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Pharmacovigilance of Vaccines in the USA (US FDA)
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or...
Aug 30, 20244 min read
Pharmacovigilance of Biologics in the USA (US FDA)
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from...
Aug 30, 20244 min read
Biosimilars: Affordable and Effective Alternatives to Biologics
Biosimilars are biologic medical products that are highly similar to an already approved reference biologic drug. They are designed to...
Aug 21, 20244 min read
Hong Kong: New Drugs, Generics, Biosimilar Regulations
Hong Kong has a robust regulatory system for pharmaceuticals, overseen by the Department of Health (DoH).
Jul 10, 20244 min read
Biologics in Autoimmune Diseases: A New Hope for Patients
Biologics in Autoimmune Diseases:
Jul 2, 20244 min read
Biopharmaceutical Alliance Launched by India, South Korea, US, Japan, and EU
The global biopharmaceutical sector has taken a significant step towards ensuring a resilient drug supply chain with the formation of the...
Jun 7, 20243 min read
New Drugs, Generics and Biosimilar Registration in Singapore: Whitepaper on HSA Regulations
Guide to regulation in Singapore, insights into regulatory authorities, registration processes, & compliance for Drugs & Biosimilar
Apr 22, 20242 min read
Case Study: ASEAN Regulatory & Market Access Strategy for Japanese Pharmaceutical Manufacturer
Artixio, a leading consulting provider in the regulatory and commercial landscape, assisted a Japanese pharmaceutical company in...
Mar 7, 20242 min read
Biologics and Biosimilar Regulations and Registration in South Korea
The Korean pharmaceutical market is estimated to be worth $24.3 billion in 2019, and between 2015 and 2019, it grew at a compound annual...
Sep 6, 20235 min read
Biologics and Biosimilars Regulation and Registration in India (CDSCO)
The size of the Indian biosimilars market, which was anticipated to be worth $349 million in 2022, is expected to increase to $2108...
Sep 1, 20237 min read
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan's biosimilar business, with a market value of $140 million, accounted for just 5% of the...
Aug 31, 20235 min read
Biologics and Biosimilar Regulations and Registration in the European Union (EU) (EMA)
In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that the biosimilar...
Aug 28, 20235 min read
Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)
Mexico is the second-largest drug market in Latin America, after Brazil. With a compound annual growth rate (CAGR) of 38.7%, the Mexican...
Aug 23, 20235 min read
Biologics and Biosimilar Regulations and Registration in Brazil
According to the Drugs Sector Regulation Chamber (CMED) in 2022, the Brazilian pharmaceutical sector generated US $17.2 billion in sales...
Aug 17, 20235 min read
Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD 9.48 billion in 2022 and...
Aug 9, 20235 min read
Pharmaceutical Regulations in European Union
The European pharmaceutical market is expected to reach USD 432.12 billion by 2028, growing at a CAGR of 5.4%. Cancer therapeutics is...
Aug 1, 20237 min read
Pharmaceutical Registration Process in Mexico (COFEPRIS)
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the regulatory authority responsible for pharmaceutical...
Jan 13, 20227 min read
Regulation of Pharmaceuticals in Brazil by ANVISA
Registration pathway, regulations and documents required for registration of pharmaceutical, biologics, generic drugs, biosimilars in Brazil
Jan 12, 20225 min read
Insights
Global, Concurrent, Experience Based
Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.
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