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?”
News
Pilot for Reporting Illicit Drug Reactions to be discontinued
Public Health England (PHE) have decided to close the 2017 Reporting Illicit Drug Reactions (RIDR) pilot programme by 28 February 2020. Read more “Pilot for Reporting Illicit Drug Reactions to be discontinued”
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”
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”
What are the latest recommendations for improving the delivery of Complex Innovative Design cancer trials?
A group of UK experts have made recommendations on the use of Complex Innovative Design (CID) cancer trials. Read more “What are the latest recommendations for improving the delivery of Complex Innovative Design cancer trials?”
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”
EMA Management Board meeting highlights the upcoming challenges in 2020
Following three years of relocation and workforce changes, the European Medicines Agency has outlined the challenges to come, in its December Management Board meeting. Read more “EMA Management Board meeting highlights the upcoming challenges in 2020”
Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?
UK Marketing Authorisation Holders (MAH) should be reviewing their manufacturing processes to identify and diminish any risk of the presence of nitrosamine impurities in their medicines. Read more “Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?”
A 4-year overview of pharmacovigilance activities in the EU
A report carried out by the European Medicines Agency (EMA) in collaboration with national competent authorities of European Union (EU) Member States, has shown that the EU pharmacovigilance (PV) system is robust and effective at ensuring the safety of medicines. Read more “A 4-year overview of pharmacovigilance activities in the EU”