New Chemical Entity

New Chemical Entity Definition & Introduction

New Chemical Entity: Definition & Introduction

New Drug Products (NDP) is defined as any pharmaceutical products that have not been previously registered in accordance with the provisions of the CDCR 1984.

An NDP may be classified according to the following categories:

a) New Chemical Entity (NCE)/ Radiopharmaceutical Substance

A new pharmaceutical product containing any of the following:

i. New Chemical Entity (NCE)

Defined as an active moiety that has not been registered in any pharmaceutical product.

ii. Radiopharmaceutical substance

Defined as a radionucleotide, ligand or the coupling mechanism to link the molecule and the radionucleotide that has not been registered in any pharmaceutical product.

b) New Combination Product

A new pharmaceutical product containing two or more drugs that are physically, chemically or otherwise combined or mixed and produced as a single pharmaceutical product, in a combination that has not been registered in any other pharmaceutical product. This includes any of the following:

i. Combination of New Chemical Entities;

ii. Combination of registered chemical entity(s) AND New Chemical Entity(s);

iii. Combination of registered chemical entities;

iv. Combination of registered chemical entities in a new chemical forms;

v. Combination of registered chemical entity(s) in new chemical form(s) AND New Chemical Entity(s);

vi. Combination of registered chemical entity(s) in new chemical form(s) AND registered chemical entity(s).

c) Supplemental Product

A new pharmaceutical product containing a drug that has been previously registered as a pharmaceutical product but differing in properties with regards to safety and/or efficacy from the product that has been previously registered.

This includes any of the following:

i. Registered chemical entity in a new chemical form;

ii. Registered chemical entity in a new dosage form;

iii. Registered chemical entity in a new dosage strength with a change in dosing/ posology;

iv. Registered chemical entity for use by a new route of administration;

v. Registered chemical entity for new indication(s), dosage recommendation(s) and/or patient population(s).

Recent Updates, Directives & Circulars


  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for New Chemical Entity
  • Directives & Circulars Related to New Chemical Entity

Product Registration Process

Step I : Preparation

Product classification, Token Configuration, Payment Mode, Patent and Data Exclusivity status and Ensure key documents availability.

Pre-submission of Application (Preparation)

Step I : Preparation

Step 2 : Submission

Key-in, upload documents and submit your application (Part I, Part II, Part III & Part IV)

Product Validation, Part I, Part II, Part III & Part IV

Step 2 : Submission

Step 3 : Regulatory Outcome

Evaluation of Application & Drug Control Authority (DCA) decision.

Evaluation of Application & Drug Control Authority (DCA) decision.

Step 3 : Regulatory Outcome

Step 4 : Post-registration Process

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Step 4 : Post-registration Process

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Wednesday 21 August 2019, 09:55:47.
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