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”

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to sponsors seeking authorisation to add extra information to prescription drug labels, Health Canada has released a draft guidance document detailing the agencies expectations on the use of electronic platforms to disseminate information on a prescription drug product.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”

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”