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China announces pilot scheme for pharmaceutical tendering with minimum procurement quantities

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

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

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

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

Commission closes infringement proceedings against Poland, Romania and Slovakia relating to parallel trade of medicines

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