Regulatory Approval Process- REX

Regulatory approval procedure of a drug :

Regulatory approval procedure of a drug BY S.REX JEYA RAJKUMAR M.Tech (Biotechnology)

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REGULATORY PROCESS: A regulatory process by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. 2 KLINTELLIGEN HEALTHCARE

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INTRODUCTION: The new drug approval is of two phase process - the first phase for clinical trials and second phase for marketing authorization of drug . Firstly, non-clinical studies of a drug are completed to ensure efficacy and safety, and then application for conduct of clinical trials is submitted to the competent authority of the concerned country. Thereafter, the clinical trials can be conducted (phase I to phase IV). These studies are performed to ensure the efficacy, safety and optimizing the dose of drug in human beings. After the completion of clinical studies of the drug, then an application to the competent authority of the concerned country for the approval of drug for marketing is submitted. 3 KLINTELLIGEN HEALTHCARE

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The competent authority review the application and approve the drug for marketing only if the drug is found to be safe and effective in human being or the drug have more desirable effect as compare to the adverse effect . Even after the approval of new drug, government should monitor its safety due to appearance of some side effects, when it is used in larger population. The interactions with other drugs, which were not assessed in a pre-marketing research trial and its adverse effects (in particular populations) should also be monitored. 4 KLINTELLIGEN HEALTHCARE

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DRUG APROVAL PROCESS IN INDIA An application to conduct clinical trials in India should be submitted along with the data of chemistry, manufacturing, control and animal studies to DCGI . The date regarding the trial protocol, investigator's brochures, and informed consent documents should also be attached. A copy of the application must be submitted to the ethical committee and the clinical trials are conducted only after approval of DCGI and ethical committee. The therapeutic uses and effective dose ranges are determined in Phase II trials in 10-12 patients at each dose level. Phase III trials should be conducted on a minimum of 500 patients spread across 10-15 centers, If the new drug substance is not marketed in any other country. The new drug registration is applied after the completion of clinical trials. The information regarding the prescription, samples and testing protocols, product monograph, labels must also be submitted. The application can be reviewed in a range of about 12-18 months. 5 KLINTELLIGEN HEALTHCARE

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After the NDA approval, when a company is allowed to distribute and market the product, it is considered to be in Phase IV trials, in which new uses or new populations, long-term effects, etc. are explored. The drug approval process varies from one country to another. Other issues where the difference appears are, time taken for the approval of a CTA application, time taken in evaluation of marketing authorization application, registration fee, registration process and marketing exclusivity. Some counties have two review processes as normal review process and accelerated review process as in USA, China etc. and some countries have only a single review process as in India. 6 KLINTELLIGEN HEALTHCARE

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Table: Comparison of Drug approval process. *By Centralized Procedure; DNA-Data Not Available. 7 KLINTELLIGEN HEALTHCARE

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New Drug Application Approval Process of FDA: 8 KLINTELLIGEN HEALTHCARE

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Clinical Trial Application Approval Process of China: 10 KLINTELLIGEN HEALTHCARE

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Clinical Trial Application Approval Process of Australia: 11 KLINTELLIGEN HEALTHCARE

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CONCLUSION: Generally, the drug approval process comprised mainly the two steps, application to conduct clinical trial and application to the regulatory authority for marketing authorization of drug. The new drug approval process of various countries is similar in some of the aspects whereas it differs in some aspects. In most of the counties, sponsor firstly files an application to conduct clinical trial, and only after the approval by the regulatory authority, the applicant conducts the clinical studies and further submits an application to the regulatory authority for marketing authorization of drug. In all countries, information submitted to regulatory authorities regarding the quality, safety and efficacy of drug is similar; however, the time, fee and review process of clinical trials and marketing authorization application differs. The International Conference on Harmonization ( ICH ) has taken major steps for recommendations in the uniform interpretation and application of technical guidelines and requirements. This step will ultimately reduce the need to duplicate work carried out during the research and development of new drugs. Therefore, harmonization of drug approval processes either by ICH or WHO may be initiated at global level. 12 KLINTELLIGEN HEALTHCARE

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ACRONYMS: MAA-Marketing Authorization Application IND-Investigational New Drug CTA-Clinical Trial Authorization IND-Investigational New Drug, FDA-Food and Drug Administration NDA-New Drug Application CDER-Centre for Drug Evaluation and Research CA- Competent Authority PDAA- Provincial Drug Administration Authority DSEB-Drug Safety and Evaluation Branch TGA-Therapeutic Goods Administration ADEC-Australian Drug Evaluation Committee SFDA-State Food and Drug Administration 13 KLINTELLIGEN HEALTHCARE

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THANK YOU… 14 KLINTELLIGEN HEALTHCARE