Search

Southeast Asian countries are at the forefront of public health pressures due to a confluence of factors such as population growth, urbanization, environmental pollution, and infectious diseases (re)emergence. Therefore, the ability to be able to conduct research addressing local and regional needs is of paramount importance. As such, biobanking activities, the standardized collection of biological samples, and associated data, developed over the past few decades supporting ongoing biomedical and clinical research, as well as surveillance are of critical importance. However, the regulatory landscape of biobanking is not widely understood and reported, which this narrative review aims to address for the ASEAN member states. It is evident that there are specific regulatory arrangements within each ASEAN member state, which though may be sufficient for the current level of operations, are unlikely to support a regional sharing of biological samples, data, and eventually benefits from the conducted research. Additionally, legacy and often-overlapping regulatory frameworks exist, which raise the need of an eventual consolidation under a single framework. Thus, this field requires further study as well as the creation of viable, practical proposals that would allow for biobanking harmonization and thus the exchange of biological samples and data to be achieved regionally, if not further afield.

Objectives: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center., Methods: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members., Results: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers., Conclusion: Based on the SWOT analysis and market, technical, financial, and organizational considerations, re-establishing the BA/BE Unit as a bioequivalence testing center is feasible., Competing Interests: The authors have no real conflict of interest since the researchers’ involvement has no direct impact in the results of or conduct of the study. Reflexivity was practiced by the researchers to make sure that assumptions and beliefs will have minimal influence on the research process., (© 2024 Acta Medica Philippina.)