Virtual Q&A Session: Evaluation on the Need for Study Specific Inspections for Bioequivalence (BE) Studies [Registration Closed]

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Introduction

Directive No 12/2020 by the Director of Pharmaceutical Services, Ministry of Health Malaysia had been issued on the implementation of the Evaluation on the Need for Study Specific Inspections for BE Studies.

Under this directive, BE studies that were conducted at BE centres not listed under the NPRA BE Centre Compliance Programme or at listed facilities before listing will be evaluated on a Risk-based approach. This mechanism is implemented to evaluate the need for study-specific inspections by NPRA.

The affected BE studies will only be accepted to support the application of product registration once the evaluation on the need for study-specific inspection is successful. This new evaluation process will only provide exemptions for study-specific inspection should the application succeed.

The effective date of this directive is from 21st July 2020.

Application form and manual can be accessed in NPRA website at the following link:

https://www.npra.gov.my/index.php/en/application-forms-and-checklist.html

 

A virtual Q&A session will be held via Skype for Business. Details are as below:

Date: 10th August 2020

Time: 10:00 am – 12:00 pm

 

Objective

1. To provide exposure and explanation regarding the implementation of the new directive.

2. To answer any questions related to the application for evaluation on the need for study specific inspections for BE studies.

 

Agenda

Agenda for this session can be accessed through this link: Agenda Virtual Q&A Session

 

Registration

No registration fee.

Kindly register using this link: http://tiny.cc/409ksz

Link to Skype for Business and slides presentation will be shared after registration closes.

Registration closing date: 2nd August 2020

 

Registration closed. However, any questions related to the implementation of the new directive can still be submitted using this form: http://tiny.cc/mn8ksz.

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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