All Regulatory Rapporteur articles in April 2023
View all stories from this issue.
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JournalAn overview of the regulatory framework for advanced therapies
Advanced therapy medicinal products (ATMPs) have recently advanced in development and are subject to regulation in some markets. This article summarises the regulatory framework for ATMPs in some of the markets where these requirements are in place: Argentina, Brazil, Europe, and the US.
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JournalContraceptive product registration:
regional harmonisation through the East African Community mechanismThe COVID-19 pandemic disrupted access to contraception as a result of supply chain challenges, staff shortages and lockdowns, to name a few. 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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JournalRegistration and post-approval variation of pharmaceutical drugs in Latin America:
challenges and opportunitiesThis article provides an overview of the critical challenges for pharmaceutical drug registration and post-approval changes for manufacturers in six major Latin American countries.
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JournalThe transition period of the new API framework in Brazil is coming to an end
The new active pharmaceutical ingredients regulatory framework in Brazil begins August 2023
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InterviewPatients are at the centre of everything
Yaneth Giha, Executive President, FIFARMA, finds and implements solutions to enhance patient outcomes.
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EditorialThe region walking the regulatory walk
Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.
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JournalDoes sole dependence on reliance models contribute to a sustainable healthcare ecosystem?
Governments should strive for a sustainable and global regulatory framework adept to deal with a healthcare crisis and similar issues that may arise in the future. This article looks at regulatory frameworks in international regions through AstraZeneca’s experience with the VaxzevriaTM vaccine.
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PodcastsRegRapPod – April 2023
Vol. 20 #4
Our new RegRapPod – the first episode of our podcast series – is available to listen to now. April’s Issue Editor, Vickie Goff discusses Latin America articles with podcast host Alan Booth, who also hears from authors Priti Shah and Anna Litsiou whose article this month is covered in a full interview in a later edition. -
PodcastsRegulating Vaxzevria
Vol. 20 #4
MEMBER EXCLUSIVE:
Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]. Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria.