Regulatory Rapporteur
Write to the Editor at publications@topra.org
April 2023 | Volume 20 | No.4
EDITORIAL
The region walking the regulatory walk
Latin America is a large market with considerable promise for pharmaceutical growth, with a potential patient population of more than 600 million people. The landscape in Latin America is changing quickly, with demand growing as the population ages and chronic diseases become commonplace.
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By Victoria Goff and Marie Deneux
FOCUS
Patients are at the centre of everything
Yaneth Giha, Executive President at FIFARMA, finds and implements solutions to enhance patient outcomes. She discusses the Association’s focus and mission, and the key changes to look out for in the Latin American market.
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By Cristina Mota
FOCUS
The transition period for the new API framework in Brazil is coming to an end
The transition period for adapting to the new regulatory framework for active pharmaceutical ingredients will end on 1 August 2023. This article discusses what industry has learnt during the transition period, and what to expect from the new framework.
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By Sabine Winkler
FOCUS
Registration and post-approval variation
of pharmaceutical drugs in Latin America:
challenges and opportunities
The pharmaceutical industry in Brazil relies mostly on imports, and foreign manufacturers need to meet different agencies’ requirements for registration of imported drug products. This article identifies the challenges of pharmaceutical drug registration, and post-approval changes for foreign manufactures.
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By Akash Jain, Khushboo Vishwakarma, and Kajal Gawde
FEATURE
Does sole dependence on reliance models
contribute to a sustainable healthcare ecosystem?
Reliance models see a gap between approvals in stringent regulatory authority, and the reliance market. Regulatory frameworks must be optimised to ensure health equality, especially during a global health emergency. This article focuses on regulatory systems in the international region, and the experience gained through Vaxzevria’sTM vaccine case study.
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By Priti Shah and Anna Litsiou
FEATURE
An overview of the regulatory framework
for advanced therapies
Advanced therapy medicinal products (ATMPs) are a rapidly developing market, and recent advances in the field have been subject to regulation in some countries. This article summarises the regulatory framework for ATMPs across several countries and regions.
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By the Regulatory Affairs Workgroup, SINDUSFARMA
FEATURE
Contraceptive product registration:
regional harmonisation through
the East African Community mechanism
The COVID-19 pandemic disrupted access to contraception as a result of supply chain challenges, staff shortages, and lockdowns. This article looks at Catalyst Global’s experience in registering the contraceptive product, AVIBELA, using the East African Community Medicines Regulatory Harmonisation Initiative.
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By Courtney Stachowski, Wilberto Robles, Ashley Jackson, Danielle M. Harris, Emily Morris, Kelly Dannucci, Kate H. Rademacher
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