Malaysia, guidance document for the pre-submission meeting.

Malaysia, guidance document for the pre-submission meeting.

On 13th February 2020, the Guidance Document for Pre-Submission Meeting (PSM) was unveiled.

PSM a new service provided by the Nationalized Regulatory Division of Pharmacy. A platform intended for product registration holders to ask questions and seek clarification on product quality, safety and efficacy during the product development stage.

Their current focus is on 4 product categories:

1.      New drug products;
2.      Biologic products (including biosimilar products);
3.      Natural products with therapeutic demands;
4.      Health supplement products with the risk of disease reduction.

Issues related to the application for a manufacturer license or Good Manufacturing Practice (GMP) certification are not covered by the scope of the PSM.

For the start of this new implementation, the total number of meetings will be limited to 1 session per month, a maximum of 2 PSM sessions per product.

Product registration holders interested in getting PSM services can do so by followings the below-mentioned steps:

1.      Complete the PSM request form from www.npra.gov.my.

2.      Make sure you are a locally incorporated company, corporate or legal entity, with a permanent address and registered with Companies Commission of Malaysia.

3.      Ensure PSM request form is emailed at least 8 weeks in advance before the proposed meeting
date to presubmission@npra.gov.my.

4.      NPRA will then review and screen the applications.

·        If approved, applicants will be notified with the confirmation.
·        If not approved, applicants will also be notified and introduced to other alternatives.

Refer to the procedure (Via the link) in the Guidance Document for Pre-Submission Meeting (PSM) guidelines for more information.
https://bit.ly/3aonJ67

The services offered are non-mandatory. However, any advice provided by NPRA during the PSM is non-binding, taking into account the regulatory developments that may change from time to time.

The implementation of this new implementation would officially be on 15th March 2020.