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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

Portugal and Spain strengthen collaboration with pilot project for the joint procurement of medicines

Patricia Carmona Botana

Last week, the Health Ministers of Portugal and Spain signed a letter of intent that marks the beginning of a joint procurement, funding and price negotiation initiative for medicines and medical devices in the Iberian region.  The initiative seeks to enhance cooperation in order to improve patients’ safety, patient’s access to innovative treatments, as well Read More