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ABBREVIATIONS IN THE PHARMACEUTICAL

INDUSTRY: KEY TERMS IN DRUG DEVELOPMENT
AND REGULATION

2023

The pharmaceutical industry worldwide uses many abbreviations when

communicating with each other and the regulatory bodies. Several of these linked to
drug development and medicine registration are listed below.

 ICH
 MHRA
 CTD
 QA
ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals

for Human Use):

Description: ICH is an international nonprofit organization that brings pharmaceutical industry and

medicine regulatory authorities together to harmonize scientific and technical aspects of medicinal

product development and registration process. The aim of the ICH is to improve public health, prevent

duplication of clinical trials in humans, and decrease the use of laboratory animals by ensuring

international harmonization through the development of standard requirements and protocols for

pharmaceutical product registration (1). Harmonization is accomplished through the development of ICH

guidelines via a process of scientific consensus with experts from regulatory authorities and industry. The

benefits of international harmonization include greater efficiency in the regulatory review process,

minimal time to bring a product on the market, decreased chances of duplication of clinical trials,

reduction of animal use in drug development phases, and the availability of quality medicines to the

public (2).

In 1980s, the European Union (EU), the United States (US), and Japan initiated efforts for a global

harmonization. Ultimately, ICH was created in 1990 with an initial objective of establishing coordination

among regulatory bodies of these countries in consultation with the pharmaceutical trade organizations,

to discuss the scientific issues arising during the process of product registration (3). Since then, the ICH

has directed its activities to more global benefits beyond the founding ICH regions. The development of

harmonized guidelines and their implementation is achieved in five steps (4):

1. Preparing consensus draft

2. Confirmation of consensus on the technical document

3. Regulatory consultation and discussion

4. Adoption of guideline

5. Implementation
MHRA (Medicines and Healthcare products Regulatory Agency):

Description: The MHRA, established in 2003, is a national executive body of the government of the

United Kingdom (UK) which regulates the safe and appropriate utilization of medicines and medical

devices and blood components for transfusion (5). The primary mission of MHRA is to ensure that such

products meet robust standards of safety and efficacy for use by patients and the general public (6).

Key responsibilities of MHRA (7, 8):

1. Regulatory approval: The agency is mandated to assess and authorize the sale and supply of

medicines, vaccines, and medical devices in the UK.

2. Post-marketing surveillance: MHRA uses the Yellow Card Scheme for monitoring and reporting of

adverse drug events of medicines once they are on the market.

3. Clinical Trials Regulation: It regulates and oversees clinical trials of medicines and medical

devices to ensure that they meet ethical and safety standards.

4. Safe Use of Medicines: The agency promotes the safe and effective utilization of medicines and

medical devices by supplying authentic information to healthcare providers, patients, and the

general public.

5. Inspection and Enforcement: MHRA carries out inspections of pharmaceutical product

manufacturers and enforces adherence to statutory obligations through warnings and

prosecutions where necessary.

The MHRA plays an important role in protecting public health by ensuring that medicinal products

and medical devices meet statutory requirements of quality, safety, and efficacy. It coordinates with

regulatory agencies and organizations from other countries to make sure that international standards

align with UK’s regulatory guidelines.

 CTD (Common Technical Document):

Description: The CTD is an internationally agreed standard set of specifications for organizing and

submitting regulatory information and data for the registration of drugs, biologics, and medical

devices. The document contains key information about administrative information, data on safety,

efficacy, and quality of the medicinal product. The CTD is designed to be used across Europe, the

USA, and Japan and beyond (9). This format was developed by the ICH and is required by regulatory

bodies such as the Food and Drug Administration (FDA) in the USA, the European Medicine Agency

(EMA) in the EU, and the Ministry of Health, Labor, and Welfare (Japan) for the approval and

registration of new drugs (9). The CTD format has been adopted by several other nations including

Canada and Switzerland.

The CTD consists of the following five modules (10):

1. Administrative and Prescribing Information: This module comprises of administrative and legal

details about the submission, containing a cover letter and the application form.

2. Overviews and Summaries of Modules 3-5: This module contains a general introduction to the

medicinal product, including the pharmacological category, mechanism of action, and proposed

therapeutic use. Module 2 also provides an overall summary of information on quality, as well as

the clinical and the non-clinical overview.

3. Quality: Module 3 contains the composition, manufacturing, and controls reports for the

medicinal product.

4. Non-clinical Study Reports: It contains data from non-clinical studies (animal data) such as

pharmacokinetics, pharmacology and toxicology.

5. Clinical Study Reports: This module includes data from clinical trials, including reports of human

safety, efficacy, pharmacokinetics and pharmacodynamics studies.

Figure 1 illustrates the CTD modules.

 Fig 1: The CTD triangle. Adapted from Wikipedia (reusable image)

QA (Quality Assurance):

Description: The term quality assurance in the pharmaceutical industry is used to describe the systematic

efforts and set of activities taken to assure that medicinal products are developed, manufactured, tested,

and released consistently with the required quality standards and in compliance with the regulatory

requirements (11, 12). The purpose of quality assurance in the pharmaceutical sector is to make sure

that each drug and medical product reaching a patient is effective, safe, and of standard quality.

Key elements of quality assurance:

1. Ensuring Compliance with Regulations: Manufacturing plants must comply with local and

international guidelines and regulations such as those set by the FDA and EMA. QA departments

establish and maintain systems that ensure adherence to these regulations.

2. Implementing Good Manufacturing Practices (GMPs): GMPs are a set of recommendations that

define the minimum standards for the production, testing, and quality assurance of

pharmaceutical manufacturing. Pharmaceutical companies must adhere to GMP guidelines.

 3. Documentation: Comprehensive documentation and record-keeping of all aspects of

pharmaceutical life cycle are very important in quality assurance. This includes the

documentation of research and development, manufacturing, and distribution.

4. Continuous Improvement and Risk Management: It is crucial to identify and minimize potential

risks in the manufacturing process to eliminate problems that could compromise product quality.

Relationship between the Terms

To summarize, these abbreviations are all interconnected in the pharmaceutical products development

and manufacturing. ICH supplies international standards and guidelines for product development to be

adopted by regulatory organizations such as FDA and MHRA. The CTD is used to present data to these

regulatory bodies, guaranteeing uniformity and efficiency in the application process. QA strengthens the

overall process, ensuring that drugs and medical products meet the standards of safety and quality in line

with the guidelines set forth by ICH and the MHRA.

References

1. Mullin T. International regulation of drugs and biological products. Principles and

Practice of Clinical Research: Elsevier; 2018. p. 87-98.
2. Junod V. Clinical drug trials: studying the safety and efficacy of new pharmaceuticals:
Schulthess; 2005.
3. Teasdale A, Elder D, Nims RW. ICH quality guidelines: An implementation guide: John
Wiley & Sons; 2017.
4. Van der Laan JW, DeGeorge JJ. Global approach in safety testing: ICH guidelines
explained: Springer; 2013.
5. Evans SJ, Day SJ. M edicines and H ealthcare P roducts R egulatory A gency
(MHRA)(Formerly MCA). Encyclopedia of Biostatistics. 2005;5.
6. Demasi M. From FDA to MHRA: are drug regulators for hire? bmj. 2022;377.
7. Khin NA, Francis G, Mulinde J, Grandinetti C, Skeete R, Yu B, et al. Data integrity in
global clinical trials: discussions from joint US food and drug administration and UK medicines
and healthcare products regulatory agency good clinical practice workshop. Clinical
Pharmacology & Therapeutics. 2020;108(5):949-63.
8. Seabroke S, Wise L, Waller P. Development of a novel regulatory pharmacovigilance
prioritisation system: an evaluation of its performance at the UK medicines and healthcare
products regulatory agency. Drug safety. 2013;36:1025-32.
9. Junod V. Clinical drug trials. Studying the safety and efficacy of new pharmaceuticals
Genève, Zurich, Bâle, Genève, Bruxelles: Schulthess. 2005.
10. Jordan D. An overview of the Common Technical Document (CTD) regulatory dossier.
Medical Writing. 2014;23(2):101-5.
11. Waasiullah M, Yadav P, Yadav S, Singh P. QUALITY CONTROL AND QUALITY
ASSURANCE IN PHARMACEUTICALS INDUSTRY. 2022.
12. Immel B. Quality Assurance of Pharmaceuticals. Encyclopedia of Pharmaceutical Science
and Technology, Six Volume Set (Print): CRC Press; 2013. p. 2885-94.