On June 25, 2018, the Chinese Ministry of Justice announced amendments to the Supervision and Administration of Medical Devices Regulations (the Regulation) and called for public comment. The proposal is being celebrated by a variety of stakeholders across the medical device and IVD industry following years of lobbying to have the Regulation amended. However, some apprehension regarding the implementation of the proposed Regulation remains.
Read the full document here: BHA China Medical Device IVD Policy Update – Proposed Regulations, 6.28.2018 (FINAL): PDF
While establishing payment mechanisms is an important part of the DTx value realization chain, creating a clear and differentiated value proposition and an effective value communication strategy are critical, precursive steps to value monetization.
An official statistical report of the 2018 national social health insurance fund, which provides high-level data for an outsider to try to grasp the essential characteristics of China’s healthcare funding and delivery system and understand the challenges an industry player as well as the Chinese government payer are facing...
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA evaluated a total of 166 Dossiers - 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations.