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: International
Addressing concerns surrounding China’s API manufacturing quality
The European Commission (EC) and European Medicines Agency (EMA) will collaborate with China’s National Medical Products Administration (NMPA) to conduct a gap analysis on the Chinese and EU regulatory systems for active pharmaceutical ingredients (API). Read more “Addressing concerns surrounding China’s API manufacturing quality”
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”
International regulators launch sterile medicines inspection pilot
A two-year pilot programme for international collaboration in good manufacturing practice (GMP) inspections of manufacturers of sterile medicines has been announced. Read more “International regulators launch sterile medicines inspection pilot”
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”
The discovery of NDMA impurities in a common diabetes drug
Singapore’s Health Sciences Authority (HSA) has recalled three locally marketed metformin medicines after it was discovered that they contained N-nitrosodimethylamine (NDMA) impurities. Read more “The discovery of NDMA impurities in a common diabetes drug”
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?”
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”