New Drug Approval Process: Regulatory

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Abstract

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. This article will focus
the similarities and differences in drug approval process of various regulatory
bodies.

Key Words: Drug approval process, clinical trials, marketing.

Introduction

In the present scenario, countries have different regulatory requirements for

approval of a new drug. The single regulatory approach for marketing
authorization application (MAA) of a new drug product applicable to various
countries (on the basis of single dossier) is utmost difficult. Therefore, the
knowledge of exact and detailed regulatory requirements for MAA of each country
should be known to establish a suitable regulatory strategy [1].

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. 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 [2].

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 [3].
Drug Approval Process In USA

In 1820, the new era of USA drug regulation was started with the establishment
of U.S. Pharmacopoeia. In 1906, Congress passed the original Food and Drugs
Act, which require that drugs must meet official standards of strength and purity [4].
However, in 1937, due to sulphanilamide tragedy, the Federal Food, Drug and
Cosmetic Act (of 1938) was enacted and added new provisions that new drugs
must be shown safe before marketing. Further, in 1962, the Kefauver-Harris
Amendment Act was passed which require that manufacturers must prove that drug
is safe and effective (for the claims made in labelling) [5,6].

The Food and Drug Administration (FDA) is responsible for protecting and
promoting public health. Like general drug approval process, FDA’s new drug
approval process is also accomplished in two phases: clinical trials (CT) and new
drug application (NDA) approval[7]. FDA approval process begins only after
submission of investigational new drug (IND) application. The IND application
should provide high quality preclinical data to justify the testing of the drug in
humans. Almost 85% of drugs are subjected to clinical trials, for which IND
applications are filed. The next step is phase I clinical trials (1-3 years) on human
subjects (~100). The drug’s safety profile and pharmacokinetics of drug are
focused in this phase. Phase II trials (2 years) are performed if the drug
successfully passes phase I. To evaluate dosage, broad efficacy and additional
safety in people (~300) are the main objective of the phase II. If evidence of
effectiveness is shown in phase II, phase III studies (3-4 years) begins. These phase
III concerns more about safety and effectiveness of drug from data of different
populations, dosages and its combination with other drugs in several hundred to
about 3,000 peoples[8, 9, 10]. A new drug application (NDA) can be filed only when
the drug successfully passes all three phases of clinical trials and includes all
animal and human data, data analyses, pharmacokinetics of drug and its
manufacturing and proposed labelling. The preclinical, clinical reports and risk-
benefit analysis (product’s beneficial effects outweigh its possible harmful effects)
are reviewed at the Center for Drug Evaluation and Research by a team of
scientists. Generally approval of an NDA is granted within two years (on an
average), however, this process can be completed from two months to several
years. The innovating company is allowed to market the drug after the approval of
an NDA and is considered to be in Phase IV trials. In this phase, new areas, uses or
new populations, long-term effects, and how participants respond to different
dosages are explored[10, 11]. Figure 1 represents the new drug approval process of
FDA.

Drug Approval Process In Europe

In European Union (EU), the medical products were approved for marketing at the
National level initially. The mutual recognization procedure was introduced in
1983 and a single national review in case of pharmaceutical/medicinal product for
marketing authorizations in all EU’s countries was made feasible. The primary aim
of this procedure was to create a united standard for product review among
national regulatory authorities. In 1987, for high-technology or biologically
derived products, the concertration procedure was established by directive 87/22,
in which product assessment should be completed by Committee for Proprietary
Medicinal Products (CPMP) besides the the normal national regulatory review.
Further, in 1993, by council regulation (EEC) 2309/93, the concertration procedure
was replaced with centralised procedure, by which all the high-tech and
biologically derived product was reviewed and granted EU’s wide marketing
authorization by the EU’s CPMP[12].

Similarly, the drug approval process in European countries is also accomplished in

two phases: clinical trial and marketing authorization. A clinical trial application
(CTA) is filed to the competent authority of the state to conduct the clinical trial
within EU. The competent authority of that member state evaluates the application.
The clinical trials are conducted only after the approval. The purpose and phases of
clinical trials are similar as specified in FDA drug approval process [13]. Figure 2
represent the clinical trial authorization process in EU.

After completing of all three phases of clinical trial, marketing authorization

application is filed including all animal and human data, its analyses, as well as
pharmacokinetics, manufacturing and proposed labelling. In the EU’s countries,
the company have a choice of following regulatory procedures:

Centralized Procedure

The Committee for Human Medicinal Products (CHMP) evaluate the applications
received by the EMEA. In view of the applicant's preference, CHMP contracts out
assessment work in one of the member states (the "rapporteur"). After the complete
assessment, the CHMP deliver opinion to EU Commission within 210 days. The
EU Commission requests comments from other member states, if a positive
opinion from CHMP is received. The other member states can respond in about 28
days. When a licence is recommended, a European Public Assessment Report
(EPAR) is produced and marketing authorisation is issued. This authorisation is
valid throughout the European Union and is for five years, however, the extension
can be applied to the EMEA three months before the expiration of this period [14].
Figure 3 represent the centralized procedure for marketing authorization.

Decentralised Procedure

In order to obtain marketing authorizations in several member states, the

centralised procedure is not mandatory; in such case the decentralized procedure is
to be used. An application is submitted to competent authorities of each of the
member states, where a marketing authorization is to be sought. The information
like quality, efficacy, safety, administrative information shall be submitted and a
list of all Concerned Member States (CMSs) and one member state to act as
Reference Member State (RMS). A draft assessment report on the medicinal
product is prepared and the CMSs and the RMS validate the application within a
time frame of 14 days. The RMS prepare draft summary of product characteristics,
labeling and package leaflet within 120 days. This report can be approved within
90 days. However, if a medicinal product is supposed to cause potential serious
risk to public health, CMS(s) will inform to other CMS, RMS and applicant and
further decision in this regard is taken within 30 days. Within 60 days of the
communication of the points of disagreement, all member states reach to an
agreement on the action to be taken. After reaching to an agreement of the member
states, the RMS records the agreement and informs to the applicant. However, if
the member states could not reach an agreement, then CHMP intervenes and take a
final decision keeping in view of the written or oral explanations of the
applicant[15,16,17,18]. Figure 4 represent the decentralized procedure for marketing
authorization in EU.

National Procedure

This type of authorization is granted on country-by-country basis by the competent

authorities, in each member state. Products only intended for one market and not
obliged to use the centralized procedure[19].

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)[20]. 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 [21].

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[22].

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 [22,23,24,25].

Drug Aproval 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 [26].

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[27,28]. 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 [29,30].

Drug Aproval Process In India

The Drug and Cosmetic Act 1940 and Rules 1945 were passed by the India's
parliament to regulate the import, manufacture, distribution and sale of drugs and
cosmetics. The Central Drugs Standard Control Organization (CDSCO), and the
office of its leader, the Drugs Controller General (India) [DCGI] was established.
In 1988, the Indian government added Schedule Y to the Drug and Cosmetics
Rules 1945. Schedule Y provides the guidelines and requirements for clinical
trials, which was further revised in 2005 to bring it at par with internationally
accepted procedure. The changes includes, establishing definitions for Phase I–IV
trials and clear responsibilities for investigators and sponsors [31]. The clinical trials
were further divided into two categories in 2006. In one category (category A)
clinical trials can be conducted in other markets with competent and mature
regulatory systems whereas the remaining ones fall in to another category
(category B) Other than A. Clinical trials of category A (approved in the U.S.,
Britain, Switzerland, Australia, Canada, Germany, South Africa, Japan and
European Union) are eligible for fast tracking in India, and are likely to be
approved within eight weeks. The clinical trials of category B are under more
scrutiny, and approve within 16 to 18 weeks [32].

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. To determine the maximum tolerated dose in
humans, adverse reactions, etc. on healthy human volunteers, Phase I clinical trials
are conducted. The therapeutic uses and effective dose ranges are determined in
Phase II trials in 10-12 patients at each dose level [32]. The confirmatory trials
(Phase III) are conducted to generate data regarding the efficacy and safety of the
drug in ~ 100 patients (in 3-4 centers) to confirm efficacy and safety claims. 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 [32,33,34,35].
The new drug registration (using form # 44 along with full pre-clinical and clinical
testing information) is applied after the completion of clinical trials. The
comprehensive information on the marketing status of the drug in other countries is
also required other than the information on safety and efficacy. The information
regarding the prescription, samples and testing protocols, product monograph,
labels, and cartons must also be submitted [36]. The application can be reviewed in a
range of about 12-18 months. Figure 10 represents the new drug approval process
of India. 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 [33,37].

The drug approval process varies from one country to another. In some countries,
only a single body regulates the drugs and responsible for all regulatory task such
as approval of new drugs, providing license for manufacturing and inspection of
manufacturing plants e.g. in USA, FDA performs all the functions. However in
some counties all tasks are not performed by a single regulatory authority, such as
in India, this responsibility is divided on Centralised and State authorities. 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 (Table 1).

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. Similarly, the format used for the presentation of
dossier submitted for approval of drug is also different. In some countries like as in
USA, EU, and Japan , it is mandatory that the dossier prepared in CTD format,
however, in some countries it is optional such as in India.

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. For the purpose of harmonisation, the International Conference
on Harmonisation (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.

References

1.Hörner A., Comparison of a global submission of new biological entity and a

new chemical entity – strategic decisions and criteria for implementation
(2005) http://www.dra.uni-bonn.de/hoerner. (assessed on March 09th 2010).

2. Ng R., Drugs: from Discovery to Approval

(2004) http://www.pharmatext.org/2008/06/drugs-from-discovery-to-approval.html

3.Wang H., Wang C.,Yu W., Hsu S, Huang Y, Lin Y., Leu Y. And Lee C. “From
Pharmacovigilance to Pharmacovigilance Planning--The System Building for Safe
Medication” Journal of Food and Drug Analysis. 2007; 15:377-386.

4.Significant Dates in U.S. Food and Drug Law

History,http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm12830
5.htm (assessed on March 09th 2010).

5. Lipsky M.S. and Sharp L.K., “From Idea to Market: The Drug Approval
Process” J Am Board Fam Pract. 2001; 14:362–367.

6. Stringer S., “What Has Been Happening With Over-the-Counter Drug

Regulation” Food and Drug Law Journal. 1998; 5:633-91.

7. Martinez L.J., “FDA Overview: An Overview of the Drug Approval Process”

Research Initiative Treatment Action (RITA), 2002: 8.

8.CFR: Title 21, Food and Drugs: Chapter I--Food and Drug: PART 312--
Investigational New Drug
Applicationhttp://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html (ass
essed on March 09th 2010).

9. Investigational New Drug Application (IND)

http://www1.pointcross.com/source/ddg/steps/ind/index.html(assessed on March
09th2010).
10. Fernandez D.S., Huie J., Hsu J., “The Interface of Patents with the Regulatory
Drug Approval Process and How Resulting Interplay Can Affect Market Entry”
Handbook of Best Practices. 965-971.

11.Meadows, M. The FDA’s Drug Review Process: Ensuring Drugs are Safe and
Effective (2002).http://www.fda.gov/fdac/features/2002/402_drug.html) (assessed
on December 14th 2009).

12.Boas V.M.I. and Tharp P.C.,“The Drug Approval Process in the U.S., Europe,
and Japan” J Managed Care Pharm 1997; 3: 459-465.

13.Commission Directive 2005/28/EC: Laying down principles and detailed

guidelines for good clinical practice as regards investigational medicinal products
for human use, as well as the requirements for authorisation of the manufacturing
or importation of such
products http://eurlex.europa.eu/LexUriServ/LexUriServ.do?
uri=OJ:L:2005:091:0013:... . (assessed on May 13th 2010).

14.http://www.lsnewscr.sgs.com/lsnewscr/lsnewscr-december-
issue/marketingauthorization-procedures-in-the-european-union-lsnewscr.htm.
(assessed on May 13th 2010).

15. Ghalamkarpour A., Marketing Authorization Procedures in the European

Union – Making the Right Choice
(2009).http://www.lsnewscr.sgs.com/lsnewscr/lsnewscr-december-
issue/marketing-a... (assessed on May 11th 2010).

16. http://www.seoho.biz/GMP_Quick_Search/Data/2.%20European
%20Documents/2.4.... (assessed on October 21st 2009).

17. European Commission: The Notice to Applicants; Volume 2A; Procedures for
marketing authorisation-2005,http://ec.europa.eu/health/files/eudralex/vol-
2/a/vol2a_chap1_2005-11_en... (assessed on May 21st 2010).

18. Marketing Authorization Procedures in the European Union – Making the

Right Choicehttp://www.lsnewscr.sgs.com/lsnewscr/lsnewscr-december-
issue/marketing-authorization-procedures-in-the-european-union-lsnewscr.htm
(assessed on May 27th 2010).

19.Davis H., An overview of the licensing process as it applies to medicinal

products in the
UKhttp://www.ukmi.nhs.uk/Med_info/licensing_process.pdf. (assessed on May
13th 2010).
20.European Commission: Notice to Applicants: Volume 2A; Procedures for
Marketing Authorisation; Chapter 2; Mutual
Recognition http://www.imb.ie/images/uploaded/documents/Chap2NTA.pdf . (asse
ssed on May 08th 2010).

21. http://www.alzheimereurope.org/index.php/EN/OurResearch/Understanding-
dementia-research/Clinical-trials/Phases-of-clinical-trials. (assessed on May
19th 2010).

22.Deng R. and Kaitin K.I., “The Regulation and Approval of New Drugs in
China” Drug Information Journal. 2004; 37:29-39.

23.Zhen L.H., “The drug registration application” J Pharm Pharmaceut Sci. 2003;
6(2):211-214.

24.SFDA Order No. 28:Provisions for Drug

Registrationhttp://eng.sfda.gov.cn/cmsweb/webportal/W45649039/A64028429.ht
ml(assessed on June 09th 2010).

25.Drug Administration Law of the People's Republic of

Chinahttp://eng.sfda.gov.cn/cmsweb/webportal/W45649037/A48335975.html(asse
ssed on March 19th 2010).

26.A History of Therapeutic Goods Regulation in

Australia http://www.tga.gov.au/about/tghistory.pdf (assessed on July 11th2010).

27.The Australian Clinical Trial Handbook:A simple, practical guide to the

conduct of clinical trials to International standards of Good Clinical Practice (GCP)
in the Australian
context- 2006, http://www.tga.gov.au/ct/cthandbook.pdf. (assessed on October
01st 2009).

28.Clinical Trials at a Glance: Access to unapproved therapeutic

goods http://www.tga.gov.au/ct/index.htm. (assessed on October 08th 2009).

29.Australian Regulatory Guidelines for Prescription Medicines (ARGPM)-

2003 http://www.tga.gov.au/pmeds/argpm.htm.(assessed on October 08 th 2009).

30.Consultation Paper: Requirements for the Prescription Medicine Streamlined

Submission Process-2010 (http://www.tga.health.gov.au/pmeds/consult/cons-
pmssp-submission-pfizer.pdf. )(assessed on June 05th 2010).

31.http://www.clinpage.com/article/indias_regulation_timeline/C9. (assessed on
February 24th 2010).
32.http://infochangeindia.org/200909177947/Health/Analysis/Trial-by-fire.html.
(assessed on February 24th 2010).

33.Bhatt A. “Clinical trials in India: Pangs of globalization” Indian J Pharmacol.

2004; 36(4):207-208.

34.Kumar S., Drug Approval Process- USA vs INDIA (2010)

http://www.pharmainfo.net/santosh-kumar-jh/drug-approval-process-usa-vs-india. 
(assessed on May 16th 2010).

35.http://www.expresspharmaonline.com/20021121/drugstud.shtml. (assessed on
February 16th 2010).

36.http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf. (assessed on February
24th 2010).

37. The Drugs and Cosmetics Acts 1940 and Rules 1945. Page no. 156-
161http://cdsco.nic.in/html/Copy%20of%201.%20D&CAct121.pdf (assessed on
May 21st 2010)

Table 1. Comparison of Drug approval process.

Country Time for Regulatory Time for Evaluation of MAA

Approval of MAA Fee
CTA/IND Application
Australi 120 day 50 days $192,400
a
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.
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 Authorizat

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

Figure 6: New Drug Registration Process of China
Figure 7: Clinical Trial Authorization Process of Australia under CTX
Scheme
NDA-New Drug Application, DSEB-Drug Safety and Evaluation Branch, TGA-
Therapeutic Goods Administration, ADEC-Australian Drug Evaluation Committee

Figure 8: New Drug Registration Process of Australia

IND-Investigational New Drug, DCGI-Drug Controller General of India, CDSCO-
Centre for Drug Standards Control organization.

Figure 9: New Drug Registration Process of India.