The Administration for Market Regulation of Shanghai recently finalized penalties totaling RMB 223 million (approx. $31 million) against three pharmaceutical companies for colluding to fix prices and divide markets for...more
China’s main healthcare regulatory bodies, including the National Medical Products Administration, released draft administrative measures for pharmaceutical representatives intended to strengthen anti-corruption efforts and...more
China’s National Medical Products Administration (NMPA) on November 13, 2024 issued the Interim Provisions on the Administration of the Domestic Responsible Person Designated by Foreign Marketing Authorization Holders (New...more
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
In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more
The Shanghai Municipal Health Commission—with the Shanghai Municipal Medical Insurance Bureau and the Shanghai Municipal Administration of Traditional Chinese Medicine—issued a new regulation on April 7, “Implementation Rules...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
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
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
In an effort to increase the availability of pharmaceutical treatments in China, the China National Drug Administration has recently released guidelines to allow pharmaceutical drugs that have already undergone clinical...more