FAQ NCE

NCE Frequently Asked Questions (FAQs)

FAQs for NDP

• English

Posted: 04 December 2019

Analytical Testing and Labelling Declaration Requirements for Products Containing Animal-Derived Materials

• English

Posted: 22 April 2026

Frequently Asked Questions (FAQs) : BIOEQUIVALENCE

• English

Desktop Evaluation on The Need of BE Study Specific Inspection

• English

Posted: 28 February 2023

FAQs: New/Hybrid Radiopharmaceutical Products

• English

Posted: 26 June 2026

NCE Frequently Asked Questions (FAQs)

FAQ for NCE option 2

FAQs for NDP

1)    What is NDP?

Answer:

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 a 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:

1. Combination of registered chemical entities
2. 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:

1. Registered chemical entity in a new chemical form
2. Registered chemical entity in a new dosage form

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

1. Registered chemical entity for use by a new route of administration
2. Registered chemical entity for new indication(s), dosage recommendation(s) and/or patient population(s)
3. A generic product for which its innovator has never been registered by DCA

Flowchart to determine NDP classification, registration requirement and evaluation timeline:

2)    Is there any other pathway for product registration other than the normal pathway?

Answer: Yes.

1.         Full Evaluation (Conditional Registration)

• Applies to new registration applications for New Drug Products and Biologics
• At the point of submission, the product must be registered in at least one Drug Control Authority (DCA) reference agencies
• A conditional registration does not apply to additional indications submitted post-registration
• Once a product has been granted a full registration that is not subjected to any specific conditions, the full registration approval cannot be reverted into a conditional registration approval. However, the approval of additional indication with less than comprehensive clinical data may be considered on case-to-case basis
• A conditional registration is valid for two years. Thereafter, the conditional registration may be renewed 2 times (with the possibility of 2 extensions of 2 years each)
• Please refer to the Guidelines On Conditional Registration For New Chemical Entities And Biologics for further details

Directive No. 15 Year 2018. Ref. BPFK/PPP/07/25 (15) Jld 2 : Direktif Untuk Melaksanakan Guidelines On Conditional Registration For New Chemical Entities And Biologics

1.         Full Evaluation via Abbreviated and Verification Review

• Applies to New Drug Products and Biologics including biosimilars
• Abbreviated Review applies to a product that has been evaluated and approved by one (1) reference drug regulatory agency
• Verification Review applies to a product that has been evaluated and approved by two (2) reference drug regulatory agencies
• For details, please refer to Guidelines on facilitated registration pathway: abbreviated and verification review. The guideline provides information on the eligibility criteria, procedures and requirements for submitting application to register a product via abbreviated or verification review. The implementation of the guideline was on 1 April 2019.

Directive No. 7 Year 2019. Ref. BPFK/PPP/07/25 (7) Jld 3: Direktif Untuk Melaksanakan Guidelines On Facilitated Registration Pathway: Abbreviated And Verification Review

                   iii.        Abrdiged Evaluation

3)    What are the related guidance documents for registration of NDP in Malaysia?

Answer:

1.         Drug Registration Guidance Document (DRGD)
2.         International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use

                    iii.        Malaysian Pharmacovigilance Guidelines

1.         The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals for Human Use
2.         The ASEAN Common Technical Requirements (ACTR)

-       ASEAN Guideline on Stability Study of Drug Product

-       ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration

-       ASEAN Guidelines for Validation of Analytical Procedures

-       ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies

-       ASEAN Variation Guideline for Pharmaceutical Prodcuts

Please also refer to this link for the guidelines available on the NPRA website:

https://www.npra.gov.my/index.php/en/nce-guidelines.html

4)    Is the Risk Management Plan (RMP) required for a New Drug Application?

Answer: Yes it is a requirement. Kindley refer to the Malaysia Pharmacovigilance Guidelines (2016 edition) for information on RMP.

P5.5 SITUATIONS WHEN A RISK MANAGEMENT PLAN SHOULD BE SUBMITTED

P5.5.1 RMP for New Drug Products/Biologics

1.        An RMP or an update, as applicable, may need to be submitted at any time during a product’s life-cycle.
2.       RMP or an update will normally be expected, with an application involving a significant change to an existing registered product:

• New dosage form;
• New route of administration;
• New manufacturing process of a biotechnologically-derived product;
• Paediatric indication;
• Other significant change in indication

               iii.      A significant change in indication is a change of approved indication(s) of a product where the new treatment target population differs materially from the one for which the product was previously approved. This includes (but is not limited to):

• A new disease area, a new age group (e.g. paediatric indication),
• A move from severe disease to a less severely affected population,
• 2nd line or other therapy,
• At the request of the Authority when there is a concern about a risk affecting the benefit-risk balance,
• At the time of the renewal of the product registration if the product has an existing risk management plan. An updated RMP should always be submitted if there is a significant change to the benefit-risk balance of one or more medicinal products included in the RMP.

5)    What are the requirements for hybrid products?

Answer: The requirements include dossier for:

• Part I (CD and hardcopy)
• Part II (CD and hardcopy)
• and Part IV (CD only)

*The non-clinical overview (Part III – CD only) may be provided as supporting documents.

*9 sets of proposed package inserts and published clinical papers/ in-house synopses for the pivotal clinical studies may need to be provided on a case-to-case basis.

6)    Would NPRA require local clinical studies upon registration process for NDP/NCE?

Answer: No. The clinical studies need not necessarily be done locally.

7)    For product applications with bioequivalence studies, what is/ are the reference product(s)/ comparator(s) needed to conduct the studies?

Answer: Kindly refer to the NPRA website        Industry        Generic Medicines

      Bioequivalence        Generic Product List for BE studies       Refer to the related list (download).

Kindly refer to this link to refer to the reference product(s)/ comparator(s):

https://www.npra.gov.my/index.php/en/generic-product-list-for-be-studies

8)    What are the guidelines to refer to, for clinical development studies for combination products application?

Answer: These guidelines may be referred to:

1.        EMA Guideline on clinical development of fixed combination  medicinal products.

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/03/WC500224836.pdf

1.       US FDA Combination Products Guidance Documents

https://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm

9)    What are the documents required after the payment for the NDP application has been confirmed?

Answer: Kindly make an appointment with the respective officer to submit the dossier. The required documents include:

1.              Complete Part I (Adminsitrative documents) – hardcopy and CD.
2.             Complete Part II (Drug Product) - hardcopy and CD.

                          iii.            Complete Part III (Non-clinical Documents) – CD.

1.             Complete Part IV (Clinical Documents) – CD.
2.              9 sets of proposed package inserts and published clinical papers/ in-house synopses for the pivotal clinical studies only for new products.

FAQs for Appendix 19 General Labelling Requirement for Products Containing Animal-Derived Materials

1. What is the purpose of implementation?

The primary purpose of the declaration requirement is to provide transparent information, enabling patients to make informed decisions about their treatment while upholding the sensitivity of public interest.

The revision to Clause 17 under Appendix 19 aims to provide flexibility for applicants who refuses to declare the animal origin statement on the product label, provided they can offer satisfactory confirmation, subject to NPRA's discretion. Please note that this is not a mandatory document or test; it only applies to those who decide not to declare the animal origin statement on the product label. This requirement has been in effect since 2007 and is not constitute a new or additional registration requirement.

Therefore, these amendments will not have any impact on the accessibility or availability of the product in market and should be regarded as a clarification of the existing country-specific requirements. Applicants are encouraged to include the declaration on the label if the necessary testing is not intended to be conducted.

2. What types of products are involved?

The requirement for the declaration of animal-derived materials applies to both pharmaceutical and natural products and covers the entire final product, including the container closure system, also known as primary packaging. Primary packaging is defined as packaging that comes into direct contact with the drug product.

For biologic/biopharmaceutical products that commonly use animal-derived materials in their manufacturing processes, which differ from the manufacturing processes of pharmaceutical and natural products, the circular NPRA.600-1/9/12 (20) dated 24^th May 2023; The Requirements of Deoxyribonucleic Acid (DNA) Testing for Biological Products That Use Animal-Derived Materials, applies.

3. What is the scope of implementation?

The requirement for the declaration of animal-derived materials has been in place since 2007, as outlined in the Drug Registration Guidance Document under Appendix 19: General Labelling Requirements. This applies to all products undergoing evaluation, including new registrations and variations. Reassessment of currently registered product labels is not required unless a variation or other relevant issue necessitates label changes.

4. Is there a grace period to comply with the requirements for registered products?

The policy has been in effect since 2007, as outlined in the Drug Registration Guidance Document under Appendix 19: General Labelling Requirements. The amendment (circular (NPRA.600-1/9/12(25)) aims to clarify Clause 17 under Appendix 19 by considering the need to submit satisfactory confirmation verifying the absence of animal materials if the applicant chooses not to include a declaration on the product label.

As this is an existing policy, no grace period is provided to comply with the requirements. If variation is required, a variation application under MiV-PA2 (Change of Drug Product Labelling in accordance with country-specific labelling requirements) need to be submitted.

5. What kind of scientific evidence is accepted by NPRA should the applicant refuses to declare the animal-derived materials on product label?

During product dossier submission for registration, the applicant is required to provide information regarding the use of animal-derived materials throughout the manufacturing process of the product. If animal derived materials were used, a declaration on the product label is required unless scientific evidence verifying the absence of animal materials can be provided.

The scientific evidence can be product-specific and will be subject to further review of the justification and documentation provided by the applicant to the NPRA. For example, a DNA PCR test can be accepted as satisfactory confirmation verifying the absence of animal materials in the final product. Alternatively, justification or a declaration issued by the product manufacturer / owner regarding the manufacturing process or processing methods (e.g., purification, etc.) used to remove animal-derived materials from the product can be provided as scientific evidence.

However, please note that for pharmaceutical and natural products, the scientific evidence for animal-derived materials, particularly those from porcine and canine sources, is subject to the guidelines outlined in NPRA Circular NPRA.600-1/9/12 (20), dated 24th May 2023, titled The Requirements of Deoxyribonucleic Acid (DNA) Testing for Biological Products That Use Animal-Derived Materials. This circular should be read together with the accompanying FAQ for a comprehensive understanding of the requirements.

6. Are there any exemptions granted?

Clause 17 of Appendix 19, General Labelling Requirements, does not apply to low-risk or commonly used materials intended for human consumption, such as lactose, milk derivatives, beeswax in ointment products and printing/colouring inks derived from insect sources. This list is not meant to be exhaustive and will be reviewed from time to time.