Mondaq All Regions - China: Food, Drugs, Healthcare, Life Sciences
Ropes & Gray LLP
China will launch further reforms in the pharmaceutical sector as part of the healthcare reform initiatives announced by the State Council in its February 9, 2017 Circular on Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage (the "Circular No.13").
Han Kun Law Offices
Can foreign investors set up wholly-owned medical institutions in China? This is a question that clients constantly ask when entering the Chinese healthcare industry...
Jun He Law Office
Last year ushered in an abundance of new laws and regulations for the pharmaceutical industry in China. Various pharmaceutical policies, including national laws and regulations as well as local supporting policies such as the dual-invoice system, . . .
Han Kun Law Offices
As mentioned in Study on Foreign-Invested Medical Institutions (I), although China had at one time implemented a pilot program for establishing wholly foreign-owned hospitals, current policies prohibit full ownership.
Jun He Law Office
In early 2016, the Price Supervision and Anti-monopoly Bureau of China's National Development and Reform Commission issued the article "Key Issues on Price Supervision and Anti-monopoly in 2016" . . .
Han Kun Law Offices
With the continuous development of cloud computing and internet of things technology, the internet is further reshaping the healthcare industry.
Ropes & Gray LLP
The Revisions would standardize the conduct of drug studies in China, as well as strengthen the management of such studies.
McDermott Will & Emery
The purchasing power of the Chinese middle class is reshaping the world's market for luxury brands, tourism, real estate, and private investments.
Jones Day
China has published various rules and policies promoting telemedicine services, and many businesses are interested in developing this market.
Ropes & Gray LLP
Additionally, it may be worthwhile to understand the level of compliance controls employed by the intermediary to assess third-party compliance risks.
Ropes & Gray LLP
China's recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable.
Jones Day
How the Opinions would be implemented is unclear and remains to be seen.
Ropes & Gray LLP
Unlike the DRR, the Revisions do not distinguish an international multicenter study from a drug registration study.
Ropes & Gray LLP
Ask a senior manager of a MedTech company in China what keeps her or him awake at night and "regulatory changes" will invariably be among the first things mentioned.
Foley & Lardner
These developments present significant opportunities for foreign health care providers and other investors.
Ropes & Gray LLP
The China Food and Drug Administration ("CFDA") recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority Review Designation Procedure for Medical Devices (CFDA Circular [2016] No.40, the "Circular").
Jones Day
Some pioneering industrial players have already made movements in this regard.
Ropes & Gray LLP
China's State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System ("MAH") for drugs in 10 provinces in China.
Ropes & Gray LLP
On March 23, 2016, the China Food and Drug Administration ("CFDA") and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules...
King & Wood Mallesons
We have analyzed drug policies with regard to drug pricing and the centralized procurement of drugs in the previous Key 2015 Healthcare and Pharmaceutical Policies: Pharmaceuticals.
Most Popular Recent Articles
Han Kun Law Offices
With the continuous development of cloud computing and internet of things technology, the internet is further reshaping the healthcare industry.
Jun He Law Office
In early 2016, the Price Supervision and Anti-monopoly Bureau of China's National Development and Reform Commission issued the article "Key Issues on Price Supervision and Anti-monopoly in 2016" . . .
Jun He Law Office
Last year ushered in an abundance of new laws and regulations for the pharmaceutical industry in China. Various pharmaceutical policies, including national laws and regulations as well as local supporting policies such as the dual-invoice system, . . .
Han Kun Law Offices
As mentioned in Study on Foreign-Invested Medical Institutions (I), although China had at one time implemented a pilot program for establishing wholly foreign-owned hospitals, current policies prohibit full ownership.
McDermott Will & Emery
The purchasing power of the Chinese middle class is reshaping the world's market for luxury brands, tourism, real estate, and private investments.
Han Kun Law Offices
Can foreign investors set up wholly-owned medical institutions in China? This is a question that clients constantly ask when entering the Chinese healthcare industry...
Ropes & Gray LLP
The Revisions would standardize the conduct of drug studies in China, as well as strengthen the management of such studies.
Jones Day
Some pioneering industrial players have already made movements in this regard.
Ropes & Gray LLP
Additionally, it may be worthwhile to understand the level of compliance controls employed by the intermediary to assess third-party compliance risks.
Jones Day
How the Opinions would be implemented is unclear and remains to be seen.
Ropes & Gray LLP
China's State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System ("MAH") for drugs in 10 provinces in China.
Ropes & Gray LLP
China's recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable.
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