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China develops new rules to simplify medical device re-registration process

Sidley Austin LLP
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China
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April 1 2013

China's newly restructured food and drug regulatory agency, the China Food and Drug Administration ("CFDA"), has published new draft rules to

SFDA 2012 Anual Drug Review Report highlights innovator focus

Sidley Austin LLP
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China
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March 8 2013

On February 28, 2013, the Center for Drug Evaluation of the State Foodand Drug Administration ("CDE"), the key agency reviewing safety andefficacy

China amends major regulation on drug distribution

Sidley Austin LLP
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China
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February 25 2013

On January 22, 2013, the Ministry of Health of China published the amended Good Supply Practice for Drugs ("Drug GSP"). Drug GSP is one of the key

China encourages pharmaceutical companies to timely pursue new GMP certification

Sidley Austin LLP
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China
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January 15 2013

In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which

China promulgates a PSUR guidance for approved drugs

Sidley Austin LLP
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China
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September 25 2012

On September 13, 2012, the State Food and Drug Administration (“SFDA”) published a Technical Guidance for the Periodic Safety Update Report for Marketed Drugs (the “PSUR Guidance”

Chinese Ministry of Health issues guidance to strengthen anti-bribery control at public hospitals

Sidley Austin LLP
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China
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September 6 2012

On August 1, 2012, the Ministry of Health of China (“MOH”) issued the draft Guidance on Strengthening Anti-Bribery Control at Public Hospitals

New Chinese medical device GCP unveiled for public comments

Sidley Austin LLP
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China
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September 4 2012

The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012

SFDA to enforce blacklist system for unsafe drug and device products

Sidley Austin LLP
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China
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August 21 2012

Beginning October 1, 2012, China’s State Food and Drug Administration (SFDA), including its provincial counterparts, will implement a nationwide information disclosure system called the Drug Safety Blacklist (“Blacklist”), which includes medical device products as well

MOH publishes new draft of Drug GSP regulation

Sidley Austin LLP
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China
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May 11 2012

On April 25, the Ministry of Health of China published a new draft of the Drug GSP for public comment, and key changes are:

China SFDA publishes new technical review guidelines for drugs

Sidley Austin LLP
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China
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March 29 2011

On March 23, 2011, the Center for Drug Evaluation (CDE) of the PRC State Food and Drug Administration (SFDA), the equivalent of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, published new guidelines for its technical review of drug registration applications in China (the Guidelines), including applications for clinical studies (IND), applications for production and market approvals of new drugs (NDA), as well as applications for generic drugs (ANDA