Achievement Of NPRA's Clients’ Charter For Year 2016 (January – December)

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No.

Our Promise

Target

Achieve Expectation

Below Expectation

Total

Number

Percentage

Number

Percentage

1.

To evaluate application for registration of:

        Prescription Drugs

210 working days

123

73.65%

44

26.35%

167

        Non-prescription Drugs

210 working days

31

100%

0

-

31

        New Drugs and Biologicals

245 working days

93

98.9%

1

1.06%

94

2.

To evaluate application for registration of traditional products containing:

         Single active ingredient

116 working days

164

85.8%

27

15.5%

191

        2 or more active ingredients

136 working days

352

83.0%

72

17.0%

424

To evaluate application for registration of health supplements containing:

         Single active ingredient

116 working days

78

100%

0

-

78

         2 or more active ingredients

136 working days

158

98.75%

2

1.25%

160

3.

To evaluate application for registration of non-prescription drugs (as stated in  Table V Drug Registration Guidance Document) containing:

         Single active ingredient

116 working days

6

100%

0

-

6

         2 or more active ingredients

136 working days

6

100%

0

-

6

4.

Issuance of Cosmetic Notification

1 working day

63,821

100%

0

-

63,821

5.

Certificate of Free Sale (CFS) for Cosmetics

15 working days

2,470

100%

0

-

2,470

6.

Decision on application for change of registration holder

45 working days

333

100%

0

-

333

7.

 Certificate of Pharmaceutical Product (CPP)

15 working days

2,323

100%

0

-

2,323

8.

Certificate of Free Sale (CFS)

15 working days

35

100%

0

-

35

7.

Decision on application for change of manufacturing site

60 working days

490

88.9%

61

11.1%

551

9.

Issuance of manufacturer's,

wholesaler's and importer's license

4 working days

1,698

93.9%

110

6.1%

1,808

10.

Evaluation of Import License Application for Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) :

      For products involving Phase 1 study, biological products, Cell & Gene Therapy Products (CGTPs) and herbal products

45 working days

58

100%

0

-

58

      For products other than stated above

30 working days

129

100%

0

-

129

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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