European Medicines Agency provides plan to help deal with manufacturing-related medicine shortages
The European Medicines Agency has published a plan to help the European medicines regulatory network deal with supply shortages of medicines following manufacturing problems.
Published today, the reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice (GMP) compliance problems summarises the lessons that the Agency has learned from previous crises where it played a supporting or coordinating role. It provides a short and medium-term plan to help the European medicines regulatory network prevent, mitigate and manage shortages of important medicines.
The occurrence of shortages of medicines has increased over the last few years. The paper identifies the globalisation of manufacturing and supply chains as a major contributing factor to the occurrence of supply shortages. It also includes a number of activities to encourage more active risk management by the pharmaceutical industry, reducing the vulnerability of supply chains.
The reflection paper was developed by the Agency in collaboration with the European medicines regulatory network, including the European Commission and regulatory authorities in the European Union (EU) Member States.
The Agency plays a key role in the harmonisation and co-ordination of activities related to GMP in the EU. It is involved in coordinating the preparation of new and revised guidance on GMP, coordinating advice on the interpretation of EU GMP requirements and related technical issues, and developing EU-wide procedures relating to GMP inspections.