Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|May 17, 2023
EMA Guidance Looks to Prevent Drug Shortages
Author(s)Susan Haigney
The agency has published guidance on good practices for securing the supply of medicines.
Advertisement
On May 17, 2023, the European Medicines Agency announced it has published a guidance document that recommends good practices for securing the supply of medicines and preventing shortages. The document discusses the stakeholders involved in the supply chain and their responsibilities in preventing drug shortages. There are 10 recommendations for minimizing drug shortages. These are:
- Informing national competent authorities of potential and actual shortages
- Establishing prevention and shortage management plans
- Optimizing quality systems
- Communicating with supply chain stakeholders
- Promoting fair and equitable distribution of medicines.
“Medicine shortages are a global health problem and are increasingly affecting European countries. Shortages can lead to medicine rationing and delay in critical treatments, with a significant impact on patient care. In addition, patients may need to use less effective alternatives and face an increased risk of medication errors. Ensuring the availability of authorized medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network,” the agency stated in a press release.
Source:
Advertisement
Related to this article
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Advertisement
Advertisement