A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

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ABOUT AUTHORS
1Veerendra Kr. Gautam*, 2Mohamad. Irfan
1Executive in Drug Regulatory Affairs Department; East African (India) Overseas
1 120 Suncity Business Tower,Sector-54, Gurgaon-122002 (Haryana).
2Research Associate; Jubilant Chemsys Ltd.
2D-12, Sector 59, Noida , Uttar Pradesh, India
1dra.veerendra.gautam@gmail.com;
1viren.gautam.dra@gmail.com 2mohd.irfan.ivar@gmail.com

Abstract : Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. There are basically two formats for dossier preparation i.e. ICH-CTD and ACTD. ICH-CTD followed by ICH countries as well as low economical or developing countries where as ACTD is followed by ASEAN countries. ACTD act as bridge between regulatory requirements of developed and developing countries. Also if both guidelines of CTD and ACTD can be harmonized then differences and variation between both guidelines can be minimized.

REFERENCE ID: PHARMATUTOR-ART-2527

PharmaTutor (Print-ISSN: 2394 - 6679; e-ISSN: 2347 - 7881)

Volume 5, Issue 10

Received On: 07/06/2017; Accepted On: 08/06/2017; Published On: 01/10/2017

How to cite this article: Gautam VK, Mohamad I; A Study of procedures for Dossier Preparation and their marketing authorisation in different countries of selected drug(s); PharmaTutor; 2017; 5(10); 8-22

INTRODUCTION
Dossier [1-4] The word 'Dossier' has the english meaning as a collection or file of documents on the particular subject, especially a file containing detailed information about a person or a topic. Any formulation is prepared for human use i.e. designated to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “Pharmaceutical product for human use”. Process of critiquing and assessing the dossier of pharmaceutical product containing its detailed about administrative, chemistry, preclinical & clinical information and the permission granted by the regulatory agencies of a country with a view to support its marketing or approval in a country is called as “Marketing approval or Registration” ,“Marketing Authorization or “ Product Licensing”.

“Registration Dossier” of the pharmaceutical product is a document that contains all technical data (administrative, quality, nonclinical, and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in European Union (EU) and other countries as simply Registration Dossier.

The International Conference on Harmonization (ICH) process has considerably harmonized on the organization of the registration of documents with the issuance of the Common Technical Document (CTD) guideline. This recommended format in the CTD guideline for registration applications has become widely accepted by regulatory authorities both within and beyond the ICH Regions.

Thus dossier is a file document that has to be submitted based on the requirement of the drug approval/ market authorization process. It is a comprehensive scientific document used to obtain worldwide licensing approval/ market authorization of a drug by diverse health authorities. Its creations, processing, compilation & dispatch to the field by a regulatory affairs department, is dependent upon many interrelated activities, the filling and authorization process in the emerging markets will be depends upon the region.

Globalization of the pharmaceutical industry has created the need to harmonize the recommendations for the development of new pharmaceuticals, as well as the regulatory requirements of various countries. Thus, a common format of submission will help in overcoming these hurdles. Through ICH process, the CTD’s guidance have been developed for Japan, European Union, and United States. Almost Most of the countries have adopted the CTD format.

 

COMMON TECHNICAL DOCUMENT (CTD) [5]
CTD is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, U.S.) and the Ministry of Health, Labor and Welfare (Japan). The CTD is maintained by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The agreement to assemble all the quality, safety and efficacy information in a common format has revolutionized the regulatory review processes.

General Consideration
- CTD is -
* Only a harmonized format for submission of information to relevant regulatory
authorities.
* Template for presenting data in the dossier.
* A guideline that merely indicates an appropriate format for the data that have
been acquired.
- CTD is not -
* A statement of data for application of data.
* A guideline that intends to indicate what studies are required.
* Define the content.
- CTD should be -
*Have clear and unequivocal information.
*Have style & font size that is large enough to be easily readable.
*Follow the ICH guidelines for:
Document pagination and segregation.
Submission requirements/ methodology for CTD.
* Contained all abbreviation that are used & be listed at the end of the dossier.
* Give proper information of source of bulk drug(s) for manufacturing finished
formulation.

Regulation & regulatory bodies of CTD [5]
1) The regulation under Drugs and Cosmetics Act & Rules 122A, 122B and 122D and further Appendix I, IA and VI of Schedule Y, describe the information required for approval of an application to import or manufacture of new drug for marketing.
2) Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.
3)  Almost all the independent countries of the world have their own regulatory authorities.

Evolution of CTD [6]
Effort over the past 15- 20 years by ICH of technical requirements for "registration of pharmaceutical for human use" have resulted in a uni-field dossier for drug applications. CTD was officially signed off in November 2000, at 10th anniversary of ICH; San Diego, California.

Fig 1 : Evolution of CTD

The following are the examples of a few of them (Regulatory Authority):

Table 1 : List of countries and their Regulatory Authority (ICH-CTD)[4]

Country

Regulatory Authority

Australia

Therapeutic Goods Administration (TGA)

Argentina

National administration of  Drugs, Food & Medical Technology (ANMAT)

Armenia

Drug & medical Technology Centre, Ministry of Health

Austria

Federal ministry for Health

Brazil

National Agency for Sanitary Vigilancia (ANVISA)

Belgium

Federal public services( FPS) Health

Bolivia

Ministry of Health and Sports

Bulgaria

Bulgarian Drug Agency (BDA)

Canada

Health Canada

China

State Food and Drug Administration (SFDA)

Colombia

National Institute of Food and Drug monitoring( INVIMA)

Croatia

Ministry of Health and Social Welfare

Denmark

Danish Medicines Agency

Ecuador

Ministry of Public Health

Egypt

Ministry of Health & population

Estonia

State Agency of Medicines

Europe

European Medicines Agency (EMEA)

Fiji

Ministry of Health

Finland

Finnish Medicines Agency

France

French Agency for Sanitary Safety of Health Products, ministry of Health

Germany

Federal Institute for Drugs and  Medical Devices

Georgia

Ministry of Labor, Health and Social Affairs of Georgia

Greece

National Organization for Medicines (EOF)

Guam

Department of Public Health and Social Services

Hong Kong

Department of Health: Pharmaceutical Services

Hungary

National Institute for Pharmacy

Iceland

Icelandic Medicines Agency

India

Central Drug Standard Control Organization (CDSCO)

Ireland

Irish Medicines Board

Italy

Italian Pharmaceutical Agency

Jamaica

Ministry of Health

Japan

Ministry of Health, Labour & Welfare(MHLW)

Jordan

Ministry of Health

Kenya

Ministry of Health

Latvia

State agency of medicines

Lithuania

State Medicines Control Agency

Maldives

Ministry of Health and Family

Malaysia

National Pharmaceutical Control Bureau, Ministry of Health

Mauritius

Ministry of Health and Quality of Life

Namibia

Ministry of Health and Social Services

Nepal

Ministry of Health and Population

New Zealand

Medicines and Medical Devices Safety Authority (MEDSAFE)

Nigeria

National Agency for Food and Drug Administration and Control (NAFDAC)

Norway

Norwegian Medicines agency

Panama

Ministry of Health

Paraguay

Department of Health: Pharmaceutical Services

Poland

Ministry of Health & Social Welfare

Portugal

The National Institute of Pharmacy and Medicines

Romania

National Medicines Agency (ANM)

Russia

Ministry of Health and Social Development

Senegal

Ministry of Health & Prevention

Serbia

Medicines and Medical devices Agency (ALIMS)

Singapore

Center for Pharmaceutical Administration Health Sciences Authority

South Korea

Food and Drug Administration

South Africa

Medicines Control Council (MCC)

Spain

Medicines and Health Product Agency (AEMPS)

Switzerland

Swiss Agency for Therapeutic Products (SWISSMEDIC)

Taiwan

Department of Health

Tanzania

Ministry of Health and Social Welfare

Thailand

Ministry of Public Health

UK

Medicines and Healthcare Products Regulatory Agency (MHRA)

USA

Food and Drug Administration (FDA)

Uruguay

Ministry of Public Health

Venezuela

Ministry of Public Health

Vietnam

Ministry of Health

Yemen

Ministry of Public Health and Population

Zimbabwe

Medicine Control Authority of Zimbabwe (MCAZ)

INTERNATIONAL ORGANIZATIONS [7-10]
Some of the international regulatory agencies and organizations which also play essential role in all aspects of pharmaceutical regulation related to drug product registration, manufacturing, distribution, price control, marketing, research and development and intellectual property protection.

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