How authorities and enterprises are reinforcing the safety of the pharmaceutical supply chain

As recent years have shown, falsified medicinal products and sub-standard raw materials are a big problem in today's globalized pharmaceuticals market. After all, the reputation of suppliers and producers – and more important still, patient safety – depends on their ability to guarantee the quality and efficacy of the products they produce. The time has now come for authorities to react with new regulations. Both the EU Medicrime Convention and the Falsified Medicines Directive are steps in the right direction.

The Falsified Medicines Directive took effect on July 21, 2011. It aims to prevent falsified medicines from entering into the legal supply chain. For the first time, the new directive requires pharmaceutical manufacturers to perform a formalized risk assessment for excipients used in the pharmaceutical manufacturing process to assure appropriate GMP.

The higher level of safety means extra work for all involved stakeholders, but assures patient safety. This is why it's sensible and important for the pharmaceutical industry to take the initiative with the Rx-360 consortium or EXCiPACT™, to deal with the new regulations more efficiently. Only by pulling together can the authorities and our industry achieve their mutual goal of sustainable protection for companies and patients alike.

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