Albumedix Ltd. (‘Albumedix’), the world leader in recombinant human albumin (rHA), announced the submission of Drug Master Files (DMFs) to the Pharmaceutical and Medical Device Agency (PMDA) in Japan.
Albumedix has submitted DMFs for two of their products in order to further support customers in Japan. The DMF system allows manufacturers, such as Albumedix, to submit detailed confidential manufacturing, chemistry and controls information of their product to PMDA to provide assurance to the regulator that the product is safe, effective and of an appropriate quality for customers to use in their final products. The registered information is necessary for inclusion in applications for pharmaceutical products in which Albumedix products are used.
“Albumedix submits Drug Master Files for its products in Japan.“
With these DMF submissions, alongside the enhanced regulatory customer support that Albumedix is able to offer customers, the review process for the customers’ end product is made considerably less onerous and assures both the customer and regulators that Albumedix can provide robust and comprehensive documentation, helping customers to alleviate the regulatory burden of product development.
As a non-Japanese company, Albumedix are also required to apply to be accredited by the regulator as approved foreign manufacturers, a process which has also been progressing ahead of the DMF submissions.
Commenting on the DMF submissions in Japan, Albumedix Director of Global Regulatory Affairs Harriet Edwards says, "These submissions are a continuation of Albumedix strategy and ethos; we are dedicated to supporting our customers in all aspects of their product development and beyond when using our products in order to become the partner of choice for advanced therapies worldwide. We are extremely happy to add to the support we currently provide our customers in Japan and believe the submissions further confirm our intent to fully serve the Japanese market. This is a market we have had a presence in for many years and which is currently expanding, especially due to the advance of cell and gene therapies in this territory. The submission of the DMFs in Japan allows Albumedix to provide an enhanced level of regulatory support to these customers as well as an increased assurance of our product safety and quality, particularly for those in clinical development and heading towards commercialisation"See all the latest jobs in Pharmaceutical