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EMA publishes drug shortages plan

Globalisation of manufacturing among key issues to address

The European Medicines Agency (EMA) has published a plan to help the EU network of national regulators deal with shortages of medicines due to manufacturing problems.

The regulatory body said the paper “summarises the lessons that the Agency has learned from previous crises where it played a supporting or coordinating role”, and provides both short- and medium-term plans to both prevent and manage medicines shortages on a pan-European level.

The problem has become an increasing issue in recent years, according to the EMA, with globalisation of manufacturing and supply chains cited among the main reasons for deficient supplies of pharmaceutical products.

“Many sources of active substances for life-saving medicines, eg antibiotics, are now wholly located outside the EU, some located in countries that have uncertain political and regulatory systems and which may be prone to natural disaster,” said the report, which referenced the 2011 tsunami in Japan as an example of a disaster impacting on the medicines supply chain.

Ongoing problems at the Ben Venue manufacturing plant in Ohio were also mentioned by the EMA, with a voluntary shutdown at the facility leading to a shortage of Johnson & Johnson's cancer drug Caelyx/Doxil (doxorubicin) in both Europe and the US.

Other issues noted by the EMA included the industry's response being reactive rather than proactive, where manufacturers need to change their approach to risk management and supply chain security in order to prevent problems before they have a chance to occur.

In addition, the EMA said the “regulators' dilemma” needed to be addressed, with some defective medicines left on the market as there was no alternative available, and the risk of patients taking no medicine was greater than taking defective medicine.

To overcome these challenges, a series of actions to be implemented between now and 2015 has also been published by the EMA.

Short-term plans include establishing an internal catalogue of centrally authorised products (CAPs) and non-CAPs that have experienced product shortages in order to analyse trends.

A common understanding of what constitutes an “essential” medicine also needs to be developed to determine what shortages needed to be prioritised at EU level, while international co-operation should be encouraged so that there is a sharing of information on specific shortages.

Medium-term actions include a requirement for all pharma companies to submit a risk-analysis of their manufacturing process, which should identify any weaknesses and, depending on the severity, provide a contingency plan and proposals to strengthen the identified weaknesses.

28th November 2012

From: Regulatory



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