The European Medicines Agency (EMA) has released a draft version for consultation of its toolbox guidance for its Priority Medicines (PRIME) scheme. Read more “Draft toolbox guidance published for users of EMA’s PRIME scheme”
Category: Post-licence maintenance
Maintaining your product’s licence
EMA to provide new guidance on avoiding nitrosamine impurities in human medicines
After various animal studies were conducted, nitrosamines have been classified as “probable human carcinogens”. Read more “EMA to provide new guidance on avoiding nitrosamine impurities in human medicines”
Study finds an increase in safety related label changes for new drugs approved through the FDA’s expedited regulatory pathways
A new article that was recently published in the British Medical Journal found an increase in safety-related label changes in drugs approved through the FDA’s expedited pathway. Read more “Study finds an increase in safety related label changes for new drugs approved through the FDA’s expedited regulatory pathways”
EMA have released a new pre-submission variations checklist
A new pre-submission checklist has been published for Type II variations. The European Medicines Agency (EMA) has a handy set of checklists to help Marketing Authorisation Holders (MAHs) enhance the quality of their submissions for variations and renewals.
Read more “EMA have released a new pre-submission variations checklist”