Behind Rx-360 Flash Reports: Keeping Members Current on Regulatory Developments

By Barbara Unger and Maureen Hardwick

The legislative, regulatory and policy framework related to supply chain integrity continues to evolve as regulatory agencies grapple with effective means to address counterfeit or adulterated components and drug products.   It is time-consuming and resource-intensive for pharmaceutical companies, and those that supply the pharmaceutical manufacturers with raw materials and components, to keep up – it takes a significant effort to monitor, identify, interpret and then communicate this information to their organization real time.  To address this need, Rx-360 created the Monitoring and Reporting Working Group soon after the organization’s inception in 2009.   

Providing Consistent and Timely Information

To provide as much value as possible to Rx-360 members, the Monitoring and Reporting Working Group first established processes and procedures to promote consistency within the work product and ensure the information is available soon after its release from the regulatory authorities.  Many members of the working group already perform this function within their member companies, which the working group is able to leverage.  Each member of the working group commits to prepare 2-4 work products annually.  Bi-monthly conference calls ensure alignment and clear communication of information.  As new publications become available from regulatory authorities, they are assigned to a team member to summarize.

Supply Chain Impact That’s Global and Fast   

The primary work product of the group is summaries of key regulatory developments with implication for supply chain integrity. The group takes a global perspective in their efforts and focus on legislation, regulations, and guidance for the pharmaceutical industry, both draft and final.  The goal is to publish summaries to Rx-360 members within 7-10 days after their release by regulatory authorities. 

The summaries, published as Flash Reports, include a brief introduction, a link to the document itself and a summary slide deck.  Often the documents address multiple areas, but we limit slide deck summaries to those areas with supply chain impact.  Interpretation is left up to each individual company to address.

“These summaries provide very valuable information that is easy to read and understand also by unfamiliar stakeholders within the complex supply chain. The provided flash reports are always comprehensive and focused and may serve as a tool to review, confirm or enhance companies Quality Systems,” explained Thomas Crispin of Bayer HealthCare.

“The flash reports (summary slides) are very useful to get a quick overview on the ‘burning’ topics, (e.g., Turkish GMPs, Saudi Arabia GMPs), which sometimes are difficult to get on time,” Ande Haeusermann of Novartis added.

The working group’s first summary was published in December of 2009.  The team published 24 summaries in 2010 and 22 summaries in the first 8 months of 2011.  The documents that have been addressed include:

• FDA Guidance for Industry Standards for Securing the Drug Supply Chain – Standardized Numerical Identification of Prescription Drug Packages

·         Brazil GMPs

·         US legislative proposal (HR4678) to create the Foreign Manufacturers Legal Accountability Act

·         China State Food and Drug Administration Provisions Regarding the Administration of Filing of APIs and Pharmaceutical Auxiliary Materials

·         USP <1079> Good Storage and Shipping Practices as published in the Pharmaceopeial Forum 37(4)

·         European Commission public consultation on the Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use

·         Republic of Turkey’s GMP/GDP Audit Guide

·         ECs Falsified Medicines Directive

Current group members include Barbara Unger (Amgen), Demetra Macheras (Abbott), Ruel Garcia (Watson Pharmaceuticals), Yvonne Stewart (GSK), Jeffrey Palmer (Merck), Gwyn Murdoch (Eli Lilly and Co.), Linda Evans O’Connor (Teva), Leah Michaels (Baxter), Karen Walker (Novartis), Renee Yancey (Cephalon) and Michael Montana (Temptime).  Debbie Armstrong and Maureen Donahue Hardwick of Drinker, Biddle and Reath, the Rx-360 Secretariat, also contribute significantly to the group’s ability to publish quickly and consistently.  

We welcome any suggestions readers might have for the group, please forward them to rx360info@dbr.com.