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

Drug Registration Guidance Document : Second Edition – September 2016, revised July 2018

PREAMBLE

  • This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products. This document will replace the “DRUG REGISTRATION GUIDANCE DOCUMENT” Second Edition, September 2016.
  • This DRGD shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing pharmaceutical and natural products for human use in Malaysia, which include but not limited to the following:

a) Sale of Drugs Act 1952;
b) Control of Drugs and Cosmetics Regulations 1984;
c) Dangerous Drugs Act 1952;
d) Poisons Act 1952;
e) Medicines (Advertisement & Sale) Act 1956;
f) Patents Act 1983;
g) Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
h) International Trade in Endangered Species Act 2008 (Act 686).
The written laws shall take precedence over this guidance document in any event of discrepancy.

 
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DRGD Update

List of DRGD Updates Download
List of DRGD Updates - October 2018 October 2018
List of DRGD Updates - August 2018 August 2018
List of DRGD Updates - July 2018 July 2018
List of DRGD Updates - June 2018 June 2018
List of DRGD Updates - April 2018 April 2018
List of DRGD Updates - March 2018 March 2018
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised January 2018 January 2018

Product Registration Process

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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

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