Medicines (Clinical Trials) Regulations
Table of Contents
1 Citation
2 Definitions
3 Clinical trial
4 Exclusions
5 Application for certificate for clinical trial
6 Period of validity of clinical trial certificate
7 Director to supervise clinical trial
8 Clinical trial confined to place specified
9 Discontinuance of clinical trial
10 Change of director
11 Restrictions on use of a person as a subject in clinical trial
12 Coercion
13 Full explanation of objects, risks, etc., of clinical trial
14 Subjects to be treated by certificate holders
15 Licensing authority may require information and report
16 Notification of adverse effects
17 Test materials’ particulars, identification and storage
18 Record of clinical trials
19 Financial interest in clinical trial
20 Penalty
Legislative History