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Q.1 How long does it take for my application submitted under the primary evaluation route to be evaluated?
A.1
A target timeline for the review process of a new drug application (NDA) via primary evaluation route has been set.
The target processing time - i.e. the time period between the acceptance of an application upon payment of the prescribed fee and the first decision made by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances) Committee (Registration Committee) - of new drug application via primary evaluation route is 220 working days. Under the target processing timeline, the "stop-clock" will be paused as evaluation of the application is paused upon request for written response sent to the applicant for supplementary documentary evidence. The "stop-clock" and evaluation of the application will be resumed upon receipt of a response from the applicant.
Meanwhile, the "stop-clock" will also apply to you as the applicant in that it starts when you are requested for supplementary evidence and pauses when you submit a response accordingly. Your "stop-clock" period ends if complete and satisfactory supporting evidence has been provided or the total response time exceeds 150 calendar days.
For details, please refer to the "stop-clock" mechanism for new drug applications via primary evaluation route.
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Q.2 How will my applications for initial registration of pharmaceutical products I submitted before 31 March 2026 and have not been approved yet, be processed?
A.2
The new and revised guidance notes for phase 1 of primary evaluation take effect on 31 March 2026. They are applicable for applications accepted for evaluation on or after 31 March 2026.
For your applications which have been accepted for evaluation prior to the effective date of the new and revised sets of guidance notes (i.e. 31 March 2026), the previously effective guidance notes namely, Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity (Version Nov 2024) and Guidance on Application of Certificate of Drug/ Product Registration – Advanced Therapy Products (Version 3.1), remain applicable for one year until 30 March 2027.
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Q.3 Can I switch to another evaluation route for my submitted applications when additional certificates of pharmaceutical products issued by the drug regulatory authorities of the reference places are obtained?
A.3
Once your new drug application meets the eligibility criteria and is accepted for evaluation, you cannot alter the selected evaluation route during the evaluation process.
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Q.4 Do the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q1 guidelines on stability apply to all applications?
A.4
With effect from 31 March 2026, you should include evidence demonstrating compliance with the stability requirements of the current ICH Q1A-E guidelines in all your initial applications for registration of the following product types:
- products containing new chemical or biological entity;
- products containing a new salt, ester or non-covalent-bond derivative of approved drug substance;
- products with a new dosage form.
Applications that do not meet this requirement will not be accepted for evaluation.
Please refer to the relevant guidance notes for the registration requirements on stability of your applications.
For new drug applications, you have to submit stability test data of drug substance and drug product (ICH Common Technical Document Modules 3.2.S.7 and 3.2.P.8), and in-use stability data (if applicable), in accordance with ICH Q1A(R2), Q1B, Q1C, Q1D, and Q1E.
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Q.5 Quality information of the drug substance (ICH Common Technical Document Module 3.2.S) of my new drug application is uploaded in the Pharmaceuticals Registration System (PRS2.0). Are these pieces of information related to the drug substance considered as registered particulars when the product is approved for registration?
A.5
There have not been associated changes for the registrable particulars of pharmaceutical products under Regulation 36 of the Pharmacy and Poisons Regulations, Cap. 138A (the “Regulations”) since the introduction of new application categorization and implementation of phase 1 of primary evaluation. Please refer to provisions for the registrable particulars of pharmaceutical product under the said Regulation.
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Q.6 How are NDA-2 and NDA-3 different from applications for change of registered particulars?
A.6
NDA-2 and NDA-3 are applications for initial registration of pharmaceutical products under Regulation 36 of the Regulations. The applications will be approved with new drug product registration numbers.
When submitting an NDA, you have to select the correct category and provide the relevant supporting documents. Taking NDA-3 as an example, you should submit an application dossier containing the same information as that submitted for a product registered as NDA-1, NDA-2 or product containing new chemical or biological entities before 31 March 2026, except for the specified change(s), e.g. a different manufacturer on the product label.
On the other hand, Regulation 36 of the Regulations stipulates that when a pharmaceutical product is registered, certain particulars are registered with the Pharmacy and Poisons Board. If you are a holder of a registration certificate of a pharmaceutical product and wish to apply for the change of certain registered particulars of your registered product, you may do so in accordance with Regulation 36A of the Regulations.
In other words, you can only apply for change of registered particulars for an already registered product while an NDA is a separate application for initial registration of a pharmaceutical product.
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Primary evaluation FAQ
