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China: Update on IP and regulatory developments
28 February 2018 - Posted by: 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
14 November 2017 - Posted by: 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
Falsifying drug regulatory submission may be a criminal offence in China
28 August 2017 - Posted by: David Shen
In China’s latest effort to limit substandard drugs being approved using falsified clinical and non-clinical data, the Supreme People’s Court and the Supreme People’s Procuratorate jointly issued Judicial Interpretations that expressly provide that falsifying a drug regulatory submission may be a criminal offence which can be sanctioned with a penalty of up to 10 years imprisonment. The › Read More
Human Germline Genome Editing – Genetics bodies weigh in on debate with position paper
11 August 2017 - Posted by: Daniel Lim
In an article published in American Journal of Human Genetics on 3 August 2017, an international group of 11 organisations with genetics expertise has issued a joint position statement, setting out 3 key positions on the question of human germline genome editing: At this time, given the nature and number of unanswered scientific, ethical, and › Read More
BeneluxA collaboration joint pricing negotiations fail
25 July 2017 - Posted by: Eveline Van Keymeulen
The first joint pricing negotiations for a medicinal product in the context of the BeneluxA collaboration with respect to health technology assessment and pricing and reimbursement have failed. On 23 May 2017, the Belgian Minister of Health announced that the Belgian National Institute for Health and Disability Insurance (RIZIV), joined by the Dutch competent authorities, › Read More