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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

Falsifying drug regulatory submission may be a criminal offence in China

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

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

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