IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17

 

Inside this issue

     

IPEC Federation looks back on successful visit to China

The IPEC Federation spent a productive week in China over the summer, not only holding their latest board meeting in Beijing in mid-July but also taking the opportunity to participate in external events, including an educational workshop with the China’s Center for Drug evaluation and ExcipientFest Asia, for which the association was a co-sponsor.

The CDE workshop provided an opportunity for discussion on topics such as risk assessment and its role in the registration of excipients, the use of drug master files, regulatory inspection practices and supplier management programmes, amongst many other topics.Federation provided highlights insights on excipients regulation in US and Europe which included regulators’ expectations.

Meanwhile, IPEC was well represented in the ExcipientFest Asia programme: in addition to describing comprehensive overviews of the regulatory framework for excipients in Europe and the USA (with presentations from Patricia Rafidison, Dave Schoneker, and Priscilla Zawislak), the implementation of ICHQ3D in those regions and safety considerations for different types of excipients were presented by Janeen Skutnik-Wilkinson and Dave Schoneker, respectively, and Adrian Bne covered the topic of excipient auditing best practices.

It was an opportune time for the Federation to elevate its attention on China, particularly in light of ongoing regulatory developments at the China Food and Drug Administration (CFDA) and Chinese Pharmacopoeia (ChP), according to the association’s chair Patricia Rafidison.

“CFDA has joined ICH, and has an accelerated programme to revise regulations governing medicinal products and medical devices. It will be interesting to see how this impacts harmonization,” said Rafidison. “Of course, our hope is that efforts are taken to ensure China’s standards are in alignment with other ICH regions.”

She extended heartfelt thanks to IPEC China, saying the association’s close involvement “has been critical to be able to keep track of regulatory development in China and to facilitate a dialogue with users and suppliers of excipients there as well as the authorities.”

 

 

 

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