Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America
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Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America Ana Padua1 · Livia Partika1 · Denise Bonamici1 · Juliana Rahal Cabello1 · Cristiane Kohiyama1 · Paula Spinardi1 · Anabelle Castro1 · Alessandra Rolim1 · Francisco Souto1
© Springer Nature Limited 2020
Abstract Countries worldwide have introduced new regulations to accelerate drug regulatory review to afford faster access to medicines, mainly for patients with no or limited therapeutic alternative without compromising the quality, efficacy, and safety of the drug. We mapped and analyzed accelerated regulatory pathways in 19 countries from Latin America (LATAM). Pathways included acceptance of Phase II studies, when justified, and requirement of a Certificate of Pharmaceutical Product (CPP) for regulatory submission or approval for a drug. We present a regional regulatory overview of innovative pathways to accelerate assessment of medicines by regulators to benefit patients in need. Most LATAM regulators we surveyed have implemented accelerated pathways. Adoption of good regulatory practices is key for success (World Health Organization, WHO, Good Regulatory Practices: guidelines for national regulatory authorities for medical products (World Health Organization, WHO, Good Regulatory Practices: guidelines fornational regulatory authorities for medical products. World Health OrganizationQAS/16.686. WHO, 2016. https:// www.who.int/medicines/areas/quality_safety/quality_assurance/GoodRegulatory_ PracticesPublicConsult.pdf). Keywords Reliance · Expedited review · Accelerated regulatory pathways in LATAM · Good regulatory practices · Unmet medical needs
Regulatory Affairs Professionals in Pharmaceutical Industry with expertise in LATAM region. * Ana Padua [email protected] 1
Chemin de l’Oche l’Abbé 3, 1112 Echichens, Switzerland Vol.:(0123456789)
A. Padua et al.
Introduction Numerous public health emergencies require quick access to medicinal products. Pandemics, natural disasters, military emergencies, disease outbreaks, and emerging diseases are among the causes of situations needing rapid response. Regulators must act to protect the health of their populations at the speed required by the clinical circumstances [2]. Regulators adopt accelerated regulatory pathways to shorten duration of regulatory reviews to meet urgent public health needs in a globalized world where contagious diseases unexpectedly spread at very high speed [2]. Creating awareness about availability of accelerated regulatory pathways in Latin American countries may contribute to public engagement to encourage their use. Regulators ultimately decide the outcome. Regulators worldwide have implemented innovative registration pathways to address unmet medical needs to treat serious or life-threatening diseases or conditions without compromising the final quality, efficacy, and safety of the drug [3]. ‘Unmet medical needs’ refer to conditions for which no satisfactory method of diagnosis, prevention, or authorized treatment e
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