Home / Biosimilars / News / Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system

Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system Posted 14/06/2019

Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the recently introduced Quality Consistency Evaluation (QCE) system.

Sandoz is the first multinational pharmaceutical company to receive approval for a generic drug under the QCE system. The QCE system is an extensive set of health system reforms introduced by the government in China over the last few years which aim to ensure that all generic medicines marketed or manufactured in China meet internationally recognized quality standards. The reforms also offer the potential to significantly reduce the timeframe for registration of generic medicines in China.

Sandoz plans to submit further generics applications in China, focussing specifically on areas of greatest unmet need.

According to Francesco Balestrieri, ad interim CEO at Sandoz: ‘This first-of-a-kind generic approval for a multinational company demonstrates our strategic focus on pioneering access to high quality medicines in China, which is the world's largest generics market and offers enormous future potential to address unmet needs, particularly in the area of chronic diseases’.

Mr Balestrieri added: ‘Specifically, this regulatory milestone helps to pave the way for Sandoz to compete in future generic drug tenders in China, as the evolving tender system increasingly moves to favour QCE-approved molecules. We see great potential to grow long-term in China and have the commitment and capabilities to succeed, including programs to conduct R & D and clinical development in China, specifically for the Chinese market’.

Related articles
Sandoz makes biological deal in China

Chinese guidelines for copy biologicals

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Comments (0)