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China announces pilot scheme for pharmaceutical tendering with minimum procurement quantities
05 December 2018 - Posted by: David Shen
On 15 November 2018 the Joint Procurement Office (JPO) published its Paper on Centralized Drug Procurement in “4+7 Cities” (the Paper) which launched the national pilot scheme for tendering with minimum procurement quantities. The pilot scheme will be carried out in 11 cities: Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xian, › Read More
China – Data compliance in the life sciences sector
15 November 2018 - Posted by: David Shen
China’s Ministry of Science and Technology (MOST) recently announced administrative sanctions against six entities for breach of the Provisional Measures for the Administration of Human Genetic Resources (Measure). In the 20 years since the Measure was implemented, this is the first time that MOST has announced any enforcement action. A closer look at the MOST › Read More
China’s new anti-bribery agency announces pharma probe
31 May 2018 - Posted by: David Shen
China’s State Administration for Market Regulation (SAMR) has announced the launch of a nationwide campaign to crack down on unfair competition and commercial bribery in the pharmaceutical, medical device and educational sectors. The campaign comes at a time when the Chinese government has enacted key amendments to its Anti-Unfair Competition Law (AUCL) and is gearing › Read More
FDA announces suite of guidance documents to facilitating development and approval of gene therapies
23 May 2018 - Posted by: Daniel Lim
On 22 May 2018, FDA Commissioner Scott Gottleib gave an address at the Annual Board Meeting of the Alliance for Regenerative Medicine. The wide ranging speech focused on the promise of cell and gene therapies and the challenge that such new technologies present to the existing regulatory frameworks for development and approval. The key takeaways › Read More
22 May 2018 - Posted by: Juraj Gyarfas
On 17 May 2018, the European Commission announced that it had decided to close its infringement procedures and the treatment of complaints related to parallel trade of medicines for human use against Poland, Romania and Slovakia. By way of background, parallel trade has long been a major concern for both governments and pharmaceutical companies in › Read More