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Role of Regulatory Affairs in the Production of Pharmaceutical Products in All

over the World

Article in International Journal of Pharmacy and Biological Sciences · May 2023

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 Human Journals
Short Communications
July 2020 Vol.:18, Issue:4
© All rights are reserved by Afshan Siddiq et al.

Role of Regulatory Affairs in the Production of Pharmaceutical

Products in All over the World
Keywords: Regulatory Affairs (RA), Negotiation,
Implementation and Commercial

ABSTRACT
Afshan Siddiq1*, Riaz urrehman2, Haseeb-ur-
INTRODUCTION: Regulatory affairs has been a very
Rehman1, Duaa Fatima1, Sidra Tul Muntaha1
important department in the pharmaceutical Company during
1
Department of Pharmacology, Faculty of Pharmacy the last few years. Currently, this department helps safeguard

and Pharmaceutical Sciences, University of Karachi, the products' life cycle and guide the company on regional and

Karachi, Pakistan global laws/regulations set forth by different regulatory

authorities. ROLE: Regulatory affairs (RA) professionals play
2
Directorate of Medical Sciences, GC University critical roles. People who work in regulatory affairs negotiate
Faisalabad the interaction between the regulators, the regulated and the
market to get high standard products to the market and to keep
Submission: 23 June 2020
them there preventing substandard products from being
Accepted: 29 June 2020
marketed. They give strategic and technical advice at the
Published: 30 July 2020
highest level in their companies, from the beginning of the
development of a product, making a major contribution both
commercially and scientifically to the success of a company as
a whole. In today's competitive environment the reduction of
the time taken to reach the market is critical to the company’s
www.ijppr.humanjournals.com
success. CONCLUSION: The proper implementation of
regulatory guidelines and laws will improve the economic
growth of the industry and also improve the safety of the
people.
 www.ijppr.humanjournals.com

INTRODUCTION:

All companies, whether they are multinational pharmaceutical corporations or small,

innovative biotechnology companies, have specialist departments of regulatory Affairs. The
success of a regulatory strategy is less dependent on the regulations than on how they are
interpreted and connected within companies and to outside constituents. Regulatory affairs
have been the very prime department in pharmaceutical Companies during the last few years
in Asia and other countries. Currently, this department helps to guard the product life cycle
and lead the company on regional and global laws/regulations set forth by different
regulatory authorities. Principally, this consists of data proving that the drug has quality,
efficacy and safety properties suitable for the intended use, additional administrative
documents, samples of the finished product, and reagents necessary to perform analyses of
the product. Therefore, they are the vehicle in a country through which drug sponsors
formally propose that the regulatory agencies approve a new pharmaceutical for sale and
marketing.

HISTORICAL OVERVIEW OF REGULATORY AFFAIRS:

During the 1950s, multiple tragedies i.e. sulphanilamide elixir, vaccine tragedy, and
thalidomide tragedy have resulted in a substantial increase of legislation for drug product
quality, safety, and efficacy. This has also resulted in stricter norms for Marketing
Authorization (MA) and Good Manufacturing Practices (GMPs).

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ROLE OF REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY:

Regulatory Affairs (RA) professionals concerned with the healthcare product lifecycle, it
provides strategic, and operational direction and support for working within regulations to
expedite the development and delivery of safe and effective healthcare products to
individuals all over the world. The role of regulatory affairs is to develop and execute a
regulatory strategy to ensure that the collective efforts of the drug development team result in
a product that is approval by global regulators but is also differentiated from the competition
in some way and also to ensure that the company’s activities, from non-clinical research
through to advertising and promotion, are conducted following the regulations and guidelines
established by regulatory authorities. Regulatory Affairs (RA) professionals play critical roles.
People who work in regulatory affairs negotiate the interaction between the regulators, the
regulated and the market to get high standard products to the market and to keep them there
preventing substandard products from being marketed. They give strategic and technical
advice at the highest level in their companies, from the beginning of the development of a
product, making a major contribution both commercially and scientifically to the success of a
company as a whole. In today’s competitive environment the reduction of the time taken to
reach the market is critical to the company’s success.

SCOPE OF REGULATORY AFFAIRS PROFESSIONAL IN INDUSTRIES:

 Regulatory affairs professionals are employed in industry, government regulatory

authorities, and academics.

 Wide range of regulatory professionals includes in these areas: Pharmaceuticals, Medical

Devices, In vitro diagnostics, Biologics, biotechnology, Nutritional Products, and Cosmetics.

DMF (Drug Master File)

Drug Master File is a submission to the Food and Drug Administration (FDA) that may be
used to provide confidential detailed information about facilities, processes, manufacturing,
processing, packaging, and storing of one or more human drugs. The information in the DMF
used to support the following,

– Investigational New Drug Application (IND),

– New Drug Application (NDA),

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– Abbreviated New Drug Application (ANDA),

– Export Application

TYPES OF DMFs:

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel.

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in drug
preparations, or Drug Product

Type III: Packaging Material.

Type IV: Excipient, Colorant, Flavor, or Essence

Type V: FDA Accepted Reference Information

DOSSIER: A document containing detailed records on a particular person or subject. Any

preparation of pharmaceutical product for human use experience the process of reviewing and
assessing the dossier of a pharmaceutical product which contains detailed information about
administrative, quality, non-clinical and clinical data and the permission permit by the
regulatory agencies of a country intending to support its marketing is called as" the
Marketing approval" or" registration Marketing authorization” or “Product Licensing”. This
process is governed by the Drug Regulatory Authority of a particular country and process is
called NDA in the USA, MAA in EU and other countries as simply registration Dossier.
There are two formats for dossier preparation i.e. ICH-CTD and ACTD. ICH-CTD followed
by ICH countries as well as developing countries whereas ACTD is followed by ASEAN
countries. ACTD act as a bridge between the regulatory requirements of developed and
developing countries. Also, if both guidelines of CTD and ACTD can be harmonized then the
variation between both guidelines can be minimized.

Evolution of CTD: Effort over the past 2 decades by ICH of technical requirements for
"registration of pharmaceutical for human use" have an outcome in a uni-field dossier for
drug applications.

COMMON TECHNICAL DOCUMENT (CTD): CTD is a set of identification for

application dossier for the registration of Medicines and designed to be used across Europe,
Japan, and the United States. CTD was developed by the European Medicines Agency (EMA,

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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 for Registration of Pharmaceuticals for Human Use. The agreement to
assemble all the quality, safety, and efficacy information in a common format have
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 the application of data.

 A guideline that intends to indicate what studies are required.

 Define the content.

 CTD should have clear and unequivocal information.

 Have a style & font size that is large enough to be effortlessly readable.

Follow the ICH guidelines for:

 Document pagination and segregation.

 Submission requirements for CTD.

 Contained all abbreviations that are used & be listed at the end of the dossier.

 Give proper information about the source of the bulk drug(s) for manufacturing finished
formulation.

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CTD MODULES:

•The documents, either for a marketing application, an investigational application, or a

related submission, should be organized based on the following five modules.

• Module 1 have administrative information and prescribing information.

• Module 2 have CTD summary documents.

• Module 3 have information on quality.

• Module 4 have the nonclinical study reports.

• Module 5 have a clinical study.

Regulation & regulatory bodies of CTD

1. The regulation under Drugs and marketing.

2. Every country has its regulatory authority, which 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 a new drug for.

3. Is responsible to enforce the rules and regulations and issue guidelines for drug
development, licensing, manufacturing, marketing, and labeling of pharmaceutical products.

4. More or less all the independent countries of the world have their regulatory authorities.

ORGANIZATION OF ASEAN CTD (ACTD) FORMAT:

ACTD is a guideline for the preparation of well-structured CTD applications that would be
submitted to ASEAN regulatory authorities for the registration of pharmaceuticals products.
Four parts of ACTD are:

- Part I: Table of Contents, Administrative Data, and Product Information

- Part II: Quality Document

- Part III: Nonclinical Document

- Part IV: Clinical Document.

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Regulatory Environment in Different Countries:

The regulatory environment in different countries of the world is different according to their
rules and regulation of regulatory bodies.

Table No. 1: List of countries and their Regulatory Authority (ICH-CTD)

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
Canada Health Canada
China State Food and Drug Administration (SFDA)
Colombia National Institute of Food and Drug Monitoring (INVIMA)
Denmark Danish Medicines Agency
Egypt Ministry of Health & population
Europe European Medicines Agency (EMEA)
Fiji Ministry of Health
France French Agency for Sanitary Safety of Health Products, Ministry of Health

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Germany Federal Institute for Drugs and Medical Devices

India Central Drug Standard Control Organization (CDSCO)
Pakistan Drug regulatory authority in Pakistan
Italy Italian Pharmaceutical Agency
Japan Ministry of Health, Labour & Welfare (MHLW)
Malaysia National Pharmaceutical Control Bureau, Ministry of Health
Russia Ministry of Health and Social Development
Greece National Organization for Medicines (EOF)
Hong Kong Department of Health: Pharmaceutical Services
Hungary National Institute for Pharmacy
Ireland Irish Medicines Board
Maldives Ministry of Health and Family
Mauritius Ministry of Health and Quality of Life
Nigeria National Agency for Food and Drug Administration and Control (NAFDAC)
Romania National Medicines Agency (ANM)
Singapore Center for Pharmaceutical Administration Health Sciences Authority
Spain Medicines and Health Product Agency (AEMPS)
Zimbabwe Medicine Control Authority of Zimbabwe (MCAZ)
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Thailand Ministry of Health and Social Welfare
South Africa Medicines Control Council (MCC)
Switzerland Swiss Agency for Therapeutic Products (SWISSMEDIC)
Jordan Ministry of Health
South Korea Food and Drug Administration
Taiwan Department of Health
Nepal Ministry of Health and Population
Kenya Ministry of Health
New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)
Norway Norwegian Medicines agency
Indonesia National Agency of Drug & Food Control

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CONCLUSION:

This study shows that regulatory affairs is very important for all pharmaceutical companies
around the world. The main focus of the regulatory affairs department is to give safe and
effective medicine to people around the world. In this study, we show the responsibility of
regulatory affairs professionals. Drug regulatory agencies of various countries give the rules
which must be followed by pharmaceutical companies. A regulatory affair is also important
for research and development, product management, Clinical trial, and marketing
authorization. All pharmaceutical companies have their regulatory affairs department.
Regulatory Affairs is also a good profession for Post Graduate in Pharmacy with
pharmaceutical Administration and Management or Regulatory Affairs specialization will be
the preferred qualification to qualify for as a RA professional. To become a good regulatory
affairs officer executive, some special skills are needed like sound knowledge about
regulatory affairs and drug laws, and good communication skills. Regulatory Affairs is an
intellectually stimulating and highly regarded profession within pharmaceutical companies.

REFERENCES:

1. Y. Sri Harsha, V. Sharmila Reddy, D. Mary, D Nagarjunareddy, M. V. Nagabhusanam, Brahmaiah

Bonthagarala, Role of Regulatory Affairs in a Pharmaceutical Industry International Journal of Pharmaceutical
Research and Bio-Science, ISSN: 2277-8713, volume 6(2): 170-177, 23/04/2017,
2. S. M. Shakeel, Shaik Salman Basha, M.V. Nagabhusanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala,
comparison of regulatory 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.
3. Sharmila Reddy V, Mounica N.V.N., Anusha S, Evangeline L, Nagabhushanam M.V., Nagarjunareddy D,
Brahmaiah B, Regulatory Requirements of Similar Biologics for Marketing Authorization in India, ISSN: 2321
– 6794, DOI: https://doi.org/10.22270/ijdra.v5i1.193, International Journal of Drug Regulatory Affairs; 2017,
5(1), 20-24
4. Nighat Razvi, Muneeb Ahmed, Fakhsheena Anjum, Perspective of pharmaceutical regulatory affairs
professionals in Pakistan, Journal of Pharmaceutical and Biological Sciences, ISSN: 2320-1924, Volume 3(2):
51-55, 28-06-2015
5. The ASEAN announces moves to harmonize drug registration procedures
http://www.thepharmaletter.com/file/10875/the-aseanannouncesmoves-to-harmonize-drug-registration-
procedures.html
6. European Commission: The notice to applicants; Procedures for marketing authorization-2005: 2A
http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a chap1 2005-11 en (accessed on 21-May-2010)
7. Shrikant Godiyal, Regulatory requirements for preparation of Dossier for registration of Pharmaceutical
products in ACTD & CTD format, International Journal of Drug Regulatory Affairs. 2019; 7(2):51-61
8. ICH M4S Guideline: Nonclinical Overview and Nonclinical Summaries of Module 2 and Module 4: Safety
(R2) [Internet]. ICH; 2002 Dec [cited 2019 Mar 26]. Available from:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf
9. U.S. Department of Health and Human Services Food and Drug Administration, ICH; 2017 Oct.

Citation: Afshan Siddiq et al. Ijppr.Human, 2020; Vol. 18 (4): 469-478.

477
 www.ijppr.humanjournals.com

10. Jordan D. An overview of the Common Technical Document (CTD) regulatory dossier, The European
Medical Writers Association, VOL.23 NO.2; 2014
11. ASEAN Common Technical Dossier (ACTD) Jakarta, ASEAN Secretariat; 2016 Dec
12. Rahul Kr Raj, Pritosh Pattanaik, Harekrishna Roy, The Dynamics of Global Pharma Regulatory Affairs
System Indo American Journal of Pharmacy, Volume 1 (1), 2015, Page-28-34
13. Pharmaceutical Regulatory Affairs: Open Access, “Historical Overview of Pharmaceutical Industry and
Drug Regulatory Affair”, HasumatiRahalkar, Kurz, PharmaceutReg Affairs 2012, S11-002
14. Introduction to Generic Drug. Published in WHO [Internet]. WHO; 2015 [cited 2014Dec10]? Available
from: http://www.who.int/trade/glossary/story034/en.
15. http://www.ordonearresearchlibrary.com/data/pdfs/ ajpsr2.pdf
16. Bhardwaj S. et al. Comparative study: requirements for the submission of Generic drug application across
US and EU in CTD/eCTD format. AJPSR. [Internet] 2011 [Cited on 2014Dec 15]; 1(5):1-14. Available from:
http://www.ordonearresearchlibrary.com/Data/pdfs /AJPSR22.pdf.
17. http://www.fda.gov/AboutFDA/WhatWeDo/Histor y/Milestones/default.htm
18. Badjatya J, and Bodla R. “Harmonization & advancement in pharmaceutical industry”. International
Journal of Drug Regulatory Affairs, Vol. 1, no. 2, Feb. 2018, pp. 7-10, doi: https://doi.org/10.22270/ijdra.v1i2.4.
19. ICH. The Common Technical Document [Internet]. ICH; 2019 [cited 2019 Mar 26]. Available from:
https://www.ich.org/products/ctd.html
20. Drug Act 1976 http://medisure.com.pk/druglaw/DrugAct+Rules/index.htm
21. The new drug development process: The CDER Handbook http://www.fda.gov/downloads/About
FDA/Centre Offices/CDER/UCM198415.pdf (accessed on 6-Mar-2011)
22. World Health Organization. Ethical criteria for medical drug promotion. Available:
http://www.who.int/medicinedocs. Accessed Aug 3, 2008.

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