The New Drug Application (NDA) is the vehicle through which drug sponsors such as organizations, pharmaceutical companies formally propose that the FDA approve a new Phytopharmaceuticals for sale and marketing. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines to regulate the marketing of herbal drugs.

1. Quality Control & Standardization Of Herbals
Preparation Of Documents For New Drug Application
By
Kaushal Kumar

2. Tabel Of Contents
01 02 03 04
Introduction Document Requirements NDA Chart

3. The New Drug Application (NDA) is the vehicle through which drug
sponsors such as organizations, pharmaceutical companies formally
propose that the FDA approve a new Phytopharmaceuticals for sale
and marketing.
Every country has its own regulatory authority, which is responsible to
enforce the rules and regulations and issue guidelines to regulate the
marketing of herbal drugs.
The documentation required in an NDA is supposed to tell the drug's
whale story including, what happened during the clinical tests, what
are the ingredients of the drug, the results of the animal studies, how
the drug behaves in the body, and how it is extracted/isolated,
manufactured, processed and packaged, so that they are safe and
patient's well-being is protected.
Introduction

4. Documents
Preparation of Documents for New Drug Application (NDA) in India
FDA Botanical Drug Development Guidance describes appropriate development plans for
botanical drugs to be submitted in NDA & specific recommendations on submitting Investigational
New Drug applications.
The term botanical means products that include – Plant materials, algae, macroscopic fungi and
combinations.
FDA guidance recommends that IND must contain sufficient information to demonstrate that the
drug is safe for testing in humans and that the clinical protocol is properly designed for its
intended objectives.
 Special requirements to ensure the safety and quality of botanicals as follows:
 Description of product and documentation of prior human experience.
 Description of botanical raw materials used and known active constituents or chemical
constituents.

5. Special Requirements
 Special requirements to ensure the safety and quality of botanicals as follows –
Description of product and documentation of prior human experience.
Description of botanical raw materials used & active constituents or chemical constituents.
Quality Control
 Botanical Raw Material
 Botanical Drug Substance & Drug Product – Identity, chemical characteristic, manufacturing
processes, biological assay, specifications, stability, cGMP & environmental hazard.
Evidence to ensure therapeutic consistency
⭧ Botanical raw material control test
⭧ Quality control by chemical test(s) and manufacturing control
⭧ Biological assay
⭧ Clinical data
⭧ Dose-response data and multiple batch clinical data.

6. Special Requirements
 The regulatory requirements for NDA for the phytopharmaceutical drug include –
Standard requirements for a new drug-safety and pharmacological information, human studies
and confirmatory clinical trials.
Data generated on
 Identification, authentication and source of the plant used for extraction and fractionation.
 Process for extraction and subsequent fractionation and purification.
 Formulation details of the phytopharmaceutical drug.
 The manufacturing process of formulation.
 Stability data.

7. Special Requirements

8. THANKS!
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