Jawahar.N et al /J. Pharm. Sci. & Res. Vol.

9(10), 2017, 1943-1952

Regulatory Requirements for the Drug Approval

Process in US, Europe and India
Jawahar.N1*, Vidhya Lakshmi. T2
1
Department of Pharmaceutics,
2
Pharmaceutical Drug Regulatory Affairs Division,
JSS College of Pharmacy,Udhagamandalam -643001, Tamilnadu, India.
Jagadguru Sri Shivarathreeshwara University, Mysore

Abstract:
In the Current scenario, different countries have to follow different regulatory requirements for marketing authorization
application (MAA) approval of new drug. In this present work, we studied the drug approval process and regulatory
requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug
Standard Control Organisation (CDSCO).
Key Words: Drug Approval, Regulatory Requirements, USFDA, EMA, INDIA

INTRODUCTION:  Phase III - Confirmatory trial - Confirmation of

Currently different countries have to follow different therapeutic benefits
regulatory requirements for approval of new drug. For  Phase IV - Post marketing trial - Studies done
marketing authorization application (MAA) a single after drug approval[2,3,4].
regulatory approach is applicable to various countries is After NDA received by the agency, it undergoes a technical
almost a difficult task. Therefore it is necessary to have screening. This evaluation ensures that sufficient data and
knowledge about regulatory requirement for MAA of each information have been submitted in each area to justify
country [1]. The basic regulation can be understood from “filing” the application.
FIGURE 1. At the conclusion of the review of an NDA, there are 3
New drug application (NDA) is an application submitted to possible actions that can send to sponsor:
the respective regulatory authority for permission to market  Not approvable- in this letter list of deficiencies
a new drug. To obtain this permission a sponsor submits and explain the reason.
preclinical and clinical test data for analyzing the drug  Approvable - it means that the drug can be
information, description of manufacturing procedures. approved but minor deficiencies that can be
Different Phases of clinical trials: corrected like-labeling changes and possible
 Pre clinical study - Mice, Rat, Rabbit, Monkeys request commitment to do post-approval studies.
 Phase I - Human pharmacology trial - estimation  Approval- it state that the drug is approved.
of safety and tolerability If the action taken is either an approvable or a not
 Phase II - Exploratory trial - estimation of approvable, then the regulatory body provides applicant
effectiveness and short term side effects with an opportunity to meet with agency and discuss the
deficiencies[5,6].

DRUG CLINICAL TRIALS

DRUG MARKETING
DEVELOPMENT; IN HUMAN
DISCOVERY APPLICATION
MANUFATURING

COMPLIANCE WITH REGULATORY REQUIREMENT IS

NECESSARY

FIGURE 1: Regulation of drug approval process

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DRUG APPROVAL PROCESS IN UNITED STATES

In 1820, the new era of USA drug regulation was started
with the establishment of U.S. Pharmacopoeia. In 1906, New drug application (NDA)
Congress passed the original Food and Drugs Act, which A new drug application (NDA) can be filed only when the
require that drugs must meet official standards of strength drug successfully passes all three phases of clinical trials
and purity [7]. However, in 1937, due to sulphanilamide and includes all animal and human data, data analyses,
tragedy, the Federal Food, Drug and Cosmetic Act (of pharmacokinetics of drug and its manufacturing and
1938) was enacted and added new provisions that new proposed labelling. The preclinical, clinical reports and
drugs must be shown safe before marketing. Further, in risk-benefit analysis (product's beneficial effects outweigh
1962, the Kefauver-Harris Amendment Act was passed its possible harmful effects) are reviewed at the Centre for
which require that manufacturers must prove that drug is Drug Evaluation and Research by a team of scientists. If
safe and effective (for the claims made in labelling) [8,9]. clinical studies confirm that a new drug is relatively safe
and effective, and will not pose unreasonable risks to
The United States has perhaps the world’s most stringent patients, the manufacturer files a New Drug Application
standards for approving new drugs. Drug approval (NDA), the actual request to manufacture and sell the drug
standards in the United States are considered by many to be in the United States [9,10].
the most demanding in the world. Generally approval of an NDA is granted within two years
The Food and Drug Administration (FDA) is responsible (on an average), however, this process can be completed
for protecting and promoting public health. Like general from two months to several years. The innovating company
drug approval process, FDA's new drug approval process is is allowed to market the drug after the approval of an NDA
also accomplished in two phases: clinical trials (CT) and and is considered to be in Phase IV trials. In this phase,
new drug application (NDA) approval. FDA approval new areas, uses or new populations, long-term effects, and
process begins only after submission of investigational new how participants respond to different dosages are explored.
drug (IND) application. FIGURE 2 describes the drug approval process in USA

Investigational New Drug (IND) Application DRUG APPROVAL PROCESS IN EUROPE

It’s an application filed to the FDA in order to start clinical In European union (EU), the medical products were
trials in humans if the drug was found to be safe from the approved for marketing at the National level initially. The
reports of Preclinical trials. The IND application should mutual recognization procedure was introduced in 1938
provide high quality preclinical data to justify the testing of and a single national review in case of
the drug in humans. Almost 85% of drugs are subjected to pharmaceutical/medicinal product for marketing
clinical trials, for which IND applications are filed. A firm authorization in EU’s countries was made feasible. The
or institution, called a Sponsor, is responsible for primary aim of this procedure was to create a united
submitting the IND application. standard for product review among national regulatory
A pre - IND meeting can be arranged with the FDA to authorities. In 1987, for high-technology or biologically
discuss a number of issues: derived products, the concentration procedure was
 The design of animal research, which is required established by directive 87/22, in which product assessment
to lend support to the clinical studies should be completed by Committee for Proprietary
 The intended protocol for conducting the clinical Medicinal Products (CPMP) besides the normal national
trial regulatory review. Further, in 1993, by council regulation
 The chemistry, manufacturing, and control of the (EEC) 2309/93, the concertration procedure was replaced
investigational drug. with centralised procedure, by which all the high-tech and
Such a meeting will help the Sponsor to organize animal biologically derived product was reviewed and granted
research, gather data, and design the clinical protocol based EU's wide marketing authorization by the EU's CPMP.
on suggestions by the FDA. Similarly, the drug approval process in European countries
The next step is phase I clinical trials (1-3 years) on human is also accomplished in two phases: clinical trial and
subjects (~100). The drug's safety profile and marketing authorization. A clinical trial application (CTA)
pharmacokinetics of drug are focused in this phase. Phase is filed to the competent authority of the state to conduct
II trials (2 years) are performed if the drug successfully the clinical trial within EU. The competent authority of that
passes phase I. To evaluate dosage, broad efficacy and member state evaluates the application. The clinical trials
additional safety in people (~300) are the main objective of are conducted only after the approval. The purpose and
the phase II. If evidence of effectiveness is shown in phase phases of clinical trials are similar as specified in FDA drug
II, phase III studies (3-4 years) begins. These phase III approval process. Figure 2 represent the clinical trial
concerns more about safety and effectiveness of drug from authorization process in EU.
data of different populations, dosages and its combination After completing of all three phases of clinical trial,
with other drugs in several hundred to about 3,000 peoples marketing authorization application (MAA) is filed
[8]
. including all animal and human data, its analyses, as well
as pharmacokinetics, manufacturing and proposed

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labelling. In the EU's countries, the company have a choice

of following regulatory procedures:
Applicant

Filing IND application to FDA

Application sent to the reviewer

Within 30 days after

Positive or no IND sealing date
response
Review
Conduct clinical
Negative
Within 60 days of announcing of
IND

Submit reports of clinical trials

Before one month from ending

of phase II clinical trial

Meeting to conduct Phase III clinical trials commence

phase III clinical trial
Before 9 to 12 months from NDA 
submission 
Pre NDA

Send to CDER Filing NDA to FDA

No
Inform the
Is application filable?
Check filability of application applicant

Yes

Send to reviewer

Within 180 days

+ve Issue marketing

Notify applicant Submit review
about deficiency report to CDER authorisation
-ve

+ve
Applicant submit amended Review report
application to FDA and FDA
review the amended -ve

Refused to applicant
FIGURE 2: Drug approval process in USA

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MAA Start of procedure (day 1)

Assessment report from (co)-

CHMP provides comments (day 115)
rappoteur (day 70)

CHMP forwards to applicant list

of questions (day 120) stop clock Submission of response by applicant
(day 121)

Joint assessment report from (co) –

Comments by CHMP (day
rappoteur (day 150)
170)

CHMP decision on need of oral

Oral explanation by applicant (day
explanation by applicant (day 180)
181) restart clock

Final draft of English SPC, leaflet and

CHMP opinion (day 210) labelling by applicant to co-rappoteur,
EMEA, CHMP (day 185)

FIGURE 3: Centralised procedure for marketing authorization in EU

Centralized Procedure and is for five years, however, the extension can be applied
The Committee for Human Medicinal Products (CHMP) to the EMEA three months before the expiration of this
evaluate the applications received by the EMEA. In view of period. FIGURE 3 represent the centralized procedure for
the applicant's preference, CHMP contracts out assessment marketing authorization.
work in one of the member states (the "rapporteur"). After Centralized process is compulsory for:
the complete assessment, the CHMP deliver opinion to EU  Those medicines which are derived from any
Commission within 210 days [11]. The EU Commission biotechnology processes, such as genetic
requests comments from other member states, if a positive engineering.
opinion from CHMP is received. The other member states  Those medicines which are intended for the
can respond in about 28 days. When a licence is treatment of Cancer, HIV/AIDS, diabetes,
recommended, a European Public Assessment Report neurodegenerative disorders or autoimmune
(EPAR) is produced and marketing authorisation is issued. diseases and other immune dysfunctions [12].
This authorisation is valid throughout the European Union

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 Medicines officially designated 'Orphan product characteristics, labelling and package leaflet within
medicines' (medicines used for rare diseases). 120 days. This report can be approved within 90 days.
However, if a medicinal product is supposed to cause
Decentralized Procedure potential serious risk to public health, CMS(s) will inform
In order to obtain marketing authorizations in several to other CMS, RMS and applicant and further decision in
member states, the centralised procedure is not mandatory; this regard is taken within 30 days. Within 60 days of the
in such case the decentralized procedure is to be used. An communication of the points of disagreement, all member
application is submitted to competent authorities of each of states reach to an agreement on the action to be taken [13,14].
the member states, where a marketing authorization is to be After reaching to an agreement of the member states, the
sought. The information like quality, efficacy, safety, RMS records the agreement and informs to the applicant.
administrative information shall be submitted and a list of However, if the member states could not reach an
all Concerned Member States (CMSs) and one member agreement, then CHMP intervenes and take a final decision
state to act as Reference Member State (RMS). A draft keeping in view of the written or oral explanations of the
assessment report on the medicinal product is prepared and applicant. FIGURE 4 represent the decentralized
the CMSs and the RMS validate the application within a procedure for marketing authorization in EU.
time frame of 14 days. The RMS prepare draft summary of

Applicant submits application to the RMS and CMS

70 days
RMS and CMS validates the application

RMS distributes the preliminary assessment report to the CMS

35 days

RMS sends preliminary assessment report and all comments of

the CMS to the applicant

Clock stops, applicant responds, clock runs 15 days

RMS sends draft assessment report to the CMS and applicant

90 days or less

CMS approve the assessment report

Marketing authorization in RMS and each of the CMS

FIGURE 4: Decentralised procedure for marketing authorization in EU

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Nationalized Procedure  Applicant submits identical dossier to all EU

The Nationalized procedure is one which allows applicants member states in which they want marketing
to obtain a marketing authorization in one member state authorization, including required information.
only.  As soon as one Member State decides to evaluate
 In order to obtain a national marketing the medicinal product (at which point it becomes
authorization, an application must be submitted to the "RMS"), it notifies this decision to other
the competent authority of the Member State. Member States (which then become the "CMS"),
 New active substances which are not mandatory to whom applications have also been submitted.
under Centralized procedure can obtain marketing  RMS issues a report to other states on its own
authorization under this procedure. findings.
 Timeline for this procedure is 210 Days  Generic industry is the major user of this type of
Mutual Recognition Procedure drug approval procedure.
The Mutual Recognition procedure allows applicants to  This process may consume a time period of 390
obtain a marketing authorization in the concerned member days.
states (CMS) other than the Reference member state FIGURE 5 represents the mutual recognition procedure for
(RMS), where the drug is previously approved [15]. drug approval process in EU

Applicant submits application to the RMS and CMS

RMS validates the application 90 days

RMS distributes assessment report to CMS

CMS validates the application

90 days

CMS approves the assessment report

Marketing authorization in each of the CMS

FIGURE 5: Mutual recognition procedure for drug approval process in EU

DRUG APPROVAL PROCESS INDIA and requirements for clinical trials, which was further
The Drug and Cosmetic Act 1940 and Rules 1945 were revised in 2005 to bring it at par with internationally
passed by the India's parliament to regulate the import, accepted procedure [16].
manufacture, distribution and sale of drugs and cosmetics. When a company in India wants to manufacture/ import a
The Central Drugs Standard Control Organization new drug it has to apply to seek permission from the
(CDSCO), and the office of its leader, the Drugs Controller licensing authority (DCGI) by filing in Form 44 also
General (India) [DCGI] was established. In 1988, the submitting the data as given in Schedule Y of Drugs and
Indian government added Schedule Y to the Drug and Cosmetics Act 1940 and Rules 1945. In order to prove its
Cosmetics Rules 1945. Schedule Y provides the guidelines efficacy and safety in Indian population it has to conduct

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clinical trials in accordance with the guidelines specified in 10-12 patients at each dose level. The confirmatory trials
Schedule Y and submit the report of such clinical trials in (Phase III) are conducted to generate data regarding the
specified format. efficacy and safety of the drug in ~ 100 patients (in 3-4
Rule- 122A of the Drug and Cosmetics Act says that the centers) to confirm efficacy and safety claims. Phase III
clinical trials may be waived in the case of new drugs trials should be conducted on a minimum of 500 patients
which are approved and being used for several years in spread across 10-15 centres, If the new drug substance is
other countries. not marketed in any other country.

Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act The new drug registration (using form # 44 along with full
1940 and Rules 1945 says for those drug substances which pre-clinical and clinical testing information) is applied after
are discovered in India all phases of clinical trials are the completion of clinical trials. The comprehensive
required. information on the marketing status of the drug in other
countries is also required other than the information on
Section 2.4 (b) of Schedule Y of Drugs and Cosmetics Act safety and efficacy. The information regarding the
1940 and Rules 1945 says that for those drug substances prescription, samples and testing protocols, product
which are discovered in countries other than India; the monograph, labels, and cartons must also be submitted.
applicant should submit the data available from other
countries and the licensing authority may require him to The application can be reviewed in a range of about 12-18
repeat all the studies or permit him to proceed from Phase months. Figure 5 represents the new drug approval process
III clinical trials [17]. of India. After the NDA approval, when a company is
allowed to distribute and market the product, it is
Demonstration of safety and efficacy of the drug product considered to be in Phase IV trials, in which new uses or
for use in humans is essential before the drug product can new populations, long-term effects, etc. are explored.
be approved for import or manufacturing of new drug by FIGURE 6 describes the drug approval process in INDIA.
the applicant by Central Drugs Standard Control
Organization (CDSCO). The regulations under Drugs and Through the International Conference on Harmonization
Cosmetics Act 1940 and its rules 1945, 122A, 122B and (ICH) process, the Common Technical Document (CTD)
122D and further Appendix I, IA and VI of Schedule Y, guidance has been developed for Japan, European Union,
describe the information required for approval of an and United States.
application to import or manufacture of new drug for
marketing [18]. Most countries have adopted the CTD format. Hence,
CDSCO has also decided to adopt CTD format for
The changes in the Drugs And Cosmetics Act includes, technical requirements for registration of pharmaceutical
establishing definitions for Phase I-IV trials and clear products for human use.
responsibilities for investigators and sponsors. The clinical
trials were further divided into two categories in 2006. In Stages of approval [20,21,22]:
one category (category A) clinical trials can be conducted 1. Submission of Clinical Trial application for evaluating
in other markets with competent and mature regulatory safety and efficacy.
systems whereas the remaining ones fall in to another 2. Requirements for permission of new drugs approval.
category (category B) Other than A. Clinical trials of 3. Post approval changes in biological products: quality,
category A (approved in the U.S., Britain, Switzerland, safety and efficacy documents.
Australia, Canada, Germany, South Africa, Japan and 4. Preparation of the quality information for drug
European Union) are eligible for fast tracking in India, and submission for new drug approval.
are likely to be approved within eight weeks. The clinical
trials of category B are under more scrutiny, and approve The drug approval process varies from one country to
within 16 to 18 weeks [19]. another. In some countries, only a single body regulates the
drugs and responsible for all regulatory task such as
An application to conduct clinical trials in India should be approval of new drugs, providing license for manufacturing
submitted along with the data of chemistry, manufacturing, and inspection of manufacturing plants e.g. in USA, FDA
control and animal studies to DCGI. The date regarding the performs all the functions. However in some counties all
trial protocol, investigator's brochures, and informed tasks are not performed by a single regulatory authority,
consent documents should also be attached. A copy of the such as in India, this responsibility is divided on
application must be submitted to the ethical committee and Centralised and State authorities. Some counties have two
the clinical trials are conducted only after approval of review processes as normal review process and accelerated
DCGI and ethical committee. review process as in USA, China etc. and some countries
have only a single review process as in India. Similarly, the
To determine the maximum tolerated dose in humans, format used for the presentation of dossier submitted for
adverse reactions, etc. on healthy human volunteers, Phase approval of drug is also different. In some countries like as
I clinical trials are conducted. The therapeutic uses and in USA, EU, and Japan , it is mandatory that the dossier
effective dose ranges are determined in Phase II trials in

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prepared in CTD format, however, in some countries it is optional such as in India.

APPLICANT

IND application filing to CDSCO head

quarters

Application to ethical committee

Examination by new drug division

Report of ethical committee

Detailed review by IND committee

If Positive

Recommendation to DCGI

Within 12 weeks

IND application approved

Clinical trials started

Application for new drug registration

to CDSCO

If not complete
Review by DCGI

If complete
Refused to grant license

LICENCE IS GRANTED

FIGURE 6: D rug approval process in INDIA

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TABLE 1: Principe difference between US, EU and INDIA

REQUIREMENTS US EU INDIA
Multiple agencies
 EMEA
Agency One agency USFDA One agency DCGI
 CHMP
 National health agencies
Multiple registration process
 Centralised (European
community)
 Decentralised (at least 2
Registration process One registration process member states) One registration process
 Mutual recognition (at
least 2 member states)
 National (1 member
state)
TSE/BSE study data Not required Required Required
Braille code is not required Braille code is required on Braille code is not required
Braille code
on labelling labelling on labelling
Post approval changes in Post variation in the approved
the approved drug: drug: Post approval changes:
Post approval changes  Minor  Type IA  Major
 Moderate  Type IB  Moderate
 major  Type II

REQUIREMENTS US EUROPE INDIA

Application ANDA/NDA MAA MAA
Debarment classification Required Not required Not required
Number of copies 3 1 1
Approval timeline 18 months 12 months 2 - 18 months
National fee (including
Under $2 million – NDA hybrid applications):
Fees application £103,059 50,000 INR
$1,520 – ANDA application Decentralised procedure
where UK is CMS:£99,507
Presentation eCTD and paper eCTD Paper
TABLE 2: Administrative requirements

TABLE 3: Manufacturing and control requirements

REQUIREMENTS US EUROPE INDIA

Number of batches 1 3 1
Packaging A minimum of 1,00,0000 Not required Not addressed
Not required at the time of
Process validation Required Required
submission
1 pilot scale or minimum of 2 pilot scale plus 1 lab
Batch size 1 lakh units whichever is batch or minimum of 1 lakh Pilot scale batch
higher units whichever is higher

DISCUSSION firstly files an application to conduct clinical trial, and only

Generally, the drug approval process comprised mainly the after the approval by the regulatory authority, the applicant
two steps, application to conduct clinical trial and conducts the clinical studies and further submits an
application to the regulatory authority for marketing application to the regulatory authority for marketing
authorization of drug. The new drug approval process of authorization of drug. In all countries, information
various countries is similar in some of the aspects whereas submitted to regulatory authorities regarding the quality,
it differs in some aspects. In most of the counties, sponsor safety and efficacy of drug is similar; however, the time,

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fee and review process of clinical trials and marketing 5. CDER Guidance: A review for OCRA US RAC Study,
www.fda.gov/cder/regulatory/applications/ind_page_1. html.
authorization application differs. For the purpose of Accessed on AUG 25, 2011.
harmonisation, the International Conference on 6. Clinical trial registration: a statement from the International
Harmonisation (ICH) has taken major steps for Committee of Medical Journal Editors. Med. J. Aust, 181, 2004, 293-
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7. Significant Dates in U.S. Food and Drug Law History,
application of technical guidelines and requirements. www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm12830
Through the International Conference on Harmonization 5.html. Assessed on March 09, 2010.
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9. Jawahar.N, Prashob Nair, A.Ramachandran ., Pharma Times, 2015,
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This step will ultimately reduce the need to duplicate work 10 Title 21, Food and Drugs: Chapter I--Food and Drug: PART 312--
carried out during the research and development of new Investigational New Drug Application
drugs. Therefore, harmonization of drug approval processes www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html,
Assessed on March 09, 2010.
either by ICH or WHO may be initiated at global level. 11. Jawahar.N., Nishit Shrivastava., Ramachandran., Baviya
The regulatory agency for US and INDIA is a single Priyadharshini.R., J. Pharm. Sci. & Res. 2015, 7(4), 219-225.
agency i.e. USFDA and CDSCO respectively, whereas in 12. U. Nitin Kashyap., Vishal Gupta., H. V. Raghunandan., J. Pharm.
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13. European Commission: The Notice to Applicants; Volume 2A;
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Europe also has multiple regulatory procedures when http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap1_2005-
compared to US and INDIA. The approval time in all the 11_en... Assessed on May 21, 2010.
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