IAJPS 2018, 05 (08), 7251-7263 Burri Padmaja et al ISSN 2349-7750

CODEN [USA]: IAJPBB ISSN: 2349-7750

INDO AMERICAN JOURNAL OF

PHARMACEUTICAL SCIENCES
http://doi.org/10.5281/zenodo.1341334

Available online at: http://www.iajps.com Research Article

DOSSIER PREPARATION REQUIREMENTS FOR GENERIC

DRUGS OF USA, EUROPE & INDIA
Burri Padmaja*, M. V. Nagabhushanam, Brahmaiah Bonthagarala, D.
Nagarjuna Reddy, G.Ramakrishna
Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of
Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India-522002.
Abstract:
Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is
acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant
differences in the dossier submission requirements in these countries. This study put forth the differences in
registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved
under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the
generic drug approval process. For marketing authorization of the generic medicinal product in Europe, the
applicant should submit abridged application to the relevant authority. The ability to accommodate country specific
requirements and understand regulatory differences will have a substantial impact on the success of its multi
country submissions strategy. Generic manufacturers must file an Abbreviated New Drug Submission (ANDS), and
the CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of
health and family welfare, Government of India. Medicinal products are highly regulated in the European Union
(EU) and are subject to a separate, complicated system of approval procedures.
Keywords: CTD, Generic drug, CDSCO, Bioequivalence, ANDS.
* Corresponding author:
Burri Padmaja*, QR code
II/II M.Pharmacy, Department of Pharmaceutical
Management and Regulatory Affairs,
Hindu College of Pharmacy, Amaravathi Road,
Guntur, Andhra Pradesh, India-522002.

Please cite this article in press Burri Padmaja et al., Dossier Preparation Requirements for Generic Drugs of
USA, Europe & India., Indo Am. J. P. Sci, 2018; 05(08).

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1. INTRODUCTION: samples of finished product or related substances and

1.1. COMMON TECHNICAL DOCUMENT reagents necessary to perform analyses of finished
(DOSSIER) product as described in that dossier. The content and
Dossier is a file document submitted for the approval format of the dossier must follow rules as defined by
of new drug or drug product. It is submitted in form the competent authorities. For example, since year
of CTD. CTD is a harmonized format (template) for 2003, the authorities in the United States, the
presenting data in the ICH regions. In some countries, European Union and Japan ask for the Common
it is optional. The process of reviewing & assessing Technical Document (CTD) format, and more
dossier to support a medicinal product in view of its recently, its electronic version - the electronic
marketing (also called licensing, registration, Common Technical Document (eCTD).
approval, etc.), obviously finalized by granting of a
document is called marketing authorization. This The application is filed with the competent drug
process is performed within a legislative framework regulatory authority in the concerned country, which
which defines the requirements necessary for can be either an independent regulatory body or a
application to the concerned (competent) regulatory specialized department in the ministry of health. In
authority, details on the assessment procedure (based accordance with local legislation, the resulting
on quality, efficacy and safety criteria) and the document allowing to the applicant to market the
grounds for approval or rejection of the application, product may be more detailed (in addition to data
and also the circumstances where a marketing identifying the product and its holder it may contain
authorization already granted may be withdrawn, addresses of all manufacturing sites, appended
suspended or revoked [1,2]. labeling, artwork of packaging components, etc.)
until a one-page document called certificate of
Dossier is a file document submitted based on the registration (and containing minimal data identifying
requirement of regulatory agency for the approval of the product and its source).
drug product. It is essential to submit dossier file in
the form of common technical document in USA and 1.2. INTRODUCTION TO USFDA [3]:
EUROPE. Generic drugs are approved under ANDA The FDA is the government agency responsible for
submission. An Abbreviated New Drug Application reviewing, approving and regulating medical
(ANDA) is an application for a U.S. generic drug products, including pharmaceutical drugs and
approval for an existing licensed medication or medical devices. It also regulates various other
approved drug. The ANDA contains data which when products, including food, cosmetics, veterinary drugs,
submitted to FDA's Centre for Drug Evaluation and radiation-emitting products, biological products
Research, Office of Generic Drugs, provides for the and tobacco.
review and ultimate approval of a generic drug
product. Once approved, an applicant may Protecting public health is a key priority of the FDA,
manufacture and market the generic drug product to and for good reason. Tens of millions of Americans
provide a safe, effective, low cost alternative to the rely on prescription and over-the-counter drugs to
American public. The European Medicines Agency stay healthy, with as many as 3 billion prescriptions
(EMA) is a European agency for the evaluation of written each year. Safety concerns prompt the FDA
medicinal products. The EMA operates as a to pull one to two drugs and six to eight medical
decentralized scientific agency of the European devices from the market annually.
Union and is responsible for the protection and
promotion of human and animal health, specifically All medications and medical devices come with
through the coordination of evaluation and inherent risks, but it is the FDA’s duty to address
monitoring of centrally authorized products and serious risks that can be avoided and managed.
national referrals, developing technical guidance and Before any drug or medical device can gain approval
providing scientific advice. to be sold in the United States, it must first meet the
FDA’s regulatory standards. The FDA reviews the
The application dossier for marketing authorization is safety and effectiveness of medical products not only
called New Drug Application (NDA) in the USA or before they are approved, but also after they are sold
Marketing Authorization Application (MAA) in the to consumers and used.
European Union and other countries, or simply
registration dossier. Basically, this consists of a But FDA approval does not necessarily mean that a
dossier with data proving that the drug has quality, product is safe, or that its effectiveness has been
efficacy and safety properties suitable for the confirmed in a clinical trial. The FDA clears some
intended use, additional administrative documents, medical products if the manufacturer can prove they

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are substantially like a product already on the market. In its first two decades, the Agency recommended the
Even with a system in place to ensure a new authorisation of a total of 975 human and 188
product’s safety and minimize its risks, unexpected veterinary medicines.
complications can arise. If adverse event reports or EMA’s success is based on cooperation within
post-marketing surveillance indicate that a medical the European medicines regulatory network – a
product is causing preventable injuries to consumers, unique partnership between the European
the FDA can coordinate with the product’s Commission, the medicines regulatory authorities in
manufacturer to issue a recall. the European Economic Area countries, and
EMA. Working together has encouraged the
1.3.EUROPEAN MEDICINES AGENCY [4]: exchange of knowledge, ideas and best practices, to
Founded in 1995, the European Medicines Agency ensure the highest standards in medicines regulation.
(EMA) has worked across the European Union (EU) Today, seven EMA scientific committees and more
and globally to protect public and animal health by than 30 working parties provide scientific expertise
assessing medicines to rigorous scientific standards for the regulation of medicines by drawing on a pool
and by providing partners and stakeholders with of several thousand European scientific experts from
independent, science-based information on the network.
medicines.
1.4. CENTRAL DRUG STANDARD CONTROL
EMA has a 20-year track record ORGANIZATION [5]:
of ensuring efficacy and safety of human and The Central Drugs Standard Control Organization
veterinary medicines across Europe, and promoting (CDSCO) is the Central Drug Authority for
research and innovation in the development of discharging functions assigned to the Central
medicines. Government under the drugs and cosmetic act.
CDSCO has 6 zonal offices, 4 sub zonal offices
and13 port offices and several labs under control.

ROLES AND RESPONSIBILITIES:

CDSCO stands for Central Drugs Standard Control regulatory agency which approves any new chemical
Organization. CDSCO is a licensing authority, a entity (drug) which is to be imported to India.

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Authority: Who is Who? 4. Monitoring of quality of Drugs & Cosmetics,

CDSCO is controlled and governed by Directorate manufactured by respective state units and those
General of Health Services which comes under marketed in the state.
ministry of health and family welfare, Government of 5. Investigation and prosecution in respect of
India. The headquarter of the Central Drugs Standard contravention of legal provisions.
Control Organization is located at New Delhi, while 6. Administrative actions.
it has multiple zonal offices throughout India. 7. Pre- and post- licensing inspection
CDSCO also works in close context with Central 8. Recall of sub-standard drugs.
Drug Laboratories to perform quality control tests.
To regulate imported drugs as authority, the CDSCO 2.DOSSIER PREPARATION REQUIREMENTS
works with the Drugs Technical Advisory Board and FOR US GENERIC DRUGS5,6:
the Drugs Consultative Committee, while the Central
Drugs Laboratory undertakes testing of such drugs. Source: http:/ /www.fda.gov/cder/org.htm
The central authorities are responsible for approval of
new drugs, clinical trials in the country, laying down DEFINITION:
the standards for drugs, control over the quality of A drug product that is comparable to a
imported drugs, coordination of the activities of State brand/reference listed drug product in a dosage form,
Drug Control Organizations and providing expert strength, route of administration, quality and
advice with a view of bringing about the uniformity performance characteristics and intended use.
in the enforcement of the Drugs and Cosmetics Act.
The state authorities on the other hand are concerned WHEN GENERIC DRUGS CAN BE
with the regulation of manufacture, sale and MARKETED:
distribution of Drugs licensing drug testing 1)after patent and exclusivity protection ends.
laboratories, approving drug formulations for
manufacture, carrying out pre- and post-licensing 2)patent owner waives its rights, and
inspections, and overseeing the manufacturing
process, for drugs manufactured by respective state 3)FDA requirements are met.
units and those marketed in the state. These
authorities are formed under the Drug and Cosmetics WHAT ARE THE BASIC GENERIC DRUG
Act 1940 and Rules 1945. REQUIREMENTS?
Functions undertaken by the central authority can
be summarized as: Same active ingredients
1. Laying down standards of drugs, cosmetics, Same route of administration
diagnostics and devices.
2. Laying down regulatory measures, amendments to
Same dosage forms
Acts and Rules.
3. To regulate market authorization of new drugs.
Same strength
4. To regulate clinical research in India.
5. To approve licenses to manufacture certain
Same condition of use
categories of drugs as Central Licence approving
Authority i.e. for Blood Banks, Large Volume Par-
Inactive ingredients already approved in a similar
enterals and Vaccines & Sera.
6. To regulate the standards of imported drugs. NDA
7. Work relating to the Drugs Technical Advisory
Board (DTAB) and Drugs Consultative Committee ANDA REQUIREMENTS7:
(DCC). 1)labelling
8. Testing of drugs by Central Drugs Labs 2)pharm /TOX
9. Publication of Indian Pharmacopoeia. 3)chemistry
Functions undertaken by the state authorities can 4)manufacturing
be summarized as: 5)controls
6)microbiology
1. Licensing of drug manufacturing and sales 7)inspection
establishments 8)testing
2. Licensing of drug testing laboratories. 9)bioequivalence
3. Approval of drug formulations for manufacture.

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LABELLING: preclinical (animal) and clinical (human) data to

establish safety and effectiveness. Instead, generic
 Same as brand name labelling applicants must scientifically demonstrate that their
 May differ in excepients and product description product is bioequivalent (i.e., performs in the same
manner as the innovator drug). One way scientists
PHARM/TOX: demonstrate bioequivalence is to measure the time it
 All the active ingredients must be approved in takes the generic drug to reach the bloodstream in 24
either the reference listed drug or the similar to 36 healthy, volunteers. This gives them the rate of
NDA in same or higher levels. absorption, or bioavailability, of the generic drug,
 Generic focus- is there anything unique to using which they can then compare to that of the innovator
these ingredients in the proposed generic. drug. The generic version must deliver the same
amount of active ingredients into a patient's
CHEMISTRY, MANUFACTURING, bloodstream in the same amount of time as the
CONTROL: innovator drug.
 components and control
 manufacturing and control Using bioequivalence as the basis for approving
generic copies of drug products was established by
 Batch formulations and records
the "Drug Price Competition and Patent Term
 Descriptions of facilities
Restoration Act of 1984," also known as the
 Specifications and testing Waxman-Hatch Act. This Act expedites the
 Packaging availability of less costly generic drugs by permitting
 Stability FDA to approve applications to market generic
versions of brand-name drugs without conducting
MICROBIOLOGY: costly and duplicative clinical trials. At the same
Assure that sterility of the product through the time, the brand-name companies can apply for up to
manufacturing process-especially in the injectable five additional years longer patent protection for the
drug products. new medicines they developed to make up for time
lost while their products were going through FDA's
INSPECTION AND TESTING: approval process. Brand-name drugs are subject to
Assure the adherence to and authenticity of the data the same bioequivalence tests as generics upon
submitted in the application. reformulation.
Assure manufacturing facility are in compliance with
cGMP. The Office of Generic Drugs home page provides
additional information to generic drug developers,
Assure BE sites are in compliance with cGMP. focusing on how CDER determines the safety and
An Abbreviated New Drug Application (ANDA) bioequivalence of generic drug products prior to
contains data which when submitted to FDA's Centre approval for marketing. Generic drug application
for Drug Evaluation and Research, Office of Generic reviewers focus on bioequivalence data, chemistry
Drugs, provides for the review and ultimate approval and microbiology data, requests for plant inspection,
of a generic drug product. Once approved, an and drug labelling information.
applicant may manufacture and market the generic
drug product to provide a safe, effective, low cost Through an Abbreviated new drug application
alternative to the American public7. (ANDA) process, applicant may get FDA approval
for a generic drug without conducting clinical trials if
A generic drug product is one that is comparable to the drug is bioequivalent to the branded (innovator)
an innovator drug product in dosage form, strength, drug. All generic drugs approved by FDA have the
route of administration, quality, performance same high quality, strength, purity and stability as
characteristics and intended use. All approved brand name drugs.
products, both innovator and generic, are listed in TYPES OF ANDA8:
FDA's Approved Drug Products with Therapeutic ParaI
Equivalence Evaluations (Orange Book). ParaII
ParaIII
Generic drug applications are termed "abbreviated" Para IV:
because they are generally not required to include

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Fig-1-Types of ANDA

Fig-2- ANDA Application Process

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2.1. EMA – MARKETING DRUG European Generics Association (EGA)

AUTHORIZATION APPLICATION (MAA)9 The EGA is the official representative body of the
www.ema.europa.eu European generic and pharmaceutical industry, which
The EU has one of the most highly regarded is at the forefront of providing high-quality
regulatory systems in the world. The system affordable medicines to millions of Europeans and
comprises of European parliament, the council of stimulating competitiveness and innovation in the
ministers, and the European Commission. EU pharmaceutical sector.
consists of 27 member states: Austria, Belgium,  EGA represents generic pharmaceuticals
Bulgaria, Cyprus, Czech Republic, Denmark, companies and their subsidiaries from
Estonia, Finland, France, Germany, Greece, Hungary, throughout Europe, either directly or through
Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, national associations.
Netherlands, Poland, Portugal, Romania, Slovakia,  The EGA and its members work with the
Slovenia, Spain, Sweden, and the United Kingdom European national governments and the EU
and three countries which are member of European institutions to develop affordable solutions for
Free Trade Agreement (EFTA) Iceland, Norway, and pharmaceutical care and to increase Europe ‘s
Liechtenstein.[8] These EFTA members are those competitive strength in the global pharmaceutical
countries which were unable to join rest of the 27 medicines market.
member states as common market. These three EFTA  For the Marketing Authorization of Generic
member countries along with 27 EU member states, medicinal product in Europe, the applicant
comprises of the European Economic Area (EEA). should submit Abridged application to the
The European Medicines Agency is a decentralized authority.
agency of the European Union, located in London.[8]  Marketing authorization for a pharmaceutical
The Agency is responsible for the scientific product in more than one country in the
evaluation of medicines developed by pharmaceutical European Union must currently be applied for
companies for use in the European Union and through one of two procedures: either the
applications for European marketing authorizations ―Centralized Procedure or the ―Mutual
for both human and veterinary medicines (centralized Recognition Procedure (MRP). A third, the
procedure). Under the centralized procedure, ―Decentralized Procedure, came into force with
companies submit a single marketing-authorization the newly revised EU pharmaceutical Directive
application to the Agency. Once granted by the in November 2005.
European Commission, a centralized (or MARKETING AUTHORIZATION
“Community”) marketing authorization is valid in all PROCEDURES:
European Union (EU) and EEA-EFTA states Authorization of medicines is done by four
(Iceland, Liechtenstein and Norway). The European procedures:
parliament approves the laws together with the  Centralized Procedure
council of ministers. The council of ministers is the  Mutually Recognition Procedure
voice of Member states and is responsible for  Decentralized Procedure
enactment of directives.  National Procedure
MODULE 1 - ADMINISTRATIVE INFORMATION9,10 :

CTD EU CTD
1.0 Cover Letter
1.1 Comprehensive table of content
1.2 Application Form
1.3 Product Information
1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet
1.3.2 Mock-up
1.3.3 Specimen
1.3.4 Consultation with Target Patient Groups
1.3.5 Product Information already approved in the Member States
1.3.6 Braille
1.4 Information about the Experts
1.4.1 Quality
1.4.2 Non-clinical
1.4.3 Clinical

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1.5 Specific Requirements for different types of applications

1.5.1 Information for bibliographical applications
1.5.2 Information for Generic, “Hybrid” or Bio-similar Applications
1.5.3 (Extended) Data/Market Exclusivity
1.5.4 Exceptional Circumstances
1.5.5 Conditional Marketing Authorisation
1.6 Environmental risk assessment
1.6.1 Non-GMO
1.6.2 GMO
1.7 Information relating to Orphan Market Exclusivity
1.7.1 Similarity
1.7.2 Market Exclusivity
1.8 Information relating to Pharmacovigilance
1.8.1 Pharmacovigilance System
1.8.2 Risk-management System
1.9 Information relating to Clinical Trials
Responses to Questions
Additional data

2.2. CDSCO (central drug standards control generics sector and incentives for generic
organization)11 prescribing/dispensing are required to increase the
A generic drug (generic drugs, short: generics) is market share of generics.
a drug defined as "a drug product that is 3. THE COMMON TECHNICAL
comparable to brand/reference listed drug product DOCUMENT (CTD)12:
in dosage form, strength, route of administration, The Common Technical Document (CTD) is a
quality and performance characteristics, and set of specification for application dossier for the
intended use. It has also been defined as a term registration of Medicines and designed to be used
referring to any drug marketed under its chemical across Europe, Japan and the United States. It is
name without advertising. A generic drug must an internationally agreed format for the
contain the same active ingredients as the original preparation of applications regarding new drugs
formulation. Per the U.S. Food and Drug intended to be submitted to regional regulatory
Administration (FDA), generic drugs are identical authorities in participating countries. It was
or within an acceptable bioequivalent range to the developed by the European Medicines Agency
brand-name counterpart with respect to (EMA, Europe), the Food and Drug
pharmacokinetic and pharmacodynamics Administration (FDA, U.S.) and the Ministry of
properties. A generic drug is identical--or Health, Labour and Welfare (Japan). The CTD is
bioequivalent--to a brand name drug in dosage maintained by the International Conference on
form, safety, strength, route of administration, Harmonisation of Technical Requirements for
quality, performance characteristics and intended Registration of Pharmaceuticals for Human use.
use. Although generic drugs are chemically The Common Technical Document is divided into
identical to their branded counterparts, they are five modules:
typically sold at substantial discounts from the 1. Administrative and prescribing information
branded price. Opportunities arising from 2. Overview and summary of modules 3 to 5
increased use of generics 3. Quality (pharmaceutical documentation)
4. Preclinical (Pharmacology/Toxicology)
Ensuring the sustainability of the generic 5. Clinical - efficacy (Clinical Trials)
medicines industry is one of the key elements in
maintaining broad access to medicines for all. To 4.GENERAL CONSIDERATIONS FOR
meet increasing demand from more patients who DOSSIER PREPARATION [9,10]
are living longer and expecting an improved  The CTD is only a format for submission of
quality of life, generic medicines offer quality information to CDSCO.
treatment at affordable prices.  Although adherence to overall CTD structure is
necessary, it should be noted that no guideline can
To ensure sustainability both investment in the cover all eventualities, and common sense and a clear

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focus on the needs of the regulatory authority for descriptive text and Times New Roman, 9 to 10-
assessor are the best guides to constructing an point font for table contents and text.
acceptable document. Therefore, applicants can  All abbreviations should be defined at the first
modify the format at some of the subsection levels, if instance they are used and listed at the end of the
needed to provide the best possible presentation of dossier.
the information, to facilitate the understanding and  References should be cited in accordance with the
evaluation. current edition of the uniform requirements for
 Text and tables should be prepared using margins manuscripts submitted to biomedical journals,
that allow the document to be printed clearly without International Committee of Medical Journal Editors
losing any information and the left-hand margin (ICMJE).
should be sufficiently large so that information is not 5.DIFFERENCES BETWEEN USFDA, EMA
obscured by the method of binding. AND CDSCO
 Font sizes for text and tables should be of a style
and size that are large enough to be easily readable.
Times New Roman, 12- point font is recommended

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6. RESULTS AND DISCUSSION: As per USFDA guidelines, to obtain approval for

INDIAN MARKET: ANDA the dossier shall contain the following
The CDSCO defined the procedure to obtain product information.
approval (dossier) With the following information. Product development details including formulation
For the existing molecule if a manufacturer wanted development, analytical development and stability
an approval then the firm should submit their studies details. A master batch record, process
application form along with manufacturing formula, validation protocol, testing procedures along with
brief manufacturing procedure, minimum 3 months specification, stability protocol etc need to be made
accelerated stability studies data, testing procedure ready prior to start of the batch.
with specification, technical competent staffs details
for manufacturing and testing, products label details, The same batch shall be subjected for bioequivalence
marketed products labelling information. studyalong with RLD, stability studies. While
executing this submission batch the manufacturing
Prior to grant of the dossier approval or product process shall be validated with stratified sampling
approval to manufacture and supply for an existing process. All the above mentioned documents are to
molecule, the staffs drug control department schedule be attached with dossier along with intended batch
for the manufacturing facility inspection to verify for record specifying the batch size, equipments to be
the Cgmp adherence of the revised schedule m. used for commercial manufacturing if its different
from the submission batch manufacturing. To file a
The manufacturing facility must have own testing ANDA and sanda the firm must tie up with an local
unit including microbiology section otherwise need to office in USA to liaison with FDA. All
establish with a commercial testing lab. communications from FDA are routed through local
office.
Every commercial batch must be tested as per IP if its
official in pharmacopoeia or as per in house EUROPE MARKET:
specification prior to distribution. As per ema guidelines, to obtain approval for EMA
the dossier shall contain the following information.
USA MARKET: Product development details including formulation

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development, analytical development and stability products to European Union and European
studies details. A master batch record, process Economic Area.” 10(1) 2011.
validation protocol, testing procedures along with 9. Technical bulletin by arash ghalamkarpour on”
specification, stability protocol Etc need to be made Marketing Authorisation Procedures In The
ready prior to start of the batch. Minimum two European Union-Making The Right Choice”.
batches need to be manufactured at the commercial Issue N*33/ December 2009.
batch size as exhibit/ submission batch. The same 10. Marketrealist.com/2016/04/challenges-
batch shall be subjected for bioequivalence study pharmaceutical-industry-japan/
along with reference product collected from market, 11. B.Sai Kumari, G.Sai Hanuja,
stability studies. M.V.Nagabhushanam, D.Nagarjuna Reddy,
While executing this submission batches the Brahmaiah Bonthagarala, Current Regulatory
manufacturing process shall be validated. The raw Requirements for Registration of Medicines,
materials and primary packing materials used shall be Compilation and Submission of Dossier in
free from TSE and BSE. All the above-mentioned Australian Therapeutic goods Administration,
documents are to be attached with dossier. To have International Journal of Advanced Scientific and
24 months as shelf life for the proposed product, the Technical Research , ISSN 2249-9954, Issue 6
the proposed product, the firm must submit at least volume 6, November-December 2016, 144-157.
12months real time stability study data. During 12. G.Sai Hanuja, B.Sai Kumari,
commercial supply if the firm decides to scale up the M.V.Nagabhushanam, D.Nagarjuna Reddy,
batch size, then that shall be routed through variation. Brahmaiah Bonthagarala, Regulatory
The product cant be approved until the patient Requirements for Registration of Generic Drugs
expires. Also in Europe to obtain marketing in “BRICS” Countries, International Journal of
authorization, the firm must submit at least 12 Pharmaceutical Science and Health Care, ISSN
months real time stability study data. During 2249 – 5738, Issue 6, Vol. 6 , November-
commercial supply if the firm decides to scale Up the December 2016, 20-40.
batch size, then that shall be routed through variation.
The product cannot be approved until the brand
patient expires. Also in Europe to obtain marketing
authorization, the firm must have a registered office
with in Europe which is operating full time basis.

7. REFERENCES:
1. www.regulatoryone.com2012/01/anda.html
2. www.fda.gov
3. www.ema.europa.eu/
4.www.prnewswire.com/news...../usagenericoutlook2
018
5. S.M.Shakeel, Shaik Salman Basha,
M.V.Nagabhushanam, D.Nagarjuna Reddy,
Brahmaiah Bonthagarala, Comparision of
Regulataory Requirements for Generic Drugs
Dossier Submission in United States and Canada,
International Journal of Pharmaceutical Science
and Health Care, ISSN 2249 – 5738, Issue 6,
Vol. 6 , November-December 2016, 1-19.
6. Shaik Salman Basha, S. M. Shakeel, M. V.
Nagabhushanam, D. Nagarjuna Reddy,
Brahmaiah Bonthagarala, The Assesment of
Current Regulatory Guidelines for Biosimilars-
A Global Scenario, World Journal of
Pharmaceutical Research, ISSN 2277– 7105,
volume 6, Issue 1, 351-369
7. www.gabionline.net/reports/generics-market-
share-in-europe
8. Review article by santhosh kumar narla,
“Marketing Authorization of Human Medicinal

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