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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

China: Update on IP and regulatory developments

David Shen

The Chinese Food and Drug Administration (CFDA) recently released a number of new guidelines and regulations to implement the directives from the Central Government Opinion released on 8 October 2017 (see our earlier post: Chinese medicinal product approval reform announced). These new guidelines and regulations represent the efforts made by CFDA to promote innovation in the Chinese Read More

Chinese medicinal product approval reform announced

David Shen

The Chinese central government rolled out a 36-points reform plan for Chinese medicinal products and medical devices approval system on October 8. Notably, China will adopt a US style patent linkage system including an automatic stay for patent challenge, start a pilot program for patent term extension and encourage patent challenges by generics.  This will Read More