Revision of timelines for variation applications of registered products [pharmaceutical products & natural and health supplement products (TMHS)] and a pilot study

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For information, NPRA is continuously working towards improved efficiency, not only for pre-marketing product assessments but also for post-approval changes. To provide greater clarity and more effective monitoring, we are in the plan to revise the current timelines for variation applications outlined in the Malaysian Variation Guideline for Pharmaceutical Products (MVG), Malaysian Variation Guideline for Biologics (MVGB), and Malaysian Variation Guideline for Natural and Health Supplement Products.

Before finalising these new timelines, a pilot study with a duration of 1 year will be conducted, starting on June 1, 2024. Table 1 displays the proposed new timelines. We advise all PRHs to plan their submissions in accordance with these new timelines. However, please note that NPRA will not reject variation applications that exceed the maximum number of permitted variation types per registered product as listed in Table 1. Instead, the timelines may be extended beyond the new timelines.

For any inquiries, please direct your email to the relevant officers as follows:

i. New Drug Products: Ms Yap Kian Yee (0378835586/ Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.)

ii. Biologics: Ms Lim Bee Yee (0378835589/ Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.)

iii. Generics: Ms Haw Shin Ee (0378835543/ Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.)

iv. Health Supplements: Mr Daniel Ho Yu Kun (0378835579/ Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.)

v. Natural Products: Ms Monica Yeoh Siu Cheng (0378835592/ Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya.)

 

Table 1: Revised variation timelines

Variation (Pharmaceutical products)

MiV-N or

MiVB-N

35 wd (maximum of 5*)

 

*Applicant may submit up to a maximum of 5 concurrent MiV-N/MiVN-B applications per registered productThe review timeline may be extended if more than 5 concurrent MiV-N/MiVN-B applications are submitted.

MiV-PA or

MiVB-PA

 

80 wd (maximum of 5*)

 

*Applicant may submit up to a maximum of 5 concurrent MiV- PA/MiVB-PA applications per registered productThe review timeline may be extended if more than 5 concurrent MiV- PA/MiVB-PA applications are submitted

 

*Inclusion of a new category under MiV- PA/MiVB-PA on safety-related changes – Tell & do

 

“Tell & Do” If the application fulfils the requirements as per MVG/MVGB Guideline, NPRA shall approve the proposed change. Changes can be implemented immediately after submission

MaV or

MaVB

120 wd (maximum of 3*)

 

*Applicant may submit up to a maximum of 3 concurrent MaV/MaVB applications per registered productThe review timeline may be extended if more than 3 concurrent MaV/MaVB applications are submitted.

Grouping (bundle applications)

 

150 wd (maximum of 5 variation applications including a maximum of 3 MaV/MaVB applications*)

 

*Applicant may submit up to a maximum of 5 variation applications concurrently including a maximum of 3 MaV/MaVB applications per registered product. The review timeline may be extended if more than 3 concurrent MaV/MaVB applications are submitted.

Variation (Natural and Health Supplement products - TMHS)

MiV-N

 

10 wd (maximum of 5*)

 

*Applicant may submit up to a maximum of 5 concurrent MiV-N applications per registered productThe review timeline may be extended if more than 5 concurrent MiV-N applications are submitted.

MiV-PA

 

70 wd (maximum of 5*)

 

*Applicant may submit up to a maximum of 5 concurrent MiV- PA applications per registered productThe review timeline may be extended if more than 5 concurrent MiV- PA applications are submitted

MaV

 

100 wd (maximum of 3*)

 

*Applicant may submit up to a maximum of 3 concurrent MaV applications per registered productThe review timeline may be extended if more than 3 concurrent MaV applications are submitted.

Grouping (bundle applications)

120 wd (maximum of 5 variation applications including a maximum of 3 MaV applications*)

 

*Applicant may submit up to a  maximum of 5 variation  applications concurrently including a maximum of 3 MaV applications per registered product. The review timeline may be extended if more than 3 concurrent MaV applications are submitted.

Wd: working days

 

Notes to PRHs: 

1. Timelines for PRH to reply according to the category of products and variation types are as follows: failure to meet these timelines may result in application rejection.

a) For pharmaceutical products: 45 wd (for MiV-PA and MiVB-PA) and 60 wd (for MaV, MaVB, Grouping/Bundle applications)

b) For TMHS products: 20 wd (for MiV-PA) and 30 wd (for MaV, Grouping/Bundle applications)

 

2. For pharmaceutical products only: To ensure a smooth process, all PRHs must attach a cover letter/summary of changes for the intended variation application via Quest3+. The cover letter/summary of changes should include the following:

a) Proposed variation category

b) A brief description of the proposed variation with justification

c) A declaration confirming the fulfillment of all requirements within the suggested category

d) Approvals from the country of origin's National Regulatory Agency or reference agencies (if any)

e) Current and proposed changes to the dossier's tabulated format information

f) A declaration that there is no change except for the proposed change

 

For more information, kindly refer to the Frequently Asked Questions (FAQs).

Thank you.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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