On 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK will be the first country in the world to introduce a tailored framework for the manufacture of innovative medicines at or close to the
Latest from BioSlice Blog - Page 13
Landmark Whistleblower Program for China’s Healthcare Sector
On October 10, 2024, the National Medical Products Administration in China released the Draft Rule on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices (the Draft Rule) for public comment, due by
UK government launches new Industrial Strategy and Advisory Council to boost economic growth
On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving
Virtual and Digital Health Digest – October 2024
This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.
Guidance on AI continues to be published. In the EU, the European Medicines Agency
European Parliament resolution on need to revise the Medical Devices Regulation
On 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
This resolution acknowledges that the MDR and IVDR were adopted to strengthen the
China’s First Official Anti-Corruption Guidance for the Healthcare Industry
On October 11, 2024, the Chinese State Administration for Market Regulation (SAMR, 国家市场监督管理总局) issued the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Draft Guidelines, 医药企业防范商业贿赂风险合规指引). These Draft Guidelines were published for public comment, due by
UK government launches new Regulatory Innovation Office to reduce red tape
On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology
EMA adopts reflection paper on the use of Artificial Intelligence (AI)
Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July
A New 2024 Code for the British Pharmaceutical Industry – “The Future is Orange”
On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI
Virtual and Digital Health Digest – September 2024
This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.
There have been some important reimbursement updates this month. In France, the French health regulator has