The current situation in the pharmaceutical industry
With the goal of fighting the immense market of counterfeit products, several initiatives and legislative measures have been taken or are in the process of being implemented around the world, especially in the pharmaceutical industry.
Initiatives by region/country
EU: Falsified Medicine Directive (FMD) 2011/62/EU for prescription drugs and over the counter (OTC / nonprescription) drugs that may be subject to counterfeiting, to be implemented by Q4 2018.
USA: Drug Quality and Security Act (DQSA) as well as the Drug Supply Chain and Security Act, with an implementation milestone timeline set until 2023.
China: eCode (barcode) by China Food and Drug Administration (CFDA…formerly SFDA).
Turkey, India, Brazil, Australia, others: Various legislations are in place or in preparation.
More information
On Falsified Medicine Directive 2011/62/EU please download the 'Product Traceability' whitepaper.
On general regulations (FDA, HACCP, GMP, etc.) please visit our regulations webpage (tcm:502-31119).