The EMA suggests that asking drugmakers to conduct risk assessments of manufacturing processes and supply chains could help prevent shortages.
The idea is one of a number of measures put forward in a concept paper in which the European Medicines Agency (EMA) discusses the shortages that have struck the drug industry in recent years.
While the EMA acknowledges that lengthening global supply chains – which mean the actives for many drugs are now sourced outside Europe – coupled with consolidation of the manufacturing services sector – which is limiting the number of suppliers – played a significant role in recent shortages, it still believs the drug industry needs to do more.
“The [pharmaceutical] industry’s risk management tends to be very reactive rather than proactive. Sustained pressure is needed to bring about a change in a manufacturer’s approach to quality risk management and supply chain security.”
At present EU legislation requires mandatory prenotification of disruption of supply in the case of permanent or temporary cessations and for manufacturers of medicines in the case of any defect that could lead to an abnormal restriction in supply.
The agency suggests that instead requiring drugmakers to submit a risk-analysis of their manufacturing process would identify any weaknesses and, depending on the severity, allow firms to develop a contingency plan and proposals to strengthen the identified weaknesses.
It also points out that such a move would be in keeping with measures taken elsewhere.
“In the US, as a result of a high number of shortages of medicinal products, the Food and Drug Administration (FDA) have published at the end of last year a draft “Interim Rule” regarding revised mandatory prenotification requirements for manufacturers in case of potential drug shortages."
The EMA also puts for the idea of developing a catalog of drugs that have been hit by supply problems that would include data provided by drugmakers on shortages caused by manufacturing and or GMP compliance problems.