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[【转贴】] European Medicines Agency Annual Reports 2009 byEMA (新闻)

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发表于 2010-5-30 13:14:39 | 显示全部楼层 |阅读模式
General Reporting - Executive - Directorate

European Medicines Agency Annual Reports

NOTE: The English versions of these documents are the official texts. While care has been taken to provide faithful translations, the Agency accepts no responsibility for any errors that may have been inadvertently introduced by the translators.

整个报告分为两个部分:

主报告部分:主要关注第二部分
  

2. Medicines for human use  19
  2.1. Orphan medicinal product designation  19
  2.2. Scientific advice and protocol assistance  22
  2.3. Initial evaluation  26
  2.4. Post-authorisation activities  31
  2.5. Pharmacovigilance and maintenance activities  36
  2.6. Parallel distribution and certificates  40
  2.7. Arbitration and Community referrals  41
  2.8. Medicines for children  46
  2.9. Herbal medicinal products  48
  2.10. Advanced therapies and other emerging therapies and new technologies  49
  2.11. Provision of information to patients and healthcare professionals  52
  2.12. Scientific committees, working parties and scientific advisory groups  53
  2.13. Coordination Group for Mutual-Recognition and Decentralised Procedures – Human  55

附录部分:主要是名录汇编,可用于查询

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