Collaborating to Protect the Supply Chain from Counterfeiters - Pharmaceutical Technology

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Collaborating to Protect the Supply Chain from Counterfeiters
Adeline Siew PharmTech speaks to Lynne Byers and Brian Johnson about Rx-360's initiatives to protect patient safety.


Pharmaceutical Technology
Volume 36, Issue 12

PharmTech: What would you identify as the key provisions on the EU FMD or the US FDASIA in addressing supply-chain security? How can regulators better harmonize efforts globally?


Brian Johnson
Byers: In terms of improving supply-chain security, the key provisions of the FMD are as follows. All active substances, or APIs imported into the EU, will be required to be manufactured in compliance with GMP equivalent to those of the EU by Jan. 2, 2013. Written confirmation of compliance with this requirement, which will be issued by an authority in the exporting country, will need to accompany all active substances imported into the EU as of July 2, 2013. Exporting countries may apply for an exemption to these rules, but no country has been granted an exemption to date. In exceptional circumstances, and where necessary to ensure the availability of medicinal products, if the API manufacturing facility has an EU GMP certificate, then a member state may waive the requirement for written confirmation for a period not exceeding the validity of the GMP certificate. Member states that make use of the possibility of such waiver shall communicate this to the European Commission. The first country has just been granted an exemption from the written confirmation requirements—Switzerland. The process, which is to be used by each member state's regulatory authority, has not yet been communicated. In terms of regulators working more closely together, the mutual recognition of inspection reports is encouraged because this will help regulators to inspect more facilities.

Johnson: Collectively, the recent legislation in the US and EU will help enhance supply-chain security but we need similar legislative initiatives in other regions of the world to level the playing field. Our supply chains are complex and global, and because the weakest link is what criminals will exploit, global harmonization is critical. We are heading in the right direction with initiatives by regulators to collaborate on auditing, information sharing, and risk analysis. Other stakeholders are collaborating through organizations such as Pharmaceutical Cargo Security Coalition (PCSC), Pharmaceutical Security Institute (PSI), and Rx–360. It is hard to single out specific provisions of legislation, regulations, or efforts by specific organizations because they all contribute in different ways and attack different aspects of the problem. The key will be continued collaboration and avoiding working in silos, which we tend to do sometimes.

PharmTech: Could you provide an update on Rx–360's initiatives and activities thus far in 2012 and its focus of activity for 2013?

Byers: Firstly, as a consortium, we are enhancing and facilitating joint and shared audits. Both audit programs are operational following a period of piloting. Secondly, we are also addressing a broader range of supply-chain security topics. A new supply-chain security group was established and has developed and shared best practice documents. Thirdly, we are actively engaging regulators and educating legislators. In terms of communications, we have organized webinars around many Rx–360 initiatives. We have also produced 326 news flash reports and process for industry wide messaging, 90 summaries of proposed or passed regulation or legislation with an average time to publish between 6–10 days, 16 newsletters and conducted 4 open meetings.

For 2013, we have targets to increase membership in all categories and to continue to work on our priorities of the audit programs, supply-chain security and analysis, and swift dissemination of supply-chain security information.

PharmTech: To date, what are the three biggest achievements accomplished by Rx–360?

Byers: I would say that our three biggest achievements are: global collaboration between manufacturers and suppliers within the organization; a positive opinion from the Federal Trade Commission (FTC) that the audit programs, if operated as described to the FTC, are unlikely to breach US anti-trust laws; and our ability to pull together world experts to work on a problem within a tight timeframe (e.g., following the tsunami in Japan).


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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