Pharmaceutical companies and wholesalers will have to meet more requirements in terms of reporting medicine supply disruptions, and there will be a greater focus on the use of joint procurement in the event of shortages, if amendments made to the EU pharma reform by the European Parliament last month are backed by the member states.
EU Pharma Reform Amendments: More Shortage Reporting Obligations For Companies & Regulators
In the third of a series of articles on the European Parliament’s changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors.
More from Europe
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
• By
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
More from Geography
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.