New Chemical Entity

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 NCE (single/ combination products with an active substance never registered by DCA)

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

An active moiety is defined as the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an        ester, salt (including a salt with hydrogen or coordination bonds) or other noncovalent derivative (such as complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.

A radiopharmaceutical substance is 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) Hybrid NCE (single/ combination products with registered active moieties)

All other products registrable at New Drug Section which do not fall under (a).

Examples of Hybrid NCE (combination) products:

i. Combination of registered chemical entities

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

iii. Combination of registered chemical entity(s) in new chemical form(s) and registered chemical entity(s)

Examples of Hybrid NCE (single) products:

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)

vi. A generic product for which its innovator has never been registered by DCA

NOTE:

For a generic product in which the reference innovator product has never been registered in Malaysia, specific requirements for Parts III and IV:

i) Nonclinical Overview, Nonclinical Summary & List of Key Literature references, by referring to studies by the innovator product

ii) Clinical Overview, Clinical Summary & List of Key literature References, by referring to studies by the innovator product

iii) Bioequivalence study report(s)

iv) other pivotal study reports, if applicable

v) Risk Management Plan (RMP)

vi) Consultation with local clinical specialists