IMPORTANCE OF

REGULATORY AFFAIRS IN
PHARMACEUTICAL INDUSTRY
OF BANGLADESH
By Sumaya Islam, 1520811646

Submitted to: Dr. Manik Chandra Shill

PHR323, Section 1
 What is Regulatory Affairs?

In the fields such as drugs, veterinary medicinal products, medical equipment, pesticides,
agrochemicals, cosmetics, and complementary medicines, regulatory affairs is the profession that
has been established out of government desire to protect public health, controlling product safety
and effectiveness and the discovery, testing, manufacture and marketing of these products. A
new class of professionals has emerged to deal with these company regulatory matters.

Regulator of pharmaceutical affairs has a vital role to play in introducing new regulations to
research and production of new medicines to avoid it creating specific laws in pharmaceutical
product manufacturing.

Regulation includes thorough assessment of a potential drug product to ensure public health
safety, product promotion, registration of products, authorization to market, import and
distribution, pharmacovigilance. Regulatory Affairs is a fairly new discipline that has emerged
from the government's desire to protect public health by regulating drug safety and effectiveness
in areas like pharmaceuticals, veterinary medicines , medical equipment, pesticides,
agrochemicals, cosmetics and complementary medicines.

Regulatory relations is a complex combination of research and management to accomplish a

target that is of strategic significance within a drug manufacturing organization. Regulatory
affairs is responsible for the management of business plan, monitoring / writing / review and
assembly and submission. They offer strategic and technological guidance at the highest level of
their companies’ right from the beginning of product growth, making a significant contribution
to the success of a production plan and the enterprise as a whole, both commercially and
scientifically.

Regulatory relations in pharmaceutics are like inspectors of cars in the automotive industry. Our
access and conduct quality checks to ensure that the veterinary prescription drugs and dietary
supplements rolled out by the pharmaceutical industry are safe and efficient for use by the
clients. In other words, regulatory affairs are in place to protect public health by evaluating the
production and promotion of pharmaceutical products of the drug Discovery coma processes.
 Why is Regulatory Affairs Important?

In today's competitive world, reducing the time taken to enter the market is essential to the
success of a product and thus of the business. Therefore the proper conduct of its regulatory
affairs activities is of great economic importance to the company.

Insufficient data collection can prevent a timely successful evaluation of a marketing application.
The production of a new drug could have cost millions of pounds, euros or dollars, and even a
three-month delay in getting it to the market has significant financial implications. Much worse,
failure to properly disclose all available data or release of incorrect labeling of the drug bearing
can quickly lead to a product recall need.

A good professional in regulatory affairs should have a 'right first' mindset and will play a very
important role in integrating research activities with regulatory requirements during the product’s
existence, helping optimize the cost-effective use of the company's resources. The Department of
Regulatory Affairs is most frequently the first point of contact between regulatory authorities and
the company. For a organization whose members are scientifically reliable and competent,
officials respond far better than to one in which those attributes are absent.

Drug production is tightly regulated for commercialization. Each medication must undergo
stringent testing and clinical trials to ensure its health, effectiveness and efficiency before it gets
market approval. Such standards are defined by regulatory authorities of their respective
countries, such as the US FDA and Bangladesh DCA etc. Regulation affects all aspects of the
pharmaceutical world as well as regulatory and administrative bodies and patients, from
independent innovators and pharmaceutical companies. Regulatory department is a critical link
between businesses, goods and regulatory authorities whose positive or negative perspective
fosters the regulatory authority's insight into the market, for better or for worse. Therefore, the
better the scientific precision, the greater the chances of a product coming onto the market within
the time expected.

Function of Regulation and Regulatory Affairs

Regulatory relations in the pharmaceutical industry provide a number of roles for stopping one of
these activities, including keeping up-to - date with improvements in our manufacturing and
marketing laws on pharmaceutical track research. This is a critical task, as keeping updated the
pharmaceutical industry's rules and regulations will coffin the pharmaceutical companies'
manufacturing and marketing practices.

Additionally, regulatory issues are deeply involved in gathering populating form and compiling
scientific data for evaluation in search of quality discrepancies or compromises. It is done by
collecting the various registration records that are grouped into parts called Common Technical
Records, and consolidating them to create a demand for a common dose and intensity for and
pharmaceutical product.

The regulatory aspect is arguably the most important element of the job as it decides whether the
pharmaceutical product can ever be released on the market to avoid the selection, processing and
compilation of substances such as scientific evidence and medical problems arising from clinical
trials and experimental tests on the pharmaceutical drug. Regulatory agencies must apply the
combined request of regulatory affairs practitioners for review as if they are the administration of
food and drugs before authorization can be given for the manufacturer, marketing and selling of
the pharmaceutical product. Regulatory issues are therefore important in shielding the
pharmaceutical industry from any neck chains risks or overnight interference by ensuring that the
firm maintains careful documentation of clinical results, research evidence and reliable input
monitoring on the efficacy and side effects of the tasted products.

Therefore, it is very clear that regulatory matters are important to indicate the direction of drug
production and product launches in the Mammoth Industry pharmaceutical sector, and that its
function is vital to the scientific and commercial success of a pharmaceutical product, right from
the conception of the idea at the research and development stage, throughout the process of the
clinical area.

Furthermore, regulatory affairs extend its influence to coordinating with various other regulatory
agencies and departments to facilitate the submission of adequate and accurate information for
evaluation to ensure that the pharmaceutical products penetrate and perform it on the market
quickly as a successful approval. Regulatory matters are also the language spoken by the
international drug regulatory community and, as such, the language from the contact between
teams and multidisciplinary individuals to the passage date of the pharmaceutical goods life
cycle.
It is a well-known fact that the production of innovative medicines and drugs has played a crucial
role in healthcare services and delivery which has made the entire healthcare industry expand at
an growing rate. While Bangladesh's pharmaceutical industry is emerging as one of the fast-
growing markets on a global scale, its export market is also expanding worldwide. As a result,
proper medicinal regulations need to be in place to ensure the drugs' quality, safety, and
effectiveness. Even the smallest of the mistakes will ultimately recall the product, leaving the
company several million at loss.

In deciding the chances of drug production and the product to reach the market, the regulatory
department maintains a vital link between drug manufacturers, businesses and regulatory
authorities. Regulation requires a specific and thorough evaluation of a particular medication to
ensure that the substance is covered by public health, medication licensing, marketing
authorization, pharmacovigilance, import, export, and distribution. Regulatory Affairs is a
combination of research and management that helps the drug-development organizations achieve
their commercial target. Regulatory Affairs is responsible for all relating to the implementation
plan to monitor / review the criteria for submission in the product production and authorization
phase

The Responsibilities of the Regulatory Affairs Professionals

The Regulatory Affairs Department is established to protect public health by monitoring and
controlling drug safety and efficacy across multiple domains, including pharmaceuticals,
veterinary medicines, agrochemicals, cosmetics, medical devices, pesticides, and complementary
drugs. Regulatory Affairs' primary role is to provide the pharmaceutical companies with strategic
and technical advice, from drug development to the successful product marketing.

This is the duty of the Regulatory Affairs to keep the businesses aware of existing policy
regulations, rules, regulatory information and consumer experience. This also guarantees that the
medications and goods of the organization comply with current laws and that the entire product
portfolio is kept up-to - date with the evolving regulatory practices. We also advise about the
legal and technical constraints, limitations, and specifications for the product, and help
businesses compile, collate, and review the R&D department's scientific knowledge.
Regulatory affairs professionals also have an essential role to play in formulating regulatory
strategies for companies to submit suitable regulatory documents for international, domestic
and/or contract projects. The RA advises them on international legislation and guidelines for
export and import. We help high-level corporate executives plan, prepare and review all
documents and submissions submitted to regulatory authorities, ensuring we are transparent,
reliable and thorough from a regulatory perspective.

A proper conduct of regulatory affairs activities is vital to the survival of the company and the
quality of its goods in today's competitive climate. The regulatory concerns in the pharmaceutical
industry provide physicians and other healthcare professionals with detailed and reliable
information about the drug / product’s efficacy, safety, and effectiveness.

Future of Regulatory Affairs in Bangladesh

It is a well-known fact that the production of innovative medicines and drugs has played a crucial
role in healthcare services and delivery which has made the entire healthcare industry expand at
an growing rate. While Bangladesh's pharmaceutical industry is emerging as one of the fast-
growing markets on a global scale, its export market is also expanding worldwide. As a result,
proper medicinal regulations need to be in place to ensure the drugs' quality, safety, and
effectiveness. Even the smallest of the mistakes will ultimately recall the product, leaving the
company several million at loss. For this reason, regulatory affairs in the pharmaceutical industry
have a crucial role to play in compliance with the norms, regulations and guidelines in all phases
of drug development, drug approval and marketing.

The organized and structured Bangladesh pharmaceutical industry is attracting foreign

companies to the Bangladesh market for its feasibility of increasing operations. To cope with that
market, maintaining a well-tuned drug regulatory structure and regulatory regulations has
become a requirement for the regulatory affairs.

References

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Bonthagarala, Brahmaiah & Harsha, Y. & Reddy, V.Sharmila & Mary, D. & D.Nagarjunareddy, &
Nagabhusanam, M.. (2017). Role of regulatory affairs in a pharmaceutical industry.
International journal of pharmaceutical research and bio-science. 6. 170-177

Swain, S. (2016). Responsibility of Regulatory Affairs in Pharmaceutical Industry. Pharmaceutical

Regulatory Affairs: Open Access, 01(01). doi: 10.4172/2167-7689.1000e104

Choudhary, A. (2020). Role of Regulatory Affairs in Pharmaceuticals. Retrieved 27 August 2020, from
https://www.pharmaguideline.com/2019/06/role-of-regulatory-affairs.html

Regulatory Affairs: an Overview | PharmaTutor. (2020). Retrieved 27 August 2020, from

https://www.pharmatutor.org/articles/an-overview-of-regulatory-affairs-and-its-importance-in-
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