2024: A Year in Review

The Bioequivalence and Ethics Committee (BEEC) Section's activities in 2024 reflect a period of both progress and ongoing development. The section undertook organisational changes, procedural refinements, and the issuance of new guidelines and directives, all within its core functions of inspections and evaluations. These activities contributed to the optimisation of its core functions and underscored the Section's strong commitment to operational excellence, positioning it for continuous success in upholding the highest regulatory standards and practices.

Operational Capacity: Expansion and Collaboration

The Section's operational capabilities were strengthened during 2024 with the addition of a senior inspector, increasing the number of officers to seven. The involvement of four officers from the Good Clinical Practice & Good Laboratory Practice Section and two officers from the Investigational Product Evaluation & Safety Section in planned inspections highlights a collaborative approach. While this collaboration is a positive aspect, the overall sufficiency of staffing levels to meet the demands of inspections and evaluations will be continually assessed to ensure effective and impactful deployment of resources.

Inspection Activities: Strategic Focus and Adjustments

BEEC Section conducted 26 inspections in 2024, covering facilities within Malaysia and abroad. While this represents a slight adjustment from the 29 inspections conducted in 2023, this shift reflects the completion of the ethics committee (EC) inspection cycle in the previous year. This allowed for a more focused deployment of resources in other key areas. Notably, a significant portion of inspections, 22 in total, were directed towards foreign BE centres. This emphasis on foreign inspections demonstrates a commitment to ensuring international standards are met, but it necessitates careful resource allocation to ensure adequate oversight of both foreign and local facilities.

Figure 1: Summary Infographic of BEEC Activities in 2024

Table 1: Bioequivalence Centres Inspected in 2024 (Status as of March 2025)

Table 2: Ethics Committees Inspected in 2024 (Status as of March 2025)

Evaluation on the need for BE study inspection (BEDE) Applications: Review of Outcomes and Trends

Figure 2: Cumulative Data of BEDE Applications (from August 2020 to March 2025) (n = 1,027)

The BEDE applications in 2024 showed 138 new applications, contributing to a cumulative total of 998 applications processed between August 2020 and 23 December 2024. From the cumulative total until March 2025, 70% of these applications were granted study-specific inspection exemptions, demonstrating a risk assessment based on the principle of regulatory reliance. Meanwhile 10% of applications require study-specific inspections, underscoring the rigorous nature of the evaluation process. It is worth noting that 16% of the total applications received were rejected or withdrawn, indicating a need for continuous refinement of existing guidance and for applicants to improve the quality of their submissions. As of 25 March 2025, all applications from 2020-2023 have been issued a decision, with 22 applications from 2024 are still under evaluation, highlighting the ongoing workload. 

Figure 3: Breakdown of all BEDE Applications Received in Each Year According to Outcome

Of the total BEDE applications reviewed, 100 applications required study-specific inspections before the BE study could be accepted to support product registration review. The number of applications requiring inspections varied across the years: 27 (10.0%) in 2020, 17 (9.8%) in 2021, 23 (11.2%) in 2022, 24 (11.5%) in 2023, and 9 (6.5%) in 2024 (as of March 14, 2025). While the 2024 figure is lower, it is essential to note that this reduction may be due to the improved scope of regulatory reliance, improved risk assessment matrix and overall decrease in the number of applications received. Furthermore, there's a trend of increasing applications for study-specific inspection from 2020 (3.7%) to 2022 (30.4%), but it dropped in 2023 (4.2%) and 2024 (11.1%). The sudden increase in study-specific inspection applications in 2022 may be due to the sudden influx of pending applications due to the Movement Control Order, which was lifted in 2022. On average, only 13% of BEDE applications with the decision that a study-specific inspection is required applied for study-specific inspections with the NPRA.

Figure 4: Percentage of BEDE Applications Applied for Study-Specific Inspections According to Year

Inspection Observations: Insights into the Quality of Facility and Study Inspections

There were 23 BE centre inspections in 2024, resulting in 349 observations, compared to 21 inspections with 362 observations in 2023. Most of these observations were classified as minor (81.1%), with the remaining 0.6% classified as critical and 18.3% as major. The presence of critical observations related to computerised system validations required robust corrective and preventive actions from the affected BE centre. The top three categories of observations were organisational aspects of clinical facilities [CL.2] (34.4%), organisational aspects of bioanalytical facilities [BA.1] (31.8%), and bioanalytical sample analysis [BA.3] (14.9%), suggesting areas where BE centres can focus on improving compliance.

Figure 5: Number of BE Centre Observations from Inspections Conducted in 2024 (n = 349)

There were three EC inspections in 2024, resulting in 77 observations compared to 139 observations from 7 EC inspections in 2023. Although the total number of observations has reduced in 2024, the average number of observations per inspection has increased. This is due to all three EC inspections involving new ECs for registration with the Drug Control Authority. Of the 77 observations, 40.3% were classified as major and 59.7% were minor. While the overall number of observations decreased, the proportion of major observations is reflective of new ECs that had not undergone any regulatory inspections. The major findings led to additional GCP Inspections at a trial site due to non-compliance of the EC in their approval procedure. The EC in question had not adhered to the regulatory requirement, which requires clinical trials approved by the EC to be registered with the National Medical Research Register (NMRR) and the protocol reviewed by the National Sub-Committee for Ethics in Stem Cell Research and Therapy (NSCERT) in clinical trials with stem cells as interventions. The top three categories of EC observations were related to the review procedure of ECs [EC.4] (35.1%), membership of ECs [EC.2] (28.6%) and procedures related to application processing by the EC [EC.3] (15.6%).

Figure 6: Number of Ethics Committee Observations from Inspections Conducted in 2024 (n = 77)

Process Refinements and Transparency: Progress and Implementation

In 2024, the BEEC Section made several internal process refinements aimed at improving efficiency and transparency. These initiatives are listed in Table 3.

Table 3: Publication (PB), Directives (DR) and Procedural Updates (PU) made in 2024

These initiatives aim at providing better clarity on existing procedures, allowing for improvement of the risk assessment matrix, and strengthening regulatory reliance. Digitisation of decisions and certificates aims at leveraging technology to improve process flows as well as reduce processing timelines.

The BEEC Section would like to remind all relevant stakeholders to ensure that all applicable guidelines and regulations are met. Applicants of BEDE are requested to ensure that a full inspection history of the BE centre is declared in BEDE applications. Applicants should also ensure that additional information requests are addressed in a timely manner and be conscious of the enforced one correspondence policy during the relevant stages of BEDE processing. BE centres on the NPRA programme should ensure that inspection applications for retention on the programme are submitted to the NPRA at least 15 months before the end of the current listing validity, and ECs registered with the DCA should ensure that all relevant guidelines, directives and regulations are met.

For more information on the relevant processes, please visit the BEEC webpage on the NPRA website.

The Section will continue with its process refinement activities, leverage technology and enhance industry engagements in 2025. The Section also plans to further improve transparency by publishing inspection results on the NPRA website and strengthening its involvement in the Association of Southeast Asian Nations (ASEAN) MRA BE initiative.