METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials.
RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing.
CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.
METHODS: The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for new active substances and biosimilars approved by NPRA in 2017.
RESULTS: In 2017, 25 new active substances and 1 biosimilar were approved by NPRA in a median of 515 days, representing both agency and applicant time. The median time between dossier receipt and the initiation of NPRA scientific assessment was 135 days, but there was a wide variation in queuing time. The median total assessment time was 279 days (agency and applicant timing). NPRA took a median of 166 days; applicants took a median of 131 days to respond to deficiency questions, with up to 6 cycles of review required for approval and 65% of applications requiring 4-5 cycles to provide satisfactory responses.
CONCLUSIONS: As a result of these data, NPRA proposes three improvements: target start for scientific assessment 100 days after file acceptance, a maximum of 5 review cycles, and applicant response time limited to 6 months. These results will serve as a baseline for further assessment.
Patients and Methods: The data were collected from 35 experts by using a bipolar questionnaire. The study applied an analytical hierarchal process (AHP) for prioritization factors contributing to willingness to donate and then selection of a suitable organ donation system based on prioritized factors.
Results: Based on the AHP results, it is evident that donation perception (0.36) has the highest priority in influencing organ donation rates, followed by socioeconomic status (0.32), demographic factors (0.23), and financial incentives (0.09). Further, our results challenge the existing opt-in donation system in Malaysia and present a presumptive approach as a suitable system for increasing deceased donation rate in Malaysia. Presumptive approach promotes the role of health-care professionals in securing the family consent.
Conclusion: This approach is a person-oriented rather than process-oriented strategy and it relies on designated requesters' skills to evoke altruism among bereaved families. Based on results, the authors recommended that relevant government agencies focus on training nurses to discuss donation with bereaved families and raising public awareness.