1. New Drug Product
2. Generic Product containing Scheduled Poison
3. Generic Product NOT containing Scheduled Poison(implementation date to be determined)

The following categories of product are excluded from API regulatory control:

1. Traditional products
2. Veterinary products
3. Health supplement products
4. Biological and biotechnology products

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

1. New Product Applications (with New Chemical Entity):                                       1 Jan 2012
2. New Generic Products - Parenteral Dosage Form:                                               1 Jul 2014
3. New Generic Products - Oral Dosage Form:                                                          1 Jul 2016
4. New Generic Products – All Dosage Forms:                                                           1 Jul 2017            
5. Registered Products for Registration Renewal (Scheduled Poison )                  1 Jan 2020
6. New Generic Products NOT containing Scheduled Poison                                  To be Determined

Separate registration for stand-alone API is not implemented by NPRA. Each API will be regulated as part of the finished pharmaceutical product. The required technical documentation pertaining to each API should be submitted with a product registration application.

Processing fee is not required as the API application is already incorporated in the product registration application.

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

The Product Registration Holder (PRH) shall submit API information (Part II - Section S) as part of the online product application. If the API information is available in Drug Master File (DMF), the PRH shall submit information of DMF (open part) in QUEST online system and request the DMF holder to provide complete DMF (both open part and close part) to NPRA (refer Q10).

Currently, QUEST system only accepts PDF format with maximum size of 5MB.

The API Manufacturer/DMF holder shall submit the DMF via electronic copy (CD) directly to the NPRA to maintain contents confidentiality before* the PRH make an online submission via QUEST. This DMF submission shall accompanied with a Letter of Access (LOA) and a cover letter **that states the following:

• Name of the finished product
• Local PRH responsible for finished Product;
• A declaration that both the local PRH and the NPRA shall be notified of any change in the API specification or in the manufacturing process that will likely affect the product’s quality or safety.

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. This confidential information will not be disclosed to any third party without a written authorization from the API Manufacturer.

*The DMF shall reach NPRA before the online submission.
**Template of Cover Letter is available on NPRA website

Valid GMP certificate from a regulatory authority (as deemed appropriate) must be provided for all manufacturers involved in the API manufacturing process.

Separate API information should be submitted when:

• A finished product contains more than one API;
• The API is manufactured from more than one manufacturing site;
• The API is manufactured using more than one synthesis route

Currently, NPRA does not require the submission of sample of the API for the purpose of registration. However, the sample may be required during Post Market Surveillance activity.