This Regulations are enacted pursuant to Paragraph 2, Article 42 of the Pharmaceutical Affairs Act.

The Competent Authority as referred to herein means the Ministry of Health and Welfare.

Terms used in this Regulations are defined as follows:
1.Clinical Trial: Any investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmaceutical effects of an investigational product(s).
2.Nonclinical Study: Biomedical studies not performed on human subjects.
3.Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
4.Informed Consent Form: A written documentation signed and dated by a subject who voluntarily confirms his or her willingness to participate in a particular trial, after having been informed and understand all aspects of the trial that are relevant to the subject's decision to participate.
5.Ethics Committee/ Institutional Review Board (IRB): An independent committee constituted of medical professionals and impartial persons with no medical professions, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial.
6.Institution/Trial Site: A medical institution where clinical trials are conducted.
7.Investigator: A person responsible for the conduct of the clinical trial at a trial site.
8.Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation and management of a clinical trial.
9.Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
10.Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
11.Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.
12.Investigator's Brochure (IB): A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
13.Adverse Drug Reaction (ADR): All noxious and unexpected response to a medicinal product. An adverse drug reaction should be reasonably related to the use of the investigational product(s).
14.Adverse Event (AE): Any untoward medical occurrence in a clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with the use of the investigational product(s).
15.Blinding/Masking: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

Clinical trials should be conducted in accordance with the ethical principles of the Declaration of Helsinki.
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks and inconveniences.
The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
The Ethics Committee should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.

The investigator should obtain the informed consent form freely given by the subjects prior to the beginning of the trial.
The investigator, or a person designated by the investigator, should fully inform the subject of all pertinent aspects of the trial, including the contents of the informed consent form and the documentations approved by the Ethics Committee. The investigator, or designated person, should ensure the content of inform consent form and other trial-related documentations are well understood, signed and dated by the subject.
For the consent mentioned in the preceding two paragraphs, where the subject is incompetent, the consent should be performed by his or her legal representative; where the subject is of limited legal capacity, consent should be obtained from his or her legal representative; where the subject who is neither incompetent nor of limited legal capacity, yet is unable to give consent due to insanity or the absence of discernment, the consent could be given by the subject's legally acceptable representative.
The subject's legally acceptable representative refers to the subject’s spouse and cohabiting families.

During and following a subject's participation in a trial, the investigator and the institution should ensure that adequate medical care is provided to a subject for any adverse events related to the trial. The investigator should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.

The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.

Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial.
During the trial, neither the investigator, nor the trial staff, should coerce or unduly influence a subject to continue the trial.

A subject is entitled to withdraw from a clinical trial at any time without giving reason(s).
Under the circumstances referred to in the preceding paragraph, the investigator should make a reasonable effort to ascertain the reason(s) while fully respecting the subject's rights and will.

In the aspect of amount and method of payment to subjects, the sponsor should not impose coercion or undue influences on the trial subjects.
The payment to a subject should be prorated and subject to the progress of the trial, instead of payment in full only after completion of the trial.
Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be clearly stated in the written informed consent form and any other written information to be provided to subjects. The way that the payment will be prorated should be specified.

Identities and records of the subjects that are related to the trial should be kept confidential.

Clinical trials should be scientifically based, and the protocol should be clearly defined and detailed.

No trials shall be conducted without approval from an Ethics Committee.
After reviewing the informed consent form, protocol and all other relevant documents, the Ethics Committee can approve the institution to conduct the clinical trial.

All trial staff should have qualified education, training and working experiences to assume their responsibilities in the trial.

All clinical trial documents should be recorded and retained.