The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network (EMRN) to oversee the harmonised implementation of the CHMP opinion on nitrosamines in human medicinal products. Read more “EMA’s Nitrosamine Implementation Oversight Group”
Category: Medicinal product
A summary of recent TGA regulatory updates
As Australia continues to improve its regulatory framework, the Therapeutic Goods Administration (TGA) has regularly released new and updated materials concerning the regulation of both medicines and devices. A summary of the recent updates are provided below. Read more “A summary of recent TGA regulatory updates”
European Commission initiative to revamp pharmaceutical legislation
In November 2020, the European Commission (EC) adopted its Pharmaceutical Strategy for Europe in which one commitment was to conduct a review of its pharmaceutical legislation. The EC has now released a roadmap outlining how it plans to deliver this regulatory overhaul. Read more “European Commission initiative to revamp pharmaceutical legislation”
Detailed guidance on the Target Development Profile Toolkit
When the Innovative Licensing and Access Pathway (ILAP) was launched at the start of 2021, it was announced that the Target Development Profile (TDP) will be available to applicants to support their application through this pathway. Read more “Detailed guidance on the Target Development Profile Toolkit”
New and revised product-specific guidance from the FDA
The US Food and Drug Administration (FDA) has recently issued 36 new and revised draft product-specific guidances. These documents are published with the aim of fostering drug product development to increase public access to safe, affordable generic drugs. Read more “New and revised product-specific guidance from the FDA”
Health Canada’s guidance on electronic media in prescription drug labelling
In response to sponsors seeking authorisation to add extra information to prescription drug labels, Health Canada has released a draft guidance document detailing the agencies expectations on the use of electronic platforms to disseminate information on a prescription drug product. Read more “Health Canada’s guidance on electronic media in prescription drug labelling”
MHRA pilots patient involvement in new medicines applications
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a pilot project aimed at ensuring patient involvement in clinical trials and medicines development. Read more “MHRA pilots patient involvement in new medicines applications”
EMA releases further guidance on the control of nitrosamine impurities in sartans
Following the Committee for Human Medicinal Products (CHMP) Opinion on the presence of N-nitrosamines in sartans, the European Medicines Agency (EMA) has released a Q&A guidance document to aid manufacturers in implementing the CHMP Opinion. Read more “EMA releases further guidance on the control of nitrosamine impurities in sartans”
Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit
A combination of newly released and recently updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the requirements and procedures for the importing of medicines and devices into Northern Ireland (NI) following the end of the transition period. Read more “Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit”
EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’
One commitment in the Pharmaceutical Strategy for Europe highlights the need for fair and equitable access to healthcare for all. This latest pilot program has arisen as the European Commission (EC) aims to deliver on this commitment. Read more “EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’”