A practical overview of requirements for drug registration in ... - TOPRA

10Focus – Latin AmericaTable 2: Overall recommendations for successful global regulatory strategy including LATAM countries.ChallengeRecommendationRegulatorydifferencesacross the regionLanguage andcultural barriersInternal team’schallengesConstant changeto regulations inthe regionlllllllMaster the requirements or partner with regulatory professionals with knowledge of each country’s regulatory processWork within each set of requirements and associated timelines for each country where marketing authorisation is pursuedAwareness of these factors is critical for success in an environment often relying on relationships and negotiations wherethere are regulatory “grey areas”Work with reliable, knowledgeable experts, either at local or corporate headquarters, and either internal or via contracting partiesEngage regulatory affairs teams with knowledge of registration processes in LATAM early in the planning of global strategyThroughout the planning and execution process, effectively manage expectations with ex-regulatory teams who might questionunusual requests deviating from known EMA/FDA requirements or budget-consuming requisites: communication is keyMonitor frequently for updates to requirements or other regulatory developments.its intention to expedite the drug approval process by 40% by adoptingnew measures that include an electronic registration system. 16ConclusionsThe LATAM region does not have a centralised or harmonisedprocedure for drug registration. There are critical differences betweencountries in the region. Moreover, most countries require additionaldocumentation that is not part of Modules 2–5 of the CTD, some ofwhich might also be challenging to obtain. Table 2 lists the primarychallenges observed when working in the LATAM drug registrationprocesses and some key recommendation for success in the region.Knowledge of the drug registration processes and submissioncontent for each LATAM country is essential for the effective planningand execution of global regulatory strategy.Engaging regulatory professionals with expertise regardingthe region early in the development phase of a candidate productis crucial. Experts can be internal or external to the company butmust be, or have strategic partnerships with, reliable regulatoryprofessionals on the ground who are aware of the practical regulatorynuances and expectations from HAs, and who keep up-to-date withthe changes to the regulatory environment in the region, to avoiddelays or show-stoppers to the MA applications.Although not essential, there is an invaluable benefit if aregulatory affairs expert is fluent in the country’s language andcultural nuances in addition to having robust expertise in the localregulatory framework and practices.Local authorities in the region are eagerly learning from each otherand from other international agencies. There is rapid acceptance of newtechnologies and paradigms but above all, there is a fundamental driver:genuine concern for access to new therapies for local patients.References1 D Hill. ‘Latin America: High-Tech manufacturing on the rise, but outpacedby East Asia’, National Science Foundation, 2002.http://www.nsf.gov/statistics/infbrief/nsf02331/ (accessed 3 April 2013).2 World Health Organisation (WHO). ‘WHO policy perspectives on medicines -Effective medicines regulation: ensuring safety, efficacy and quality’, 2003. http://whqlibdoc.who.int/hq/2003/WHO_EDM_2003.2.pdf (accessed 3 April 2013).3 US Central Intelligence Agency (CIA). ‘The World Factbook’. https://www.cia.gov/library/publications/the-world-factbook/index.html (accessed on 13 April 2013).4 The World Bank Group. http://www.worldbank.org/ (accessed on 13 April 2013).5 Population Europe. http://www.population-europe.eu/(accessed on13 April 2013).6 Pan American Health Organization, PAHO-PANDRH website. http://new.paho.org/hq/index.php?option=com_content&view=category&layout=blog&id=1156&Itemid=3865&lang=en (accessed on 14 April 2013).7 PAHO. ‘PAHO recognizes COFEPRIS as a National Regulatory Authority ofRegional Reference’. http://new.paho.org/hq/index.php?option=com_content&view=article&id=6967&Itemid=1926 (accessed on 16 April 2013).8 COFEPRIS. ‘El Salvador y Ecuador, primeros países en reconocer registrosde medicamentos de México’, Press release from COFEPRIS, GobMx, 2012.http://www.encuentra.gob.mx/resultsAPF.html?q=EL%20SALVADOR%20y%20ECUADOR%2C%20PRIMEROS%20PA%C3%8DSES%20EN%20RECONOCER%20REGISTROS%20DE%20MEDICAMENTOS%20DE%20M%C3%89XICO&client=cofepris (accessed on 16 April 2013).9 National Administration of Drugs, Foods and Medical Devices(Administración Nacional de Medicamentos, Alimentos y TecnologíaMédica, ANMAT) webpage (Argentina). http://www.anmat.gov.ar/principal.asp (accessed on 7 April 2013).10 National Agency of Sanitary Surveillance (Agência Nacional de VigilânciaSanitária, ANVISA) webpage (Brazil). http://portal.anvisa.gov.br/wps/portal/anvisa-ingles/anvisaingles (accessed on 7 April 2013).11 Public Health Institute (Instituto de Salud Pública, ISP) webpage (Chile).http://www.ispch.cl/ (accessed on 7 April 2013).12 National Institute of Drug and Food Monitoring (Instituto Nacional deVigilancia de Medicamentos y Alimentos, INVIMA) webpage (Colombia).http://www.invima.gov.co/ (accessed on 25 April 2013).13 Federal Comission for the Protection against Sanitary Risks (Comisión Federalpara la Protección contra Riesgos Sanitarios, COFEPRIS) webpage (Mexico). http://www.cofepris.gob.mx/Paginas/Idiomas/Ingles.aspx (accessed on 7 April 2013).14 General Directorate of Medicines, Supplies and Drugs (Dirección Generalde Medicamentos, Insumos y Drogas, DIGEMID) webpage (Peru). http://www.digemid.minsa.gob.pe/ (accessed on 7 April 2013).15 National Institute of Hygiene “Rafael Rangel” (Instituto Nacional de Higiene“Rafael Rangel”, INHRR) webpage (Venezuela). http://www.inhrr.gob.ve/index.php (accessed on 30 April 2013).16 ANVISA. “ANVISA adopts measurements to accelerate submissionsreview” Newsroom, ANVISA webpage. http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2013+noticias/anvisa+adota+medidas+para+acelerar+analise+de+registro (accessed on 21 April 2013).Regulatory Rapporteur – Vol 10, No 9, September 2013www.topra.org