For pharmaceutical organizations, understanding regulation and standards is critical to their success. GxP quality standards govern almost every aspect of drug development, from research to distribution.

As Track & Trace regulation spreads and evolves, understanding how regulation applies to each market is crucial. Failure to comply can mean a company cannot sell its goods in the market.

The introduction of serialisation requirements for the USA (via the DSCSA) came into force in November 2017, but the FDA deferred enforcement until November 2018 to allow companies more time to introduce the necessary serialisation measures. That deferment is now over and from November of this year (2018), serialisation is mandatory in the USA.

2019 is set to be a major year in the development of Track and Trace Regulation and will affect every pharmaceutical organization.

  • In February 2019, the EU FMD comes into force for the European market and its implementation is likely to have considerable impact on organisations as the system is used and is “bedded in”,
  • The Saudi SFDA announced very late in 2018 the introduction of regulatory reporting from 1/1/2019, an extremely aggressive timeline and it is doubtful that any Pharmaceutical manufacturer will be able to meet this deadline. Realistically we can expect some pragmatic response from the SFDA but we shall have to wait and see
  • The Russian Duma is currently debating 3 decrees that will result in the introduction of a far reaching and complex set of Serialisation and Track & Trace regulation for the Russian Federation. Meeting the Russian regulatory requirements will not be easy and will require careful thought; existing serialisation solution architectures may need significant modification to meet the Russian requirements and early engagement and planning will be needed.
  • In November of 2019, the next stage of the USA DSCSA act comes into force, introducing further requirements in the supply chain, and which is likely to result in additional requirements being imposed by the distribution companies within the US pharmaceutical distribution chain

In addition to the above, several countries have announced the introduction of serialisation regulations including:

  • Egypt have issued a decree and will introduce a wide ranging regulation,
  • We can expect an announcement from the Chinese CFDA on the systems/regulation to replace their currently suspended regulation,
  • Updates from Brazil,
  • Japan, Qatar, Pakistan, UAE, Oman, Iran, Taiwan, Egypt, Jordan, Serbia, Ukraine and Vietnam are all introducing regulations.

Knowing the regulation and understanding its use is mandatory for any pharmaceutical organization. This is not a “one-off” exercise and regulation is not static. Within the Track & Trace world, we have seen major changes to the various regulatory regimes. Keeping on top of the regulatory requirements is an ongoing necessity.

How Movilitas can help

Movilitas have more experience in the pharmaceutical Track & Trace world than any other solution supplier. We can provide services based on years of experience and will work with you to ensure that your organization understands and can fulfill its regulatory obligations.

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Get in touch with us

Europe

Marco Steinkamp
Sales Director Track & Trace
Movilitas Consulting GmbH
+49 621 150204 0
+49 175 4575967
marco.steinkamp@movilitas.com

North America

Robin Teiner
Track & Trace Sales North America
Movilitas Consulting LLC
+1 800 359 1712
+1 872 600 6306
robin.teiner@movilitas.com