New Chemical Entity
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 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
Recent Updates, Directives & Circulars
- Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for New Chemical Entity
- Directives & Circulars Related to New Chemical Entity
Announcement to Product Registration Holders (PRHs): Revision of Categories and Criteria for New/Additional Indication Application – A Pilot Study |
Application Forms Biologics |
Registration Application Submitted via Facilitated Registration Pathway (FRP) - FAQs |
Orphan Medicines Approved |
Revision of timelines for variation applications of registered products [pharmaceutical products & natural and health supplement products (TMHS)] and a pilot study |
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 : PreparationStep 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 : SubmissionStep 3 : Regulatory Outcome
Evaluation of Application & Drug Control Authority (DCA) decision.
Evaluation of Application & Drug Control Authority (DCA) decision.
Step 3 : Regulatory OutcomeStep 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