Berlin (October 23, 2009) – The European Medicines Agency (EMEA) told industry manufacturing, control and regulatory professionals gathered at the 2009 PDA/EMEA Joint Conference that complicated supply chains, while necessary, are a weak link in quality control.
Opening plenary session speakers from the EMEA and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) outlined a number of interconnected challenges that are applying increasing pressure on the ability of both manufacturers and health authorities globally to safeguard the quality of pharmaceutical products.
Katrin Nodop, an EMEA Inspections Section representative, noted that the European Agency is working earnestly on partnerships with regulatory agencies in other regions to get a better grip on the growing challenges. One tool the EMEA uses is confidentiality arrangements, currently in effect with the U.S., Japanese and Canadian authorities. Nodop said, “Slowly, slowly our own priorities shift from the European perspective to the global one.”
To be effective in the future, the EMEA will seek methods of strengthening communication, collaboration and cooperation with industry and other health authorities. “We need to have proper arrangements so we can rely on the local regulators to do their work,” Nodop said in reference to countries like China and India which are now major suppliers of both active and inactive ingredients to drug manufacturers in Europe. The EMEA will “try to contribute to assist them through training and the exchange of staff to improve their regulatory capacity.”
Gerald Heddell, Director of Inspections, Enforcement & Standards, MHRA, UK, noted that changes in the economic environment and the escalating cost of R&D will only accelerate the trend towards outsourcing to India, China and other developing economies, about which he said, “I believe that many third country suppliers are responsible, well-managed companies, but recent experience reminds us that we need to be vigilant. And the further away, the more remote our sources of supply are, the more that vigilance is necessary.”
A number of other health authorities were represented at the two-day conference, including the Laboratoire National de Sante (Luxembourg), the Irish Medicines Board, the States Agency of Medicines (Latvia), the Agence Francaise de Securite Sanitaire des Produits de Sante (France), and the conference host country’s Regierungsprasidium Darmstadt.
The EMEA and PDA agreed to hold a fourth joint conference in 2011, following the 18-month schedule established at the first conference in 2006. The two organizations mentioned the possibility that the conference would become an annual event after 2011.