The European Medicines Agency (EMA) is contributing to the global response to HIV and AIDS through scientific evaluation, supervision and safety monitoring of medicines, and active patient engagement. Read more “How is the EMA helping communities make a difference to the global response to HIV and AIDS?”
Category: International
The need for cross-sectoral, global cooperation to fight antimicrobial resistance
The statement emphasises the role of medicines regulators in efficiently bringing safe, effective and high quality antimicrobial products to the market, as well as minimising the regulatory barriers which can prevent access to essential treatments. Read more “The need for cross-sectoral, global cooperation to fight antimicrobial resistance”
FDA finalises guidance on smallpox drug development
As part of critical preparedness efforts, the United States (US) Food and Drug Administration (FDA) have published a final guidance to assist sponsors in the clinical development of drugs for treatment and prevention of smallpox (variola virus) infection. Read more “FDA finalises guidance on smallpox drug development”
ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators
The results of a recent survey released by the International Council on Harmonisation (ICH) suggest that pharmaceutical companies and regulators around the world are adopting and adhering to its guidelines on quality, safety and efficacy in drug development. Read more “ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators”
The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications
The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”
Biosimilar medicines: is further regulatory convergence required?
A biosimilar is a biological medicine which is highly similar, in terms of structure, activity, efficacy and safety, to another biological medicine (reference medicine) which is already approved by a regulatory authority. Read more “Biosimilar medicines: is further regulatory convergence required?”
The latest advancements on the use of artificial intelligence in drug development
Approximately 50% of late-stage clinical trials fail due to ineffective drug targets, meaning only 15% of drugs advance from Phase II trials to approval. Artificial intelligence (AI) can help to enhance drug development by making more accurate predictions in novel areas of biology and chemistry. Read more “The latest advancements on the use of artificial intelligence in drug development”
How can drug development be augmented for the treatment of hepatitis D?
Hepatitis D (HDV) is a replication-defective viral infection that uses the hepatitis B (HBV) surface antigen as its envelope protein. HDV infection can be associated with severe liver disease which can lead to cirrhosis, hepatocellular carcinoma and liver failure. Presently, there are no drugs approved for the treatment of this life-threatening disease. Read more “How can drug development be augmented for the treatment of hepatitis D?”
Addressing the world’s most pressing health challenges
The World Health Organisation (WHO) Digital Health Technical Advisory Group has agreed an action plan to focus its activities and priorities on advancing the digital health ecosystem whilst safeguarding the misuse of people’s data and protecting their health. Read more “Addressing the world’s most pressing health challenges”
Drug Shortages: What are the Root Causes and Potential Solutions?
A new report on the underlying factors responsible for drug shortages, and the potential solutions, has been published by a United States (US) Food and Drug Administration (FDA) task force. Read more “Drug Shortages: What are the Root Causes and Potential Solutions?”