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
发表于 2010-5-30 13:14:39