Biopharmaceuticals, or biologics, are intricate therapeutic products derived from living organisms or biological systems. The regulatory pathways for these innovations are rigorous, ensuring safety, efficacy, and quality. The process involves preclinical development, IND application submission, and three phases of clinical trials. Successful trials lead to NDA or BLA submission, followed by regulatory review by agencies like the FDA or EMA. Approval allows the biopharmaceutical to enter the market, with post-marketing surveillance ensuring continued safety and efficacy. Collaboration among regulatory authorities, sponsors, and experts is pivotal for successful development and approval, upholding high standards of patient safety and product quality.

1. Mangesh Patil PM 30
PGDM Pharmaceutical Management
SIES College of Management Studies
Biopharmaceutical
Regulatory Pathway
biopharmaceuticals and nutraceuticals

2. Introduction
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3. Introduction
 Top 12 global destination.
 largest suppliers of low-cost drugs and vaccines in the world.
 contribute $500 million to $600 million in the $12 billion global
market.
 1.5% of the worldwide demand for biosimilar.
 CAGR of 24%, biosimilar are expected to be a $36 billion global
opportunity by 2025.
 $550 million to $600 million worth of biosimilar drugs sold in domestic
market.

4. Registration of Biopharmaceutical Products
Basic Research
Drug
Discovery
Preclinical
development
Clinical Trials
Phase I,II,III
Manufacturing
IND (submission
and review)
BLA/NDA (submission
and review)
Post marketing
surveillance
Safety , Quality and Efficacy

5. Regulatory
Authority
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6. • Center for biologics evalution and research (CBER) is the center within FDA that
regulates biological products for human use under applicable Federal laws including
the Public Health Services Act (PHS) and the Federal, Food, Drug and Cosmetics Act
• CBER protects and advances the public health by ensuring that biological products
are safe and effective.
• FDA's regulatory authority for the approval of biologics resides in (PHS) Act.
• Some medical devices which are used to produce biologics are regulated by CBER
under FD&C Act’s medical device amendments of 1976
• It protects against threats of emerging infectious diseases.
• It provides the public with information to promote safe and appropriate use
Regulatory Authority For Biopharmaceuticals in India

7. Regulatory authorities in Biopharmaceuticals
Regulatory oversight of biopharmaceuticals, which are medicinal products produced using biotic
factors such as living cells or organisms, involves several key authorities globally. Some
prominent regulatory bodies includes
1. Food and Drug Administration (FDA): In the United States, the FDA is responsible for
ensuring the safety and efficacy of biopharmaceuticals through a rigorous approval process.
2. European Medicines Agency (EMA): In the European Union, the EMA plays a central role in
evaluating and approving biopharmaceuticals, ensuring they meet high standards of quality,
safety, and efficacy.
3. Health Canada: In Canada, Health Canada oversees the regulation and approval of
biopharmaceuticals to ensure their safety and effectiveness.
4. Japan Pharmaceuticals and Medical Devices Agency (PMDA): Japan's PMDA is responsible
for evaluating and approving biopharmaceuticals to ensure their quality, safety, and efficacy.

8. Regulatory authorities in Biopharmaceuticals
5. World Health Organization (WHO): The WHO provides international guidelines and
standards for the development, production, and regulation of biopharmaceuticals, influencing
regulatory practices globally.
6. China National Medical Products Administration (NMPA): In China, the NMPA
regulates the approval and oversight of biopharmaceuticals to ensure their quality and safety.
These regulatory authorities collaborate to establish global standards and guidelines for the
development and approval of biopharmaceuticals, contributing to the safety and efficacy of
these advanced medical products.

9. EMA Guidelines
The European Medicines Agency (EMA) provides guidelines specific to the European
Union, including:
• Guideline on Similar Biological Medicinal Products.
• Guideline on Immunogenicity Assessment of Therapeutic Proteins.
• Guideline on Non-Clinical and Clinical Development of Similar Biological
Medicinal Products Containing Recombinant Interleukin-2.
Good Manufacturing Practice (GMP)
Compliance with GMP is crucial for the manufacturing of biopharmaceuticals. Guidelines,
such as FDA's cGMP for the 21st Century and EMA's GMP guidelines, provide standards for
the production of pharmaceuticals, including biologics.

10. FDA Guidelines
The U.S. FDA provides specific guidance documents for various aspects of
biopharmaceutical development, including:
• Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference
Product.
• Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic
Protein Product to a Reference Product.
• Guidance for Industry: Clinical Immunogenicity Considerations for Biosimilar and
Interchangeable Insulin Products.
• Guidance for Industry: Development of Therapeutic Protein Biosimilars.
Biosafety Guidelines
Guidelines on biosafety, particularly for gene and cell therapies, are essential. These may include
considerations for viral vectors, gene editing, and cell-based therapies.

11. • In India, the regulation and guidelines for biopharmaceuticals are primarily governed by the
Central Drugs Standard Control Organization (CDSCO) under the provisions of the Drugs
and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
• The CDSCO, which operates under the Ministry of Health and Family Welfare, is responsible
for the approval, regulation, and quality control of pharmaceuticals, including
biopharmaceuticals.
• Biopharmaceutical drug evaluation and approvals are undertaken by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research
(CBER). CDER regulates the development and marketing process of mainly chemical-based
drugs; CBER regulates biologics.
Biopharmaceutical India Regulations and Guidelines

12. Thanks