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Module 1 : What is Regulatory Affairs
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Module 1: What is Regulatory Affairs
It is a unique mix of science and management to achieve a
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commercially important goal within a drug development organization.
It includes everything relating to drugs from the earliest nonclinical
studies, through development, into routine manufacture and marketing,
can add significant impact for patients and drug companies.
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Regulatory Affairs (Department)
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Healthcare Industries
Pharmaceuticals, Medical Devices,
Biologics and Functional Foods
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Major multinational pharmaceutical
corporations or small, innovative
biotechnology companies
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Regulatory Affairs Department
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Historical Overview
During 1950s, multiple tragedies i.e. sulfanilamide elixir,
vaccine tragedy and thalidomide tragedy have resulted in
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substantial increase of legislations for drug products quality,
safety and efficacy.
This has also resulted into stricter norms for Marketing
Authorization (MA) and Good Manufacturing Practices
(GMPs).
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Historical Overview of Regulatory Affairs (Key regulatory events with year)
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All medicines must meet 3 criteria :
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Quality Efficacy
Safety
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Pharmaceutical Drug Regulatory Affairs (DRA)
is a dynamic field that includes following aspects
of drug development:
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Scientific
Legal
Commercial
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Drug development to commercialization is highly regulated.
Every drug before getting market approval must undergo
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rigorous scrutiny and clinical trials to ensure its safety, efficacy
and quality.
These standards are set by regulatory authorities of their
respective countries such as FDA in US and CDSCO in India
etc.
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Regulation of Drug products involve following areas –
Non-clinical and Clinical Drug Development Guidelines
Licensing (Patent)
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Drug Registration
Manufacturing
Quality and safety Guidance
Pricing and Trademark
Marketing, Import and Distribution of Drug products
Pharmacovigilance (Adverse Drug Reactions monitoring)
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Major regulatory agencies
World Health Organization (WHO),
United States Food and Drug Administration (USFDA, United States),
European Medicines Agency (EMA, European Union),
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Medicines and Healthcare Products Regulatory Agency (MHRA, UK),
Therapeutic Goods Administration (TGA, Australia),
Health Canada (Canada),
Pharmaceuticals and Medical Devices Agency (PMDA, Japan)
Agency Nacional degradation vigilancia sonotoria (ANVISA, Brazil)
Medicine control council (MCC, South Africa)
Central Drugs Standard Control Organization (CDSCO, India).
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IMPORTANCE OF REGULATORY AFFAIRS
In today's competitive environment the reduction of the
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time taken to reach the market is critical to a product's and
hence the company's success.
The proper conduct of its Regulatory Affairs activities is
therefore of considerable economic importance for the
company.
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Not unified across the
companies and is
Organizational changing
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Structure of • Global Regulatory Affairs
Regulatory • Regional Regulatory Affairs
Affairs • Local Regulatory Affairs
• Manufacturing Site Regulatory
Affairs
• Drug Agency Regulatory
Affairs
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Module 2
The role of Regulatory Affairs department
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Regulatory affairs professionals are
employed in industry, government
regulatory authorities and
REGULATORY academics. The wide range of
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regulatory professionals includes in
AFFAIRS these areas:
PROFESSIONAL
• Pharmaceuticals
IN INDUSTRIES • Medical devices
• In vitro diagnostics
• Biologics and biotechnology
• Nutritional Products
• Cosmetics
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Approval Phase
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Development Post Approval
Phase Phase
Role of
Drug
Regulatory
Affairs
Department
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Role of Drug Regulatory Affairs Department
A. Development Phase
Ensuring that the legislative requirements are met –
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- Advice on development studies to demonstrate safety, quality and efficacy parameters.
- Set up regulatory strategy.
- Participate in cross-functional project teams.
- Ensure application of guidelines for clinical trials.
- Submission of application to conduct clinical trials.
- Managing the regulatory submission -
- Minimize time to market (everyday counts!)
- Advice on a global development plan
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Optimize submission strategies -
– Dossier preparation
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– Format, document re-use
– Electronic submissions
– Review high-level documents/reports
Interact with commercial side of business such as pricing and reimbursement.
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Regulation of drug approval process
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B. Approval Phase
Clarify raised questions,
Check progress of
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plan response and
evaluation and anticipate
strategies with other
questions.
departments.
Negotiate approval and
Plan and manage agency
Product Information with
meetings/hearings.
agencies.
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1. Discovery/
development
Team
2. Nonclinical
7. pharmacology
and toxicology
Management Team/ 3.
Team Clinical
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research Team
Regulatory
requirements
for drug
approval
4. Regulatory
6. Legal Team
affairs Team
5. Marketing
Team
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C. Post approval Phase
Compliance
Submission of variations/amendments
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Renewals
Pharmacovigilance
Product information review
New indications / new formulations
Regulatory input to development plans/ Regulatory Intelligence.
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Responsibility of the Regulatory Affairs Professionals –
Ensuring that their companies comply with all the regulations and laws
Working with federal, state and local regulatory agencies and personnel
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Advising companies on the regulatory aspects
Keep in touch with international legislation, guidelines and customer practices
Keep up to the date with a company’s product range
Collect, collate, and evaluate the scientific data that their research and development
Formulate regulatory strategies for all appropriate regulatory submissions such as domestic,
international and/or contract projects
Coordinate, prepare and review all appropriate documents for example dossier and submit them to
regulatory authorities
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Prepare and review Prepare and review of SOPs
Review Review of BMR, MFR, change control and other relevant documents.
Monitor Monitor the progress of all registration submission
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Maintain Maintain approved applications and the record of registration fees paid
Respond Respond to queries and ensure that registration/ approval are granted
Participate in R&D training, Pilot plant Scale Up, and Post Marketing Surveillance
Participate in (ADR)
Manage and review audit reports and compliance, regulatory and customer
Manage and review inspections
Provide accurate and complete information about the quality, safety and
Provide effectiveness of the product to the physicians and other healthcare professionals.
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