In a report published by the National Academies of Sciences, Engineering, and Medicine (NASEM), recommendations are given for the World Health Organisation (WHO) to expand its pre-qualification programme for diseases with a high global burden. Read more “Why should the WHO expand its pre-qualification programme for medical products?”
Category: Regulation
Regulatory news and updates
The principles behind the European Medical Device Nomenclature to support EUDAMED
The European Commission (EC) has released documents outlining the principles behind EUDAMED’s nomenclature. Read more “The principles behind the European Medical Device Nomenclature to support EUDAMED”
An important country-by-country list of the regulatory authorities in Asia and Oceania
The table below outlines various pharmaceutical and medical device regulators in Asia and Oceania, with links to their websites where available. Read more “An important country-by-country list of the regulatory authorities in Asia and Oceania”
Find out more about the hot topic of drug repurposing in regulatory affairs
Following on from an in-depth article in TOPRA’s Regulatory Rapporteur, this news item outlines our company’s additional views on the rationale behind drug repurposing. Read more “Find out more about the hot topic of drug repurposing in regulatory affairs”
Highlights from the most recent ICH convergence in Singapore
At the International Council for Harmonisation’s (ICH) meeting in Singapore, the status of activity of the ICH’s Working Groups was reviewed, including several important updates on implementation and communication. Read more “Highlights from the most recent ICH convergence in Singapore”
How is the EMA helping communities make a difference to the global response to HIV and AIDS?
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?”
How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?
Health Canada recently announced the creation of a new Medical Devices Directorate (MDD), to address the challenges and opportunities relating to the ever-changing landscape of the medical device industry. Read more “How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?”
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”
The EMA has published important guidance on the clinical development of new gout treatments
The finalised guidelines show the European Medicines Agency’s (EMA) expectations of manufacturers involved in the clinical development of new urate-lowering therapies (ULTs) and anti-inflammatory treatments of gout. Read more “The EMA has published important guidance on the clinical development of new gout treatments”