Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
The China Food and Drug Administration (“CFDA”) recently announced several draft rules, most notably, the Draft Amendment of the Provisions for Drug Registration (also known as the Drug Registration Rules, DRR) and the Draft...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
The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...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
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
The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more
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