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Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more
China’s Ministry of Health released the new essential drug list (the “2012 EDL”) on March 15, 2013, effective as of May 1, 2013. Essential drugs are those which meet basic health care demands in suitable dosage forms with...more
The Chinese State Food and Drug Administration (“SFDA”) created a fast track review and approval process for novel drugs in its Drug Registration Rules issued in 2007. The fast track approval process is available for (1)...more
In This Issue: New Drug GSP Issued: Supervision on Drug Distribution to be Enhanced (China Securities Journal 2013-02-20) – February 20, 2013; China to Encourage Innovative Drug Development (Xinhua News Agency...more
To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more
In This Issue: Li Keqiang Comments from the 12th Plenary Meeting of the Medical Reform Leading Group (USCBC 2012-01-06) – January 6, 2013; MOH Announces Roadmap for Medical Reform (USCBC 2012-01-10) – January 10, 2013;...more
The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013. After three rounds of...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences - News & Regulations: ..Industry Calls for Reform of Lagging Drug Review System (Global Times 2012-12-02) – December 3, 2012...more
The China Trade Marks Office (CTMO) recently announced that from 1 January 2013 it is accepting applications to register trade marks in relation to retail or wholesale services for pharmaceutical, veterinary and sanitary...more
New legal ground is expected to be broken this year in areas of importance to companies and their directors, officers and executives. We see those developments coming from around the globe and defining the litigation...more
On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more
In This Issue: Investor Q&A; Key Regulatory Issues for Strategic Life Sciences Partnerships in China; Compulsory Patent Licensing in China; and New Developments on the “Patentable Subject Matter” Requirement of U.S....more
In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more
I recently spent some time in the “Golden Triangle,” which on its Northern edge is delineated by the area between Nanjing and Shanghai. What is initially striking is the absolutely mammoth investment in infrastructure that...more
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