The Shanghai Health Commission, together with 13 other governmental authorities in Shanghai, jointly published on October 10, 2024 the Shanghai version of the 2024 Notice on Issuing the Key Points of Correcting Improper...more
Inventive deal structures are on the rise within China’s life sciences industry, with the “NewCo” model having garnered significant interest among Chinese pharmaceutical companies in recent years. In 2024, several landmark...more
With the consequences of the global pandemic still reverberating throughout the Asia-Pacific region, governments and businesses in the area continue to focus on the life sciences industry. From startups to global...more
China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more
6/6/2023
/ Biotechnology ,
China ,
Compliance ,
Export Controls ,
Genetic Materials ,
Genetic Testing ,
Healthcare ,
Life Sciences ,
Multinationals ,
Pharmaceutical Industry ,
Popular
In the midst of a significant increase in foreign direct investment (FDI) in the US life sciences industry, which includes medtech and biopharmaceutical companies, Chinese FDI has declined considerably since its peak year of...more
Multinational pharmaceutical companies, by nature of their business, handle a great deal of data, often transferred across borders, whether based on research, clinical trial data, and employee personal data....more
10/11/2021
/ China ,
Clinical Trials ,
Cybersecurity ,
Data Controller ,
Data Processors ,
Data Protection ,
Data Security ,
Genetic Materials ,
International Data Transfers ,
Life Sciences ,
Multinationals ,
Personal Information Protection Law (PIPL)
Life sciences companies are increasingly global, with the nationalities of individuals in management teams and offices often spanning the major life sciences centers across the United States, in China, and around the world....more
China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more
The Chinese government has been actively promoting internet-based medicine in mainland China since 2014. On July 17, 2018, the National Health Committee (NHC) and the State Administration of Traditional Chinese Medicine...more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
In an effort to drive down medical costs, the PRC Ministry of Finance has announced it will audit 77 randomly selected drug makers in China in order to examine the companies’ costs and profits and determine the reasonableness...more
The Administration for Market Regulation of Jing’an District in Shanghai (AMR) on May 7 announced an administrative penalty decision against the Shanghai branch of a multinational pharmaceutical company (the Branch) for...more
Expanding on recent reforms allowing innovative pharmaceutical drugs to be approved on the basis of overseas clinical trial data, China’s National Medical Products Administration (NMPA) has created special channels for the...more
The release of the rare diseases list, along with the allowance of foreign clinical data in new drug applications, is expected to substantially shorten the timeline and streamline the process for the approval of new orphan...more
On March 17, 2018, China’s National People’s Congress (NPC) approved a general plan proposed by China’s State Council to restructure certain Chinese government agencies. This restructuring plan affects a wide range of Chinese...more
The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more