Bioequivalence & Ethics Committee Section Activities in 2022: At A Glance

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The infographic above is a summary of activities conducted and coordinated by the Bioequivalence and Ethics Committee (BEEC) Section in 2022. The team consists of six personnel from Bioequivalence and Ethics Committee (BEEC) Section and assisted by eight officers from other sections who are seven officers from the Good Clinical Practice (GCP) & Good Laboratory Practice (GLP) Section and one officer from the Investigational Product Evaluation and Safety section.

In the year 2022, the team managed to conduct 19 inspections which include seven local Bioequivalence (BE) Centre inspections, five foreign BE Centre inspections and seven ethics committee (EC) inspections. Local BE Centre inspections had resumed in February 2022 with all seven inspections done on site either in the Klang Valley or Penang. Of the seven local BE Centre inspected, 5 inspections were surveillance inspections, while the remaining were certification and verification inspections. 

Foreign BE Centre inspections resumed in July 2022 after international travel restrictions were lifted in April 2022. Out of seven planned inspections, the team conducted five on-site inspections all over India including Ahmedabad, Tamil Nadu and Mumbai. Four inspections were certification inspections while one was a surveillance inspection. Two planned inspections were postponed to the year 2023 due to COVID-19. 

There were seven EC inspections done in 2022. Five inspections were surveillance inspections while the two remaining inspections were provisional inspections. Three inspections were carried out on site in the Klang Valley while four inspections were done remotely.

As of November 2022, BEEC had received 621 BEDE (Evaluation of the Need for BE Study Inspection) applications. Of the 621 applications, 65.22% (n=405) had received a decision whereby 58.78% (n=365) were exempted from study-specific inspections and 6.44% (n=40) required study specific inspections. 15.94% (n=99) of applications are currently in the evaluation phase and 2.90% (n=18) applications in the screening phase. Another 15.94% (n=99) of applications were rejected or withdrawn during the screening or evaluation process. All the remaining applications are expected to receive an outcome in the year 2023.

Going into 2023, the team will be looking into optimising the workforce whilst finding the balance between the conduct of inspections and evaluating BEDE applications. BEEC Section will continue to upscale the number of inspections with plans to conduct 29 inspections including local BE Centres, foreign BE Centres and EC inspections in 2023. The majority of these inspections are foreign BE Centre inspections as the team will be focusing on clearing backlog applications from the year 2020 – 2021 brought about by pandemic travel restrictions. The number of BEDE application is also expected to increase in 2023. Process refinements will continue as the team work to ensure that all applications can be reviewed within the specified timeline. The team commits to participation in stakeholder dialogues and involve in trainings for the industry to better support the process optimisation and manage expectations.

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 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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