EMA regulation and response to drug shortages

EU drug shortage search

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/availability-medicines/public-information-medicine-shortages#ema-shortages-catalogue-section 

The relevant information published by EMA, retrieved at the above URL, is divided into: Ongoing shortages and Resolved shortages.

By verifying the information, there are currently 43 drugs on the EMA published list that are in shortage as of April 2023.

To search for information on drug shortages in EU member states, please click on the following addresses and links:

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/availability-medicines/public-information-medicine-shortages#national-registers-of-shortages-section

Management response agencies

The EMA has established an agency called the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address drug shortages.

For more information on the organization and responsibilities of the MSSG, please refer to the following website:

https://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steering-group-shortages-safety-medicinal-products 

How MAH reports drug shortages?

According to the EMA website, MAH can report drug shortage information and other urgent information through the industry's single point of contact (i-SPOC).

Guidelines issued by EMA and dealing with drug shortages

---《Good practice guidance for communication to the public on medicines’ availability issues》；

---《Criteria for classification of critical medicinal products》

---《Decision tree on escalation from national to European level》

---《Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects》

---《Closing report on assessment of a supply shortage of a medicinal product due to manufacturing and quality problems》

---《Resources for issuing treatment recommendation during shortages of medicinal products》

---《Risk indicators for Shortages (Manufacturing and Quality)》

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.