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Medicines Act

(CHAPTER 176, Sections 18 and 74)

Medicines (Clinical Trials) Regulations

Rg 3

REVISED EDITION 1990

(25th March 1992)

[27th March 1978]

Citation

1. These Regulations may be cited as the Medicines (Clinical Trials) Regulations.

Definitions

2. In these Regulations, unless the context otherwise requires —

“certificate” means a certificate issued under regulation 5;

“director” means a doctor or dentist specified in a certificate as the person who is responsible for the conduct and supervision of a clinical trial;

“holder of a certificate” means a doctor or dentist to whom a certificate has been issued under regulation 5;

“subject” means a person to whom the test material is to be administered in a clinical trial;

“test material” means any medicinal product administered to a subject in a clinical trial.

Clinical trial

3. No clinical trial shall be conducted except in accordance with these Regulations.

Exclusions

4. Sections 5 and 6 of the Act shall not apply to any clinical trial conducted under these Regulations.

Application for certificate for clinical trial

5.—(1) No person shall conduct or cause or permit to be conducted a clinical trial except in accordance with a certificate issued by the licensing authority.

(2) An application for a certificate shall be in such form as the licensing authority may require.

(3) A certificate may be issued subject to such terms and conditions as the licensing authority may think fit to impose.

(4) The licensing authority may, without assigning any reason, refuse to issue a certificate or may suspend or revoke any certificate already issued.

(5) Any person aggrieved by such refusal, suspension or revocation may appeal to the Minister whose decision shall be final.

Period of validity of clinical trial certificate

6. Any certificate issued shall be valid for a period of two years with effect from the date on which it was issued.

Director to supervise clinical trial

7. Every clinical trial shall be conducted under the charge and supervision of a director.

Clinical trial confined to place specified

8. No clinical trial shall be conducted except at such place as may be specified in the certificate.

Discontinuance of clinical trial

9. Where a clinical trial is discontinued, the holder of a certificate shall forthwith inform the licensing authority of the discontinuance and the reasons therefor.

Change of director

10. Where there is a change of director during a clinical trial, the holder of a certificate shall forthwith notify the licensing authority of the change and shall furnish to the licensing authority particulars of the new director.

Restrictions on use of a person as a subject in clinical trial

11. A holder of a certificate shall not use a person as a subject in a clinical trial unless the following conditions are satisfied:

(a)	in the case of a person of or over 21 years of age, except with the consent of that person;
(b)	in the case of a person under 21 years of age who is married, except with the consent of that person;
(c)	in the case of a person under 21 years of age who is not married, if that person together with his parent or guardian (if there is no parent living) give consent thereto;
(d)	in the case of a person who is of unsound mind, if the spouse, parent, guardian (if there is no parent) or any other person having the charge of him, as the case may be, gives consent thereto.

Coercion

12. No person shall by means of any threat or coercion compel or induce another person to be a subject in a clinical trial.

Full explanation of objects, risks, etc., of clinical trial

13. Before a clinical trial is carried out or conducted, the holder of a certificate shall give the subject or the person who gives consent on his behalf, a full and reasonable explanation of the nature and object of such trial and the risks involved, if any.

Subjects to be treated by certificate holders

14.—(1) No person, other than a holder of a certificate or any person assisting him in a clinical trial, shall treat a subject or administer any test material to him.

(2) In an emergency, any doctor or dentist may, in the absence of the holder of a certificate or any person assisting him in the clinical trial, treat a subject if it is in the interest of the subject.

Licensing authority may require information and report

15.—(1) The licensing authority may require the holder of a certificate during a clinical trial to furnish him with any information or report at such times and in such manner as the licensing authority may require.

(2) The holder of a certificate shall submit to the licensing authority a final report of the clinical trial within 3 months after the completion of the trial or such longer period as the licensing authority may allow.

Notification of adverse effects

16. The holder of a certificate shall, as soon as is practicable, notify the licensing authority in writing of any adverse effects or reactions which are likely to affect the safety or well-being of the subject which have arisen during the clinical trial or which have come to his knowledge from reports of similar clinical trials conducted elsewhere.

Test materials’ particulars, identification and storage

17.—(1) The holder of a certificate shall ensure that all test materials have the following particulars written on the containers:

(a)	the designation, reference number or other identification mark of each item of such material;
(b)	the name and address of the manufacturer;
(c)	the production batch number of the material;
(d)	the name or other identification mark of the subject for whom the test material is intended;
(e)	the date of manufacture and the expiry date of the test material;
(f)	the storage conditions appropriate for each item of test material as may be indicated by the manufacturer; and
(g)	the words: “This product shall only be used under strict medical surveillance” or “This product shall only be used under strict dental surveillance”, as the case may be.

(2) No test material shall be used in a clinical trial if the container in which the test material is stored is not marked and labelled with the particulars specified in paragraph (1).

(3) If any code or cipher is used in the labelling of a test material the key to the code or cipher shall be made known to the licensing authority and be readily accessible to any doctor or dentist in an emergency.

(4) All test materials shall be stored in such manner as to be easily identifiable. If the test material cannot be identified, the material shall not be used and shall be surrendered to the licensing authority.

Record of clinical trials

18.—(1) The holder of a certificate shall keep adequate clinical records of each subject for the duration of the clinical trial.

(2) The holder of a certificate shall ensure that such records are —

(a)	kept up to date at all times;
(b)	available at all times for inspection by the licensing authority or any person authorised by him in that behalf; and
(c)	kept for a period of 6 years from the date of completion of the clinical trial.

(3) The holder of a certificate shall maintain a record containing the names and such other particulars of every person assisting or participating in a clinical trial.

Financial interest in clinical trial

19. The holder of a certificate or any person assisting him in a clinical trial or any subject in a clinical trial shall not directly or indirectly have any financial interest in the trial.

Penalty

20. Any person who contravenes or fails to comply with regulation 5(1) or regulations 7 to 19 shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding one year or to both.