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2012年12月7日中国化学制药工业协会收到美国FDA驻华办公室通知。
根据GDUFA法规要求，仿制药企业需要向FDA进行自认定。FDA发布最新通知将仿制药企业自认定时限延长两周，截止日期改为2012年12月18日。请所有中国相关输美企业加紧完成自认定工作。
详细信息详见以下英文版通知（正在进行翻译，稍后会放出中文对照版）。
自认定信息提交途径和形式见FDA网站：
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm320942.htm
FDA Announces a Two-Week Grace Period for Generic Drug Facility Identification -- Deadline December 18, 2012
The FY 2013 reporting period for facility self-identification closed on December 3, 2012. Under the statute, generic drug products manufactured in facilities that have not self-identified, or including active ingredients manufactured in facilities that have not self-identified, are misbranded. FDA is announcing, however, that there will be a two-week grace period, until December 18, 2012, in which facilities that have not yet successfully completed the self-identification process may do so without penalty.
The Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III) requires the identification of facilities involved in the manufacture of human generic drugs and associated active pharmaceutical ingredients. Self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay annual facility user fees. Second, self-identification is a central component of an effort to promote global supply chain transparency and facilitate inspections and compliance.
To date, more than 1,700 facilities have self-identified for FY 2013. This figure is below estimates of the universe of generic drug facilities. Similarly, an analysis of facilities identified in Abbreviated New Drug Applications and Prior Approval Supplements submitted since October 1, 2012 suggests that not all facilities are self-identifying. One out of eight facilities in these recent submissions has failed to self-identify, a trend that, if uncorrected, will result in higher individual facility fee amounts.
The two week grace period should enable facilities who have not yet registered to do so. FDA does not want to penalize companies that have already complied with this new requirement by setting higher annual facility fee rates based on an artificially low industry reporting base.
Answers to specific questions about who must self-identify, what type of information is to be submitted and the means and format for submission of this information is available at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm320942.htm