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Active Pharmaceutical Ingredient (API)

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. Why the NPCB needs to control API?

Mandatory control of API can reduce the risk of sourcing substandard or contaminated materials to ensure a constant sourcing of active ingredient of appropriate quality and will safeguard the public.

3. What are the categories of product under the scope of API control?

a) New Drug Product
b) Generic Product containing Scheduled Poison
c) Generic Product NOT containing Scheduled Poison

*It is only applicable for the new product registration application.

4. What is the category of product that does not fall under the scope of API control?

The following categories of product are excluded from API control:

Traditional product,
Veterinary product
Health supplement product, 
Biological and biotechnology product.

5. When is the implementation of the API control?

The implementation began with voluntary submission for New Drug Products in April 2011 and followed by;

· Phase 1 - New Drug Products (January 2012) 

· Phase 2 - Scheduled Poison

a) New Application (Generic Product):-
i. Parenteral Dosage Form : 1 July 2014
ii. Oral Dosage Form : 1 July 2016
iii. Others : 1 July 2018

b) Registered Product (Pharmaceutical products containing Scheduled Poison):-
All Dosage Form : Expire on 1 January 2020 onwards
Phase 3 - Generic Product NOT containing Scheduled Poison (to be determined)

6. If products intended solely for exportation purposes, are they required to submit DMF or CEP for API application?

API used in product for export only (FEO) is exempted from submitting the DMF or CEP in product application.

7. What is the procedure for API application?

Separate registration of the API is not a requirement for the purpose of product registration. However, the required technical documentation pertaining to each API should be submitted with the online product 
registration application.

8. How much is the processing fee?

Not required as the API application is already incorporated in the product registration application.

9. What is the timeline for API application?

The timeline will be the same as the time taken for product registration.

10. Who should submit the documents?

The Product Registration Holder (PRH) shall submit Part 2.S ACTD as part of online product application. Where any information required as per ACTD is not available the DMF will be required. While the API manufacturer shall submit the complete (open part and closed part) of the DMF.

11. What is the maximum file size acceptable for uploading into the online module?

Currently, Quest 3 only accepts any kind of documentation format with maximum size 5MB.

12. How do I submit the DMF to the NPCB?

The API Manufacturer may submit the DMF via electronic copy (CD) or hardcopy directly to the NPCB to maintain confidentiality of the contents upon the online submission of product registration.

The information contained in the restricted part of the DMF will be regarded as confidential and will only be evaluated in support of the applications mentioned in the Letter of Access. The confidential information will not be disclosed to any third party without a written authorization from the API Manufacturer.

13. What security procedure is NPCB putting in place for the submitted CDs, DVDs or Hardcopy of DMF?

The CDs, DVDs or Hardcopy of DMF will be stored in a secured environment.

14. What are the GMP requirements for the API manufacturer?

Current GMP certificate or any other evidence of GMP compliance from a regulatory authority (as deemed appropriate).

15. Does the API manufacturer need to be inspected?

Depending on the outcome of the evaluation of the API dossier, a risk-based approach will be used in the planning of inspections; the approach will take into account the type of APIs as well as the outcome, results and reports of inspections conducted by other regulatory authorities or competent organisations.

16. Does the NPCB accept CEP issued by the EDQM?

Yes, the NPCB will accept a CEP issued by EDQM in replacement of the DMF of the API.

17. What is the information need to be submitted if finish product contains more than one API?

If drug product contains more than one API, the information for each API must be provided.

18. Does the applicant need to send sample of the API to the NPCB?

Currently, NPCB did not ask for the submission of sample of the API for the purpose of registration. However the sample may be required during Post Market Surveillance activity.

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