China SFDA Publishes New Technical Review Guidelines for Drugs

Global Life Sciences: China Update

On March 23, 2011, the Center for Drug Evaluation (CDE) of the P.R.C. 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).

The Guidelines mainly address procedural rules and allocation of responsibilities within different departments of CDE, but certain provisions in the Guidelines are worth highlighting:

  • While CDE will continue following the statutory timelines imposed by SFDA’s drug registration rules, it will make additional efforts to develop and publish target approval timelines for each individual application.
  • CDE is planning to establish an Information Management System for Clinical Studies of New Drugs, which will post information on clinical studies and will be made accessible to the general public.
  • In case of adverse events or serious adverse events in clinical studies, sponsors will be expected to analyze and evaluate such events, identify and propose solutions and report the same to CDE. CDE may make suggestions accordingly and take remedial actions to address those events.
  • With regard to generic applications, CDE will formulate a list of brand-name drugs with generic equivalents and establish systems better to manage their bio-equivalency. It will also develop technical review strategies particularly for those generic drugs that, if approved, would increase their availability to the public and address the significant public health needs of China.
  • CDE pledges more communication with the applicants on technical issues identified in its review. The communication may be done by video, email, fax, phone and face-to-face meetings.

The China Life Sciences Practice of Sidley Austin LLP

Sidley has a powerful, fully integrated life sciences practice serving multi-national pharmaceutical, biotechnology, medical device and food companies in every aspect of their business operations in China. Sidley’s Foreign Direct Investment, general Commercial, Corporate, M&A/Joint Venture, Antitrust, FCPA, Licensing, IP, provincial government work, as well our Regulatory practice permits us to serve virtually every legal need of our life sciences clients in China.

Sidley is the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China. As an integral part of our Global Life Sciences practice, we bring our knowledge of industry practices in the U.S. and EU to each project in China and help develop global Standard Operation Procedures (SOPs) and benchmark best practices.

For further information on the China Life Sciences Practice, please contact Chen Yang (+86.10.6505.5359,, Zhengyu Tang (+86.21.2322.9318, or Katherine Wang (+86.21.2322.9303, +1.213.896.6141,

Sidley Global Life Sciences Practice

On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability, Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology.

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For further information on the Global Life Sciences Practice, please contact Scott Bass (+1.202.736.8684, +1.212.839.5613, or James C. Stansel (+1.202.736.8092,

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