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Does The Pandemic Present Opportunities To Rethink Regulatory Approaches?

Top Global Execs Share Views

 
• By Anju Ghangurde

Biocon chair believes new perspectives on regulatory science and processes emerging from the US's "Warp Speed" efforts to accelerate COVID-19 vaccines have potential for wider application, although Regeneron's president urges caution around relying only on small studies to advance repurposed drugs.

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Could Pandemic Bring New Perspectives To Regulatory Processes? • Source: Shutterstock

A recent healthcare summit discussed some interesting and potentially controversial dimensions around whether the coronavirus pandemic provides opportunities to rethink regulatory processes for therapeutics across the board without compromising on safety and efficacy aspects.

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Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 
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US Tariffs: With 50% Of US Generics From India, Industry Ponders If MAHA Will Trump MAGA

 
• By Vibha Ravi

US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.

More from Asia

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 
• By Urtė Fultinavičiūtė

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.