Active Pharmaceutical Ingredient (API)

1.1. A significant part of the quality of a finished product is dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper system of qualification of suppliers is necessary to ensure a constant sourcing of APIs of appropriate quality and to safeguard the public health interests. This will be done through standardized quality assessment and inspection procedures.

1.2 The National Pharmaceutical Control Bureau (NPCB) under the purview of the Ministry of Health Malaysia has introduced mandatory control of APIs as part of the requirements in the product registration application.

1.3. The implementation began with voluntary submission for New Chemical Entities in April 2011 and followed by;
· Phase 1 - New Chemical Entity (January 2012)

· Phase 2 - Scheduled Poison

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

Registered Product (Pharmaceutical products containing Scheduled Poison):-

All Dosage Form : Expire on 1 January 2020 onwards

* API Information must be submitted at least one year before the expiry date.

[Reference: Directives dated 17 March 2011 Bil (12) dlm BPFK/PPP/01/03 Jld 1 and dated 16 January 2014 BPFK/PPP/07/25 (7), Circular dated 27 June 2014 Bil (11) dlm BPFK/PPP/01/03 Jld 3 ]

· Phase 3 - Generic Product NOT containing Scheduled Poison (to be determined)

1.4. The procedure for control of APIs established by the NPCB is based on the following principles:

· A general understanding of the production and quality control activities of the manufacturer;
· Assessment of API data and information, including changes and variations, submitted by the product registration holder (PRH)/ API manufacturer. These data should include the manufacturing process, material specifications and test data and results; 
· Assessment of the manufacturing site(s) for consistency in production and quality control of raw materials, with specific emphasis on key raw materials and APIs during and after purification through compliance with Good Manufacturing Practice (GMP); 
· Random sampling and testing of APIs (post-marketing surveillance); 
· Handling of complaints and recalls; and 
· Monitoring of complaints from other agencies and countries. 

1.5. The guideline is intended to provide guidance regarding the requirements to be included for APIs in the quality part of the product dossier (Part II-S)



· 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 or to affect the structure and function of the body (WHO Technical Report Series No.970,2012). 


API classification can be divided into:
o Inorganic substances; 
o Organic substances (isolated from materials of animal or human origin); and 
o Organic substances (synthetic or semi-synthetic or isolated from herbal sources or micro-organisms).

3.1. The guideline encompasses the APIs of new products for registration and current/ existing registered products. This is applicable to all pharmaceutical products (excluding traditional products, veterinary products, and health supplement products) both locally manufactured and imported.

3.2. Biological active substances and immunological active substances are excluded from the scope of this guideline. Please refer to relevant guidelines available for Biologics.

3.3. APIs used in products for export only (FEO) are exempted from the requirement for submission of the Drug Master File (DMF) and Certification of Suitability (CEP) in the product application.

3.4. The API information required as in this guideline is only applicable for final APIs and not API intermediates

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

3.6. Assessment of an API will be performed once submission of a new product registration application has been done. 

3.7. Assessment of an API will also be performed for a registered product prior to a product renewal application (as stated in item 1.3).

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
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