Step 4 : Evaluation of Application

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4.1 INITIATION OF REVIEW

Upon confirmation of payment, the application with the submitted data shall be evaluated. Review of applications shall follow a queue system. There shall be separate queues for the different categories of products and/or according to level of claims (e.g. general, medium or high claim for health supplements).

 

4.2 PRIORITY REVIEW

1. Priority review may be granted for new product application (in the category of New Drug Products, Biologics and Generics) which fulfils either one of the following conditions;

a) Product which is intended for:

  1. Unmet medical needs (e.g. medicines for rare diseases, new vaccines, etc.),
  2. Life-saving such as for treatment/ prevention of serious medical conditions (e.g. anticancer, antiretroviral, etc.),
  3. Treatment/ prevention in pandemic/ endemic situations, for the interest of public health,
  4. Emergency supply/ crucial for treatment purpose according to the current needs in the country,
  5. Supply to the Ministry of Health Malaysia under circumstances where alternative product with the same active ingredient is unavailable,

b) Product which involves a change in the formulation due to the decision/ instruction by the Drug Control Authority (DCA), for the purpose of formulation improvement with appropriate scientific justification(s),

c) Product which is the first generic product, or the first locally manufactured generic product.

 

2. An application for Priority Review should be submitted via a formal letter addressed to the Director of NPRA once the screening has been approved.

 

3. The approval of Priority Review is subjected to the decision of the Drug Evaluation Committee Meeting upon submission of complete product registration documentation and does not exempt applicant from any product registration requirements.

 

4. The timeline for evaluation for product granted Priority Review is as below;

No.

Product Category

Duration

(Starting from the date of approval of Priority Review)

(A)

Full Evaluation

1.

Generics (Scheduled Poison)

100 working days

2.

Generics (Non-Scheduled Poison)

100 working days

 

4.3 CORRESPONDENCE

Correspondence via the system shall be sent to the applicant if there is any clarification and further supplementary data/ information or documentation pertaining to the application, if deemed necessary by the Authority.

 

Application shall be rejected if the applicant fails to respond to the correspondence from NPRA to submit the required supplementary data/ information or documentation within six (6) months from the first correspondence date.

 

4.4 TIMELINE FOR PRODUCT REGISTRATION

Table VIII:

No.

Product Category

* Duration

(Inclusive screening process)

(A)

Full Evaluation

1.

Generics (Scheduled Poison)

210 working days

2.

Generics (Non-Scheduled Poison)

210 working days

(B)

Abridged Evaluation

*Duration

(Inclusive screening process)

3.

Generics (Non-Scheduled Poison)

(Product categories as stated in Table V above)

a)      Single active ingredient

b)      Two (2) or more active ingredients

a)      116 working days

b)      136 working days

 

 

 

 

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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