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ich gcp

ICH GCP: ICH is the International Conference on Harmonisation of technical Requirements for Registration of Pharmaceuticals for Human Use.

-The current version of ICH was established in 1996 as a joint regulatory Industry/Project to improve the efficacy of process for developing and registering new medicinal products in Europe, Japan, and the US and observers: Canada, Australia, WHO, and EFTA(European Free Trade Association).

-Since the vast majority of new drugs and medicines are developed in western Europe,Japan, and US, when ICH was established it was agreed that its Scope would be Confirmed to registration in those three areas.

-Each country has its own Regulatory Authorities(RAs). For example, in the United States, the Food and Drug Administration(FDA) oversees the regulatory process for investigational product(IP) Development.

-Because research is conducted globally, ICH has become the international standard for conducting clinical research.

-Good Clinical Practice(GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

The Principles of ICH-GCP:

ICH-GCP section 2 reviews the 13 principles of ICH-GCP which require that:

1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki.

2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for that individual trial subject and society.

3. There should be clinical and scientific judgement involved regarding the risk to the subject as compared to the benefit of the research. Determinations must be as to the risk-to-benefit ratio.

4. The rights, safety and well-being of the trial subjects are the most important consideration and should prevail over interests of science and society.

5. The available non-clinical and clinical information on the investigational products should be adequate to supports the proposed trial.

6. The medical care given to, and medical decisions made on behalf of the subjects should always be the responsibilities of a qualified physician,or when appropriate, of a qualified dentist.

7. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

8. A trial should be conducted in compliance with a protocol that has received prior Institutional Review Board(IRB)/Indepedent comittee(IEC).

9.Each individual involved in conducting a trial should be qualified by education, training and Experience.

11. Freely given informed consent should be obtained from every subject prior to clinical trial participation.

11. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

12. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements.

13. Investigational Products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice. They should be used in accordance with the approved protocol.