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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 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
Major vaccine standards change in China
- Sidley Austin LLP
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- China
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- January 24 2011
The State Food and Drug Administration ("SFDA") recently issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines ("Vaccine Notice"
Extended scope EU Penalties Regulation enters into force
- Sidley Austin LLP
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- European Union
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- July 13 2012
As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover
FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications
- Sidley Austin LLP
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- USA
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- November 19 2010
The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first substantive guidance from FDA on this issue
Appeals Court issues important ruling in fraud and abuse case involving individual liability
- Sidley Austin LLP
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- USA
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- July 31 2012
A recent D.C. Circuit decision in Friedman v. Sebelius overturned the exclusions of three Purdue pharma executives from participation in federal healthcare programs, holding that the Department of Health and Human Services acted arbitrarily in imposing extraordinarily lengthy exclusions
FDA proposes two groundbreaking food safety rules
- Sidley Austin LLP
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- USA
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- January 8 2013
On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety
China proposes new ADR reporting rule
- Sidley Austin LLP
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- China
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- July 30 2009
On June 30, the Ministry of Health ("MOH") and the State Food and Drug Administration ("SFDA") of China issued a draft revision of the Rule on Adverse Drug Reaction Reporting and Monitoring (the "Reporting Rule"
Recent SFDA and MOH new developments
- Sidley Austin LLP
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- USA
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- January 21 2011
The State Food and Drug Administration ("SFDA, the Agency") issued an order in late December 2010 to require compulsory incorporation of a monitoring bar code issued by the agency in the direct packaging materials of compound pharmaceutical formulations containing ephedrine, codeine and diphenoxylate, in order to prevent abuse and misuse of such products
European Commission allows submission of new data in support of probiotic health claims
- Sidley Austin LLP
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- European Union
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- June 20 2011
The European Commission has opened a four-month window, starting on June 1 and closing on September 30, 2011, during which stakeholders can submit new data to Member States in support of certain probiotic health claims rejected by the European Food Safety Authority
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- Author - Scott Bass
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