EMA 'road map' outlines supply chain security plans

The latest five-year plan from the European Medicines Agency (EMA) makes specific reference to a number of supply chain security elements, with a greater emphasis on counterfeiting and substandard ingredients than earlier documents.

Outlining the agency's strategy for the 2010-2015 period, the document says the overall objectives are to protect public health, improve the regulatory environment for medicinal products and stimulate innovation in the EU. It is up for public comment until April 30, 2010.

Among the elements most relevant to supply chain security, the EMA highlights the impact of increasing globalisation of the pharmaceutical industry, and particularly "the increasing manufacture of active pharmaceutical ingredients (APIs) outside the EU, and in particular the potential for substandard material to enter the supply chain."

The EMA's strategy document gives a nod to the ongoing developments at the European Commission, Parliament and Council in the area of substandard active substances and counterfeiting, while noting that "the issue will remain high on the political agenda until implementation of the new legislative proposals."

The EC proposed a new anti-counterfeiting directive in the pharmaceutical package unveiled in December 2008, and a report from the European Parliament's rapporteur, which recommends a number of amendments including an extension of the proposals to include excipients and medicines bought on the Internet, is on the table.

The EMA says its own priorities are to assess its preparedness mechanisms to see if they need revision, and to carry out a 'lessons leant' exercise after each major event to continuously improve its handling of substandard and counterfeit drugs.

Other measures to supply chain security include boosting the capacity for inspections of API and finished product facilities with international regulatory partners.

Once the public consultation period is completed the EMA says it will develop a second document, 'From Vision to Reality', that will lay out the operational aspects of implementing the road map.