Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

1. Presented By
Mrs. Rama Shukla
Department of Pharmaceutics
Lakshmi NarainCollege of Pharmacy
M.P. Bhopal

2. Learning Objectives:
After completion of reading this Topic, you should have basic understanding:
•What is regulatory affairs and why it is important in pharmaceutical
industries?
•Roles and responsibilities of regulatory professionals.
•Regulatory authorities functions and access to list of global regulatory
authorities and organization with their website links.
•What is ICH and list of ICH guidelines?
•Career of Regulatory affairs.

3. The Regulatory Affairs (RA) within the pharmaceutical and
biotechnology industries called Pharma Regulatory Affairs or Drug
Regulatory Affairs.
 Most companies such as MNC companies, small scale industries, and
medium sized companies have these RA specialist departments.
The Regulatory Affairs in a Pharmaceutical industry, is a profession
which acts as the interface or liaison between the pharmaceutical industry
and Drug Regulatory authorities across the world.
 They are mainly involved in the registration of the drug products in
different countries prior to their marketing across the globe.

4. • Authorization for journey of product from the Laboratory to Pharmacy
Shop (Discovery to market).
• Huge investments and high stake in commercialization of new
pharmaceutical product.
•“ Right First Time” approach is necessary as time taken for the product to
reach market is critical for success.
• Foremost points of contact between the company and regulatory demands
authorities.
• Co-ordination of the scientific endeavors with regulatory demands
throughout Life of the product.
• Helps company meet all regulations and guidelines thus maximize profits.

5. •Regulatory affairs in the pharmaceutical industry aim at the protection
of human health.
•People and government spent money on drugs because of the role
they can play in saving lives, restoring health, preventing diseases
and stopping epidemics. But, in order to do so, drugs must be safe,
effective and of good quality.
The main objectives are;
•Protection of human health
•Ensuring safety, efficacy and quality of drugs
•Ensuring appropriateness and accuracy of product information.

6. Major incidents made us understand that rules and regulations are
required to prove safety along with efficacy of drugs. Such incidences
are as follows:
• Diphtheria Epidemic led to 1902 Biologics Control Act
• Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act
• Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act
• Thalidomide led to the 1962 Kefauver-Harris Amendments
• Dalkon Shield led to the 1976 Medical Device Amendments
• Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act.

9. •Keep in touch with International legislation, guidelines and customer practices.
•Ensure that a company’s products comply with the current regulations.
•The Regulatory Affairs professional’s job is to keep track of the ever-changing
legislation in all the regions in which the company wishes to distribute its
products.
•Formulate regulatory strategy for all appropriate regulatory submissions for
domestic, international and/or contract projects.
•Coordinate, prepare and review all appropriate documents for example dossier
and submit them to regulatory authorities within a specified time frame in
conjugation with the organization.
•Prepare and review of SOPs related to RA. Review of BMR, MFR, change control
and other relevant documents.
•Monitor the progress of all registration submission.

10. • Maintain approved applications and the record of registration fees paid against
submission of DMF and other documents.
• Respond to queries as they arise, and ensure that registration/ approval is granted
without delay.
• Impart training to R&D, Pilot plant and RA. Team members on current regulatory
requirements.
• Advising their companies on the regulatory aspects and climate that would affect
proposed activities. i.e. describing the “regulatory climate” around issues such as the
promotion of prescription drugs and Sarbanes-Oxley compliance.
• Manage review audit reports and compliance, regulatory and customer inspections.
• Regulatory Affairs professionals help the company avoid problems caused by badly
kept records, inappropriate scientific thinking or poor presentation of data.

11. Regulatory authorities has a variety of functions:
• Guaranteeing the safety, efficacy and quality of drugs
• Licensing of premises, persons and practices
• Inspection of manufacturing facilities and distribution channels
• Product assessment and registration
• Adverse drug reaction monitoring
• Quality control
• Control of drug promotion and advertising
• Provides independent, science-based recommendations on the
quality, safety and efficacy of medicines Applies efficient and
transparent evaluation procedures to help bring new medicines to
the market.
• Scientific advice to stimulate the development and improve the
availability of innovative new medicines.

12. The major challenges of these regulatory authorities are:
• To promote public health and protect the public from harmful and dubious
(doubting) drugs.
• To establish proper legalization covering all products with a medicinal claim and
all relevant pharmaceutical activities, whether carried out by the public or the
private sector
• To increase worldwide regulatory growth to ensure the safety of people.

13. •ICH is an International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human use.
•ICH is collaborated with the regulatory agencies and pharma
industries to discuss and harmonize the scientific and
technical aspects for drug registration worldwide and make
sure that safe, effective and high quality of products are
developed and registered.
•ICH mission is to achieve greater harmonization worldwide to
ensure that safe, effective, and high quality medicines are
developed and registered in the most resource-efficient
manner.

14. ICH has developed four categories of guidelines as below:
•Quality Guidelines
•Safety Guidelines
•Efficacy Guidelines
•Multidisciplinary Guidelines.

15. • Q1A to Q1F Stability
• Q2 Analytical Validation
• Q3 A to Q3 D Impurities
• Q4 to Q4 B Pharmacopoeias
• Q5 A to Q5 E Quality of Biotechnological Products
• Q6 A and Q6 B Specifications
• Q7 Good Manufacturing Practice
• Q8 Pharmaceutical Development
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality System
• Q11 Development and Manufacture of Drug Substances
• Q12 Lifecycle Management
• Q13 Continuous Manufacturing of Drug Substances and Drug Products
• Q14 Analytical Procedure Development.

16. • S1A-S1C Carcinogenicity Studies
• S2 Genotoxicity Studies
• S3A-S3B Toxicokinetics and Pharmacokinetics
• S4 Toxicity Testing
• S5 Reproductive Toxicology
• S6 Biotechnological Products
• S7A-S7B Pharmacology Studies
• S8 Immunotoxicology Studies
• S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
• S10 Photosafety Evaluation
• S11 Non Clinical Paediatric Safety
• S12 Non Clinical Biodistribution Studies for Gene Therapy Products.

17. E1 Clinical Safety for Drugs used in Long-Term Treatment
E2A-E2F Pharmacovigilance
E3 Clinical Study Reports
E4 Dose-Response Studies
E5 Ethnic Factors
E6 Good Clinical Practice
E7 Clinical Trials in Geriatric Population
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group in Clinical Trials
E11-E11A Clinical Trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation of QT
E15 Definitions in Pharmacogenetics / Pharmacogenomics
E16 Qualification of Genomic Biomarkers
E17 Multi-Regional Clinical Trials
E18 Genomic Sampling
E19 Safety Data Collection
E20 Adaptive Clinical Trials

18. • M1 MedDRA Terminology
• M2 Electronic Standards
• M3 Nonclinical Safety Studies
• M4 Common Technical Document
• M5 Data Elements and Standards for Drug Dictionaries
• M6 Gene Therapy
• M7 Mutagenic Impurities
• M8 Electronic Common Technical Document (eCTD)
• M9 Biopharmaceutics Classification System-based Biowaivers
• M10 Bioanalytical Method Validation
• M11 Clinical Electronic Structured Harmonised Protocol
• M12 Drug Interaction Studies
• M13 Bioequivalence for Immediate-Release Solid Oral Dosage
Forms

19. Regulatory Affairs is a versatile profession that provides
employment opportunities in a variety of organisations and at
various levels. RA professionals can find employment in the
following sectors:
•Pharmaceutical, medical devices, cosmetics and biotechnology companies
•Government agencies
•Clinical and hospital setting
•Clinical Research Organizations involved in new drug/medical
device/technology development.

20. • A degree in sciences (biology, microbiology, pharmacy, biochemistry,
pharmacology etc.) is a mandatory requirement for getting into RA.
• For junior positions, an undergraduate or postgraduate degree in science
is the norm. However, more senior positions, especially within clinical
research, require a person to hold a doctorate degree.
• For greater success in this field, it is recommended that one starts his
career in a related field e.g. quality control, laboratory testing, quality
assurance, production, etc. This helps an individual get practical experience
in drug development and its related processes.
• Though there is no mandatory requirement to have a formal degree in
regulatory affairs, a few organisations have started offering master’s
courses in pharmaceutical regulatory affairs.

21. Working within the regulatory affairs department requires an equal
measure of subject knowledge and soft skills. An individual must possess
the following skills in order to be successful.
• Drug development life cycle knowledge
• Critical thinking and data analysis skills
• Good writing skills
• Excellent oral and written communication skills (most of the work involves
communicating with inter-department staff, clients and regulatory authorities).
• Organisational and project management skills (Work will be varied and time
bound. Hence an ability to juggle different tasks efficiently is essential)
• Negotiation skills
• Ability to keep up to date on current regulations
• Basic to advanced computer skills.

22. 1. https://www.pharmariim.com/basic-knowledge-of-pharma-regulatory-
affairs/#:~:text=The%20Regulatory%20affairs%20is%20developed,agrochem
icals%2C%20cosmetics%20and%20complementary%20medicines.