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Regulatory Requirement for Clinical Trial

Regulatory Requirement for Clinical Trial


10/02/2010

Domain: Pharma KPO Author: Arun Sharma arun8.s@tcs.com

TCS Internal

Regulatory Requirement for Clinical Trial

Purpose
The purpose of this document is to facilitate the user to understand the Regulatory Requirement for Clinical Trials

Introduction
Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the Food and Drug Administration (FDA) to establish these regulatory requirements. The European Medicines Agency (EMEA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are also important regulatory authorities in drug development. These three agencies oversee the three largest markets for drug sales

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Regulatory Requirement for Clinical Trial

Following are the regulatory requirement from FDA for Clinical Trials.

Electronic Records &Electronic Signature (21 CFR Part11) Protection Of Human Subjects(Informed Consent (21CFR PART 50) Financial Disclosure by Clinical Investigators (21 CFR PART 54) Institutional Review Boards (21 CFR PART 56) Investigational New Drug Application (21CFR PART 312 Bioavailability and Bioequivalence Requirements (21 CFR PART 320)

* Electronic record means any combination of text, graphics, data, audio, pictorial or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

*Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

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Regulatory Requirement for Clinical Trial

Protection of Human Subjects(Informed Consent(21CFR PART 50)


Under this no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative following information shall be provided to each subject:

Basic elements of informed consent: In seeking informed consent, the


A statement that the study involves research An explanation of the purposes of the research The expected duration of the subject's participation A description of the procedures to be followed Identification of any procedures which are experimental. A description of any reasonably foreseeable risks or discomforts to the subject. A description of any benefits to the subject or to others which may reasonably be expected from A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

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Regulatory Requirement for Clinical Trial

Financial Disclosure by Clinical Investigators (21 CFR PART 54)


The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant

Institutional Review Boards (21 CFR PART 56)


This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with this part is intended to protect the rights and welfare of human subjects involved in such investigations. Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

Investigational New Drug Application (21CFR PART 312)


This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications. Investigational new drug means a new drug or biological drug that is used in a clinical investigation (This application is based on pre-clinical data, typically from animal studies, that shows the drug is safe enough to be tested in humans.) The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? Is the drugs proposed labeling (package insert) appropriate, and what should it contain?

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Regulatory Requirement for Clinical Trial

Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drugs quality adequate to preserve the drugs identity, strength, quality, and purity?

Bioavailability and Bioequivalence Requirements (21 CFR PART 320)


Bioavailability means the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. Drug product means a finished dosage form, e.g., tablet, capsule, or solution that contains the active drug ingredient, generally, but not necessarily, in association with inactive ingredients Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain extended release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.

*IN INDIA CDSCO IS THE DRUG REGULATORY AUTHORITY

Function of CDSCO (Central Drug Standard Control Organization)


Approval of New Drug and Clinical Trials Import Registration and Licensing Testing of Drugs Banning of Drugs and Cosmetics

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Regulatory Requirement for Clinical Trial

Approval of Clinical Trials, Import, & Manufacture of New Drugs


Requirements and Guidelines - Schedule Y Rule 122 A Permission to import new drug Rule 122 B Permission to manufacture new drug Rule 122 DA Definition of Clinical trials Rule 122 E Definition of New Drugs* New substance having therapeutic indication Modified or new claims, new route administration for already approved drug Fixed Dose Combination

IMPORT, REGISTRATION AND LICENSING


Manufacturing sites and Products are required to be Registered Rules 21 to 30 Rules related to grant of Registration Certificate and Import License Schedule DI & DII Information required for registration of Mfg site and Product Registration Certificate(RC) and Import License - Valid for 3 years

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Regulatory Requirement for Clinical Trial

GUIDANCE FOR INDUSTRY


Submission of Clinical Trial Application for Evaluating Safety and Efficacy Requirements for permission of Drugs Approval Post approval changes in biological products: Quality safety and Efficacy Documents Preparation of the Quality Information for Drug Submission for Drug

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