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?

B) API in Registered Products

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

Section S revision shall be submitted to API Section 12 to 15 months prior to expiry of product registration period. Any submissions other than the indicated period will not be accepted. However, applicants are still required to apply for product registration renewal to Regulatory Coordination Section since revision of Part II S information is only part of the requirement for product registration renewal.

2. How long does it take to get approval for the “Section S revision” before we can apply for product registration renewal?

Submission of API Information shall be made 12 to 15 months prior to expiry of product registration period. Application for renewal can be made after completing “Section S Revision” via QUEST 3+. The product renewal application will be affected by the outcome of API Submission/ Evaluation.

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 RegA1?

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 RegA1.

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 for Section S Revision for registered products:
Annex 1: API Submission Checklist for Registered Product

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, for special condition whereby applicant may not be able to meet the window between Section S Revision (12 months before renewal) and variation approval, applicant may email to apireg@npra.gov.my to request for extension for Section S Revision (**subject to approval by Head of API Section).
**Note- this special condition is strictly for products currently under evaluation for variation application.

 

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8. 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

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

Please refer to the ATC code for confirmation.

10. Can I apply for variation after completed "Section S Revision" editing?

There is no restriction for variation application for Part P. However, variation application pertaining to Section S is discouraged for 1 year after Renewal, since Section S information has just been revised and should be up-to-date. Variation application for Section S due to contingency and crisis issues are acceptable. 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Jumaat 20 September 2019, 16:39:36.
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