Frequently Asked Questions (FAQs) : Active Pharmaceutical Ingredient (API)

A) API in New Product Applications

1. What is the definition of API
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used, so becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease of disease or to affect the structure and function of the body (World Health Organization (WHO).
2. What are the categories of products under the scope of API regulatory control?
3. What are the categories of products that do not fall under the scope of API regulatory control?
4. When is the implementation date for API regulatory control?
5. Is a separate registration required for the API only?
6. How much is the processing fee?
7. What is the timeline for API evaluation?
8. Who should submit the API documents?
9. What is the maximum file size acceptable for uploading into the online module?
10. How can I submit the DMF to NPRA?
11. What are the GMP requirements for the API manufacturer?
12. How should the documents be submitted when a finished product contains more than one API or more than one API manufacturers?
13. Do applicants need to submit samples of the API to NPRA?
14. Following the restructuring of NPRA (effective 2 Dec 2019), what will be the changes in API evaluation?
15. Whom shall we submit the Drug Master File (DMF) to?

B) API in Registered Products


i) Category of Product: Anti-Infectives

1. When can we start to submit API documents to support product registration renewal?

Section S revision shall be submitted to New Drug Product Section or Generic Medicine Section 12 to 15 months prior to expiry of product registration period. Any submissions other than the indicated period will not be accepted. 

2. What is "Section S Revision" and "Product Editing"?

"Section S Revision" is the terminology used for the administrative procedure for the implementation of regulatory control of API in registered product exipiring starting 1 Jan 2020.
"Product Editing" is the sub-module in QUEST3+ that enables updating of API information with the exercise of Section S Revision.

3. Can we submit for “Section S Revision” earlier than 15 months prior to expiry of product registration period?

No. Any submissions other than the indicated period will not be accepted.

4. How will I know if NPRA has received my online submission of Form RegA2?

Once applicant has completed the online form and click the “submit” button, a pop-up notification will be received indicating a successful submission. In addition, a copy of the submitted form will be emailed to the recipient of email address entered in Form RegA2.

5. How long does it take to process my application to enable “Section S Revision” in Quest 3+?

Within 15 calendar days. Please refer to schedule of enabling Section S Revision in Quest 3+.

6. What are the requirements for “Section S Revision” for registered products? Since this product has been in the market for some time, are the requirements less lenient than new product registration?

Please refer to summary of required documents in Guidance Note for API Information: Appendix 1: API submission Checklist.

7. Can I submit for “Section S Revision” if the product has pending variation approval?
No, Quest 3+ system disallow any product with more than one ongoing process at one time (i.e. variation/evaluation/section S revision/renewal etc.). Thus, applicants shall plan the submission for each process, so that it does not overlap.
However, If there is an ongoing variation at the time of renewal, please submit Form Reg A2, and indicate in the remark column the variation call number. The API officer will communicate with the applicant on this matter. 
 
8. Can I submit for “Section S Revision” if there are changes in name and address of API manufacturing site?

No. If there are any changes in name and address of API manufacturer, or change of API specification, please submit a variation application. Please note that “Section S Revision” is not a platform to submit post-approval changes.  Post-approval changes shall comply to Malaysian Variation Guidelines. Section S Revision is a procedure to allow submission of Part II S information for unregulated APIs as required by the Directive of Regulatory Control of API (BPFK/PPP/07/25(7)) dated 16 Jan 2014.

9. If a finished product containing TWO APIs, where only one active ingredients is an anti-infective, shall we perform Section S Revision through separate procedure and using different requirement?

The regulatory control of API is based on product category. This kind of product will be classified as anti-infective. Thus, both APIs should be submitted through single procedure and should follow the same requirement i.e. Anti-Infective

10. How to confirm if an API is categorised as anti-infectives or non-anti-infectives?

Please refer to the ATC code for confirmation.

11. Do I still need to perform Section S Revision if all Part II S information in QUEST system is up-to-date/ no changes since approval/ Data Cleaning/ Variation Approval (for unregulated API)?

Applicants are only required to submit Form Reg A2 for the case mentioned. When submitting Form Reg A2, please fill in product information and “tick” the option of “No Changes Made Since Data Cleaning / Registration / Variation Approval” in Page 3 of Form Reg A2. After verification by NPRA officer, this product will be remarked as “fulfilled Section S Revision”. Therefore, “Product Editing” via QUEST system is not required.

ii) Category of Product: Non Anti-Infectives

1. With the change in administrative procedure effective 17 Dec 2019, does this means that we do not need to fulfil API requirements for Non Anti-infectives Products?

It is Product Registration Holder's (PRH) responsibility to ensure that the API used in the finished product fulfills NPRA’s requirement. PRH is responsible to ensure that all required API information are available on hand. This information shall be kept safe with the PRH without uploading into QUEST3+. With this change, NPRA hopes to reduce administrative work at both ends. However, when required, NPRA reserve the right to request PRH to provide required API information within a given timeframe.

2. What are the API requirement for Non Anti-Infectives Products to be kept by PRH?
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Foot Note:

X - Optional

/ - Required
3. If a finished product containing TWO APIs, where only one active ingredient is an anti-infective, what category it shall be considered as?

The regulatory control of API is based on product category. This kind of products will be classified as anti-infectives. Thus, both APIs should be submitted with the requirement as stated in Guidance Note for API Information: Appendix 1.

4. Can we still request to perform “Product Editing” for Non anti-infective APIs?

No. The change of administrative procedure aims to reduce administrative workflow. "Product Editing" are strictly for Anti-Infective products  undergoing Section S Revision only. Products that require “data cleaning” will not be entertained.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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