Regulatory Focus™ > News Articles > Italy Faces Regulatory Hurdles After Earthquakes Slam Life Science Industry

Italy Faces Regulatory Hurdles After Earthquakes Slam Life Science Industry

Posted 05 June 2012 | By Alexander Gaffney, RAC 

It's an ongoing challenge for companies to get products and manufacturing facilities approved by regulatory authorities-and that's before natural disasters strike, potentially leaving their research and manufacturing facilities in ruin.

For Italy's life sciences industry, this potential has taken on a disturbing reality after a series of earthquakes in Mirandola, Italy have threatened to shut down the entire sector, reports Reuters. The region has suffered economic damage in the estimated range of €2-5 billion, with more damage possible as a series of powerful aftershocks continue to hit the region.

The damage is particularly serious for Italy's biomedical sector, which is largely headquartered around Mirandola. Local officials, including Mayor Giorgio Pighi, fear the companies "could suffer at the hands of foreign competition."

Many companies are unable to enter their manufacturing facilities due to fears of structural instability, and supplies may have to be discarded after suffering potential power disruptions or damage in the quake.

Some manufacturers, including Artech, a medical device manufacturer, have suffered such extensive damage to their facilities that they will need to be pulled down. Still others are working frantically to re-route supply chains and avoid Mirandola for the time being in the hopes of minimizing disruptions.

The supply chain disruptions also have the potential to cause drug and device shortages in Italy, which is already suffering shortages after delaying payments to many pharmaceutical companies and slashing reimbursement amounts as part of austerity measures.

Even after facilities are reconstructed or brought back online, regulatory hurdles may encumber the companies. Because the facilities might be classified as new, they would likely require extensive inspection by the European Medicines Agency (EMA) and other foreign regulatory authorities before being allowed to resume shipments. Even facilities not totally destroyed will still require extensive preparations by regulatory staff to bring them back into compliance with regulations before they can be brought back online and resume production.

Read more:

Reuters - Quake risks are crippling Italy's biomedical industry

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