulation of therapeutic products; https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/bilateral-collaboration-with-partner-authorities/agreements-on-information-exchange.html)To promote an understanding between the Participants of each other's regulatory framework, requirements and processes; to facilitate the exchange of information and documentation relating to the regulation and conformity assessment of therapeutic products; to encourage the development of collaborative activities between the participants; and to enhance the ability of the participants in the provision of their services relating to or in connection with public health, to meet the needs of their respective population; Type of products: all types of therapeutic products regulated by the participants and permit meaningful collaboration between them.Establish avenues of communication to facilitate the exchange of information about the regulation and conformity assessment of therapeutic products by each participant, including: policies, practices, standards, laboratory testing, premarket assessment, postmarket vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic products; and undertake collaborative activities, including, where practical, the exchange of personnelSwitzerland: Swissmedic's representative;
Brazil: ANVISA's representative;
The digital public version no declares the signers positionsNot definedYesCOFEPRIS México; AEMPS-Spain, October 2016 (MOU for regulatory cooperation; https://www.aemps.gob.es/informa/notasinformativas/laaemps/2016/ni-aemps_13-2016-aemps-cofepris/?lang=en)To establish avenues of communication to facilitate the exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, pre-market assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, and requirements for the regulation of therapeutic products; to foster the efficiency in processes related to medicines, included marketing authorization and GMP for allopathic, organic synthesis, biological and biotechnological products and active substances; to develop cooperation activities fostering experiences exchange related to tolerability and vigilance; Type of products: raw materials and pharmaceutical products, biological, biotechnological products and medical devicesRegulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, and requirements for the regulation of therapeutic products; processes related to medicines, included marketing authorization and GMP for allopathic, organic synthesis, biological and biotechnological products and active substances; tolerability and vigilanceMéxico: COFEPRIS’ director;
Spain: AEMPS’ directorNot definedIt was not possible to confirm itCOFEPRIS Mexico; ISP-Chile, September 2012 (MOU; https://www.ispch.cl/wp-content/uploads/2021/05/Convenio-Cofepris.pdf)To promote the information and documentation exchange and collaboration; Type of products: medicineTo establish avenues of communication to facilitate the exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic products; GMPMexico: COFEPRIS's legal representative;
Chile: ISP's legal representativeMutual decision or for initiative of one of themYesINVIMA Colombia; AEPMS Spain, 2014 (MOU for regulatory cooperation https://www.invima.gov.co/documents/20143/347733/K-±MEMORANDO±DE±ENTENDIMIENTO±AEMPS±-±INVIMA.pdf/a23e214b-30ed-ca9f-9282-3db824717094; accessed until December 2021)To promote an understanding between the participants of each other's regulatory framework, requirements and processes and reinforce the collaboration; to exchange of experts in evaluation of biological, biotechnological products, vaccines, and rare diseases products
Type of products: all products regulated by both participantsTo establish avenues of communication to facilitate the exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic products; GMPColombia: INVIMA's director;
Spain: AEMPS's directorUnder mutual agreementYesINVIMA Colombia; ISP Chile, September 2013 (MOU https://www.invima.gov.co/documents/20143/347733/G_MEMORANDO±DE±ENTENDIMIENTO±INVIMA-ISP.PDF/a0944281-a79e-0106-4e37-e325b9713c0f accessed until December 2021)To promote an understanding between the participants of each other's regulatory framework, requirements and processes and reinforce the collaboration and improve participants’ capacities on public health
Type of products: medicines, medical devicesThe exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, post-market vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic productsColombia: Invima's director;
Chile: ISP's directorWhen one of participants decide to finish it or for mutual agreeYesINVIMA Colombia; DIGEMID-Perú, October 2015 (MOU; https://www.cancilleria.gov.co/sites/default/files/Normograma/docs/memorando_ms_invima_digemid.htm; accessed until December 2021)To promote an understanding between the participants of each other's regulatory framework, requirements and processes; to facilitate the exchange of information and documentation relating to the regulation and conformity assessment of therapeutic products; biologics, medical devices, cosmetics; to encourage the development of collaborative activities between the participants
Type of products: medical products and biologicsTo establish avenues of communication to facilitate the exchange of information about the regulation of therapeutic products by each participant, certificates, postmarket vigilance, market compliance, regulation of manufacturers, GMPColombia: INVIMA's general director, Ministry of Health;
Perú: DIGEMID's director, Ministry of Health3 y and is automatically renewedYesINVIMA Colombia; ARCSA Ecuador, August 2015 (MOU https://www.invima.gov.co/documents/20143/347733/D-±MEMORANDO±DE±ENTENDIMIENTO±ARCSA±E±INVIMA.pdf/1077d9f3-96eb-d185-2122-7d34b02fbd7c accessed until December 2021)To promote an understanding between the participants of each other's regulatory framework, requirements and processes and reinforce the collaboration
Type of products: all products regulated by both participantsTo establish avenues of communication to facilitate the exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic products; GMPColombia: INVIMA's director;
Ecuador: ARCSA's directorMay be terminated at any time, by either; participant preferably by notice with 90 days in advanceYesINVIMA Colombia; DNM El Salvador, February 2016 (MOU https://www.invima.gov.co/documents/20143/347733/B_MEMORANDO±DE±ENTENDIMIENTO±ENTRE±DNM±E±INVIMA.pdf/93e043c3-81f7-7620-1d02-1aa5bca686c3 accessed until December 2021)To ensure supply of products and collaboration between both countries
Type of products: medicine, medical devicesThe exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic products; GMPColombia: INVIMA's director;
El Salvador: DNM's legal representative5 y (2016–2021); there is no evidence of its renewalYesINVIMA Colombia; ANMAT Argentina, February 2014 ( MOU; https://www.invima.gov.co/documents/20143/347733/I-MEMORANDO+DE+ENTENDIMIENTO+ANMAT-INVIMA.pdf/c2eb0c73-e318-f18d-94c8-3506a75c22a3)To promote information exchange to reinforce the NRA re-certification by WHO; to promote collaboration activities
Type of products: all products regulated by both participantsInformation exchange regard mechanisms to evaluate sanitary technologies focus on medicines and medical devices; exchanges of medicines, medical devices, foods regulations; any other cooperation way agreed between partsColombia: INVIMA's director;
Argentina: ANMAT's national administratorMay be terminated at any time, by either participantYesISP Chile; AEMPS Spain, October 2018 (MOU; https://www.ispch.cl/wp-content/uploads/2021/05/CONVENIO-AEMPS.pdf)To promote the information and documentation exchange and collaboration
Type of products: products registered and submittedThe exchange of information about the regulation of therapeutic products by each participant, including policies, practices, standards, laboratory testing, premarket assessment, certificates, postmarket vigilance, market compliance, regulation of manufacturers, regulation of clinical trials and requirements for the regulation of therapeutic productsChile: ISP's director;
Spain: AEMPS’ director3 y (it is not clear whether was renewal)Yes