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NEW DRUG APPROVAL PROCEDURE IN INDIA


Mutual Recognition Procedure
The mutual recognition procedure (MRP) is similar to the de-centralized procedure with some differences. The mutual recognition procedure is applicable to medicinal products which have received a marketing authorization in any member state whereas the decentralized procedure is applicable to those products which were never approved in any member states of the European Union. The MRP is used to obtain marketing authorizations in various several member states. The evaluation of application by RMS can be taken within 90 days instead of 120 days (in decentralized procedure). After the grant of marketing authorization, the product can be marketed, which may be called as Phase IV trials, wherein new uses or new populations, long-term effects etc. can be explored.

Drug Approval Process In China
In 1963, for the management of new drugs, Chinese Ministry of Health planned drug regulation. The China’s State Pharmaceutical Administration in collaboration with Ministry of Health, in 1979, published the New Drug Management Regulations (no need to conduct systematic scientific experiments on new drugs). In view of protecting the public health and promoting the economic developments in pharmaceuticals, the first comprehensive Drug Administrative Law was framed in 1985. This law was amended in 1999 by two additional provisions for new drug approval and provisions for new biological product approval. The approval process of New Drug Applications (NDA) includes sufficient preclinical data for verification of drug’s safety and justification of the commencement of clinical trials. The Drug Administrative Law was further revised in 2001 requiring premarket testing, approval for new drug products, and prohibits drug adulteration.

The Drug Administrative Law authorizes the State Food and Drug Administration (SFDA) to approve new drugs for marketing. The new drug registration process also consists of the clinical study application and the new drug application. The Provincial Drug Administration Authorities (PDAAs) should organize the works of the formal review of submitted materials i.e. on-site examination and sampling just after receiving the drug registration application. The aim behind the formal review is to guarantee the content and format of the submitted materials is in line with the requirements and all the required materials have been submitted. After formal review, the PDAAs send the qualified applications to the SFDA for further review. The import drug registration application should be directly submitted to SFDA by the applicant. SFDA’s Department of Drug Registration carefully reviews the completeness of the submitted materials, files the qualified applications and transmits all the materials of qualified applications to the Center for Drug Evaluation (CDE) directly attracted to SFDA. CDE determine whether the safety and effectiveness information submitted for a new drug are adequate for manufacturing and marketing approval and send the report of review to SFDA. SFDA Carefully consider the recommendations and review results of CDE and makes a decision whether or not the drug registration application can be approved and issues the certificate of drug approval and drug approval number to the qualified applicant. Figure 5 -6 represents the clinical trial approval process and new drug approval process of China, respectively.

Drug Approval Process In Australia
In the history of drug regulatory system in Australian, thalidomide disaster was a key factor. In 1948, the first advisory committee to review drugs was set up and further in 1964, the first Commonwealth advisory committee in Australia was established. The first federal act relating to therapeutic goods was enacted in 1965. In response of lacking control over locally manufactured products, the Therapeutic Goods Act was changed in 1989 and the Therapeutic Goods Administration (TGA) was created.

Any person seeking approval of a new drug in Australia should first file a clinical trial application for conducting human studies. The clinical trials in Australia can be conducted under two schemes, i.e. either under the Clinical Trial Exemption (CTX) Scheme or under the Clinical Trial Notification (CTN) Scheme. In the latter scheme, application is directly submitted to the Human Research Ethics Committee (HREC) which assesses the validity of design of clinical trial, its ethical acceptability, approval, safety and efficacy of the drug as well. The final consent for conducting trial is given by the approving authority after due advice from the HREC. The commencement of clinical trial takes place only after the due notification to the TGA and the appropriate notification fee to be paid. In CTX scheme, an application to conduct clinical trials is submitted to the TGA for evaluation and comment. The clinical trials can be conducted (under the CTX application) without further assessment by the TGA and the conduct of each trial should be notified to the TGA. Figure 7 represents the CTA by CTX scheme. An application is submitted to TGA to register the drug in Australian Register of Therapeutic Goods (ARTG) after the completion of clinical trials. The application consists of data to support the quality, safety and efficacy of the product for its intended use. The application is assessed (on an administrative level) to make sure for compliance with basic guidelines and further evaluated by different sections and advice can also be sought on key issues to take final decision. A company can make comments on the evaluation report, if necessary. A delegate (decision-maker) within the TGA after due advice of the ADEC, take a decision to approve or reject the product. The Australian Drug Evaluation Committee (ADEC) usually gives advice for new medicines. Figure 8 represent the new drug approval process in Australia. When the drug is approved and distributed in the market the drug, it is considered to be in Phase IV trials. In this phase, new uses or new populations, long-term effects, etc. can be explored.

Table 1. Comparison of Drug approval process.

Country

Time for Regulatory Approval of CTA/IND Application

Time for Evaluation of MAA

MAA Fee

Australia

120 day

50 days

$192,400

China

50 days

180 days

DNA

India

16-18 weeks

8-12 weeks

50,000 INR

UK*

35 days

210 days

£254100

USA

30 days

180 days

$217,787

*By Centralized Procedure; MAA-Marketing Authorization Application, IND-Investigational New Drug, CTA-Clinical Trial Authorization, DNA-Data Not Available.

LOGARITHAMIC PRESENTATION OF NDA PROCESS IN DIFFERENT COUNTRIES:

IND-Investigational New Drug, FDA-Food and Drug Administration, NDA-New Drug Application, CDER-Centre for Drug Evaluation and Research

Figure 1: New Drug Application Approval Process of FDA


Figure 2: Clinical Trial Authorization Process of EU


MAA-Marketing Authorization Application, EMEA-European Medicine Evaluation Agency, EU-European Unionion in EU

Figure 3:Centralized Procedure for Marketing Authorization


CMS(s)-Concerned Member State(s), RMS-Reference Member State, CHMP-Committee for Human Medicinal Products

Figure 4: Decentralised Procedure for Marketing Authorization in EU


CDE-Centre for Drug Evaluation, SFDA-State Food and Drug Administration

Figure 5: Clinical Trial Application Approval Process of China

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