top of page
Search
Real World Evidence (RWE) in Pharma Innovations
Real-World Evidence (RWE) refers to clinical evidence obtained from real-world data (RWD) on the use and potential benefits or risks of a...
Oct 22, 20244 min read
Pharmaceutical Patents Expiry: Generic Drug Development
As blockbuster drugs face patent expiries, pharmaceutical companies are adopting a range of strategies to navigate the resulting...
Oct 21, 20244 min read
Impact of Drug Patent Expiry on Prices: Recent Trends
Patent expiry marks a significant milestone in the lifecycle of a pharmaceutical product. When a drug is first developed, the...
Oct 19, 20245 min read
Therapeutic Goods Administration TGA Regulation of Non-Prescription Medicine in Australia
In Australia, the regulatory agency responsible for non-prescription medicines is the Therapeutic Goods Administration (TGA). The TGA is...
Oct 15, 20246 min read
EMA Measures Towards Efficient Approval Process for New Medicines in European Union (EU)
Improving the efficiency of the approval process for new medicines within the European Medicines Agency (EMA) involves several strategies...
Oct 13, 20243 min read
EMA's Clinical Trial Regulations (EUCTR) in European Union
The new EU Clinical Trial Regulation (CTR) 536/2014, which came into effect on January 31, 2022, represents a significant overhaul of the...
Oct 5, 20246 min read
NADFC (BPOM) Regulation of Pharmaceuticals in Indonesia
The pharmaceutical market in Indonesia is one of the largest in Southeast Asia, driven by a combination of factors such as a large...
Sep 28, 20247 min read
What Is a Marketing Authorization Holder (MAH)?
Marketing Authorization Holder is an entitythat holds the regulatory approval to distribute, sell, and commercialize pharmaceutical products
Sep 6, 20243 min read
COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico
COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico
Sep 2, 20246 min read
The Use of Virtual Reality (VR) and Augmented Reality (AR) in Pharma Training and Education
As the technology continues to evolve, the use of Virtual Reality (VR) and Augmented Reality (AR) in Pharma Training and Education is...
Aug 29, 20245 min read
Regulatory Challenges in Bringing Generic Drugs to the Market Post-Patent Expiry
Generic drugs are medications that are created to be equivalent to brand-name drugs in terms of dosage form, safety, strength, route of...
Aug 29, 20243 min read
Patent Expiry Alert: Blockbuster Drugs Expected to Lose Protection in the Next Five Years
Patent expiry refers to the end of the legal protection period granted to a patented invention or product. When a pharmaceutical company...
Aug 23, 20243 min read
US FDA Pharmacovigilance Requirements for Drugs in the USA
Pharmacovigilance is a cornerstone of drug regulation in the USA, playing a crucial role in ensuring the safety and efficacy of medicinal...
Aug 13, 20244 min read
Artificial Intelligence (AI) and Machine Learning (ML) in Drug Discovery
Artificial Intelligence (AI) and Machine Learning (ML) in drug discovery offer new possibilities for accelerating the drug development...
Aug 9, 20244 min read
Microbiome Based Therapies : Regulations and Market Outlook
Microbiome-based therapies are a promising area in precision medicine, aiming to tailor treatments based on individual microbial...
Aug 7, 20246 min read
US FDA Regulation of Nitrosamines in the USA
Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked...
Jul 26, 20245 min read
Innovative Drug Delivery Systems
While traditional oral pills remain a cornerstone of drug delivery due to their simplicity and familiarity, innovative drug delivery...
Jul 26, 20245 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
Case Study: Regulatory Compliance and Registration of AI algorithm with MoHAP, UAE
Registration of AI algorithm with MoHAP UAE
Jul 2, 20243 min read
Precision Medicine – Key Players and Pipeline
Precision medicine, with its promise of tailoring treatments to individual patient characteristics, is revolutionizing the healthcare...
Jun 27, 20247 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.
bottom of page