All COVID-19 articles
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Industry newsCovid vaccines ‘not to be offered routinely’ to healthy under-65s
Only over-65s will get vaccination offered this year, the Joint Committee on Vaccination and Immunisation has advised UK government.
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Industry newsBurkina Faso gives R21 malaria vaccine approval in children
Burkina Faso’s regulatory agency – Agence Nationale de la Regulation Pharmaceutique – has approved the R21/Matrix-M malaria vaccine for children.
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Industry newsGood safety profile of COVID-19 vaccines declared by ICMRA
COVID-19 vaccines show a very good safety profile in all age groups, including people with underlying medical conditions and pregnancy.
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Industry newsWHO says COVID-19 ‘no longer a global health emergency’
SARS-Cov-2 – which caused the COVID-19 pandemic – “no longer a public health emergency of international concern”: WHO.
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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. -
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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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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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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JournalDigital and data-driven: information management at the EMA
Dr Hilmar Hamann, Head of Information Management Division at the EMA, discusses key milestones in his career, the challenges faced and his long-term visions for information management legislation
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Journal10 years of pharmacovigilance legislation: the perspective of a national agency
In 2012, the new pharmacovigilance legislation came into force, which established a uniform standard for the safety monitoring of medicines in Europe. These new legal requirements resulted in impactful changes, including the creation of a further scientific committee at the European Medicines Agency’s (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC). It also resulted in a new framework for signal management, the establishment of a periodic safety update report (PSUR) single assessment and additional requirements for risk management plans (RMPs). This article reflects upon the past 10 years’ experience, including the recent pandemic. Suggestions are made on areas where the legal framework may need to be further adapted to a changing regulatory environment.
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Meeting ReportThe DIA’s accelerating CMC workshop
The Drug Information Association’s (DIA) virtual accelerating chemistry, manufacturing, and controls (CMC) workshop, held between 28 to 30 September 2021, consisted of seven sessions. The workshop included presentations by representatives from industry, industry bodies, health authorities and regulatory governance bodies.
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FocusRegulating medicines in a surge of change
RegRap speaks to Steve Hoare, Quality Regulatory Science and Safety Policy Director at the ABPI
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InterviewBuilding best regulatory practices in Brazil
Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.
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Meeting ReportHM6: Clinical trials of the future – patient orientated and digitally connected
Susan Bhatti started the session by welcoming everyone and clarifying that the aim of the meeting was to discuss how clinical trials can be transformed by using digital technologies to enrol and monitor patients, resulting in more inclusive, flexible, connected and patient-centred studies.