Raising the Standards of Pharmaceutical Excipients – Back from the IPEC Forum17 Feb 2020
Albumedix attended the International Pharmaceutical Excipients Council (IPEC) Annual Forum and AGM in Aix-en-Provence, France earlier this month. The Annual Forum is a key event for pharmaceutical excipient experts and pharmaceutical manufacturers across Europe, bringing together excipient producers, distributors and members of the pharmaceutical industry to promote quality excipients for use within pharmaceuticals, contributing to improved safety, compliance and efficacy of medicines. From the production of internationally recognized and harmonized guidelines to raising awareness and standards of pharmaceutical excipients, IPEC are a critical influencer and key voice for the industry with regulators, finished product manufacturers and excipient users. In addition to the usual agenda for the Annual Forum, IPEC was also celebrating 10 years of the IPEC Federation, harmonizing IPEC Europe, Americas, China and other regions.
Albumedix has been an active member of IPEC for many years, sitting on the Quality and Regulatory Affairs Committee and contributing frequently to the initiatives driven by this sub-committee within the council. This year was no exception, with the QRAC discussions featuring a proposal for the introduction of EU DMFs. This is something that Albumedix, together with other IPEC members have provided as an official position paper to be used as a point of discussion with EU regulators, in the hope that they may consider the introduction of a DMF system for pharmaceutical excipients, similar to that already in existence across other major territories such as the US, China and Japan.
As the second largest pharmaceutical market in the world, a heavy focus of the Forum was the regulatory reform in China and what this mean specifically for excipient producers. Updates to relevant regulatory legislation and guidance were comprehensively presented by key opinion leaders, with a particular focus on the registration of excipient DMFs and what to expect during the Bundling Review Process. This is a particular area of interest for Albumedix having recently filed a DMF with CDE in China for Recombumin®.
Now, back from IPEC and reflecting on the meeting, we are excited about the efforts already being made to increase standards of pharmaceutical excipients. We're looking forward to the future possibilities on this topic!