Update from the Pistoia Alliance’s Controlled Substance Compliance & Shipping Expert Communities (CSCS)
March 11, 2022: Legislation is changing rapidly, and it has become much more complex to stay compliant. To assist its members, the CSCS Expert Communities provide a forum for compliance professionals, researchers, compound and shipping managers to share best practices and update their awareness of new legislation. The expert communities are made up of major pharmaceutical companies and specialist software providers.
Birthe Nielsen, CSCS community manager, explains that “meetings for each community are attended by members spread across Europe and North America with input from time-to-time from members in other important regions providing the group with know-how from across the globe. We usually have representation from around 15 different companies.”
Recent meetings in the CSCS expert communities have included updates on the INCB GRIDS program by the INCB secretariat, supporting members in responding to global-scale problems associated with the illicit drug market which has witnessed rapid changes in recent years. Sophistication and innovation in illicit drug manufacturers have increased the use of non-scheduled chemicals and designer precursors, and a greater focus on materials and equipment essential for illicit drug manufacture.
The CSCS Expert Community continues to focus on the evolving controlled substance regulations around the world that impact the member groups, particularly in the research space. The group has facilitated the creation of systems that are used today by governments and top pharma companies to look up the controlled status of a chemical structure across multiple countries and for alerts on new legislation.
Through discussion and collaboration with expert external speakers and with independent and quasi-judicial monitoring bodies such as the INCB, the CSCS Expert Community is a forum to increase awareness and share best practices on controlled substance regulations in pharma R&D.
Jessie Bin Song (Merck), Chair of the CSCS Expert Community says, “Controlled Substance legislation and regulations are changing rapidly as legislators respond to the issues and concerns in society. We can no longer single-handedly keep up with the changes. Collaboration within the pharmaceutical industry and across with regulators is the way to go, coupled with modernized tools to assist in making scientifically sound and regulatory-compliant decisions.”
The latest addition to the CSCS Expert Group is the Shipping Expert Group, with the latest meeting delivering an overview from Scitegrity on the changes to the harmonized system (HS) nomenclature which became effective in January 2022. In addition, the group held a round table discussion around BREXIT and the significant changes to the UK government regulations rolled out since December 2021.
Jack DeCicco (GSK), chair of the Shipping Expert Community reports that “many of our members are facing challenges relating to import, in particular from Northern Ireland to the UK. Sharing of good practice and procedures within the group provides unique opportunities to overcome such barriers much faster.”
To join Controlled Substance Compliance & Shipping Expert communities, please get in touch with Birthe.Nielsen@PistoiaAlliance.org or send an email to ProjectInquiry@PistoiaAlliance.org to get involved.
About the Pistoia Alliance
The Pistoia Alliance is a global, not-for-profit members’ organization made up of life science companies, technology, and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D. It was conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis and Pfizer who met at a conference in Pistoia, Italy. Its projects transform R&D through pre-competitive collaboration. It overcomes common R&D obstacles by identifying the root causes, developing standards and best practices, sharing pre-competitive data and knowledge, and implementing technology pilots. There are currently over 150 member companies; members collaborate on projects that generate significant value for the worldwide life sciences R&D community, using The Pistoia Alliance’s proven framework for open innovation.