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.
OBJECTIVE: The aim of this study was to identify types of image repair strategies utilized by the Malaysian government in their communication about COVID-19 in the media and analyze public responses to these messages on social media.
METHODS: Content analysis was employed to analyze 120 media statements and 382 comments retrieved from Facebook pages of 2 mainstream newspapers-Berita Harian and The Star. These media statements and comments were collected within a span of 6 weeks prior to and during the first implementation of Movement Control Order by the Malaysian Government. The media statements were analyzed according to Image Repair Theory to categorize strategies employed in government communications related to COVID-19 crisis. Public opinion responses were measured using modified lexicon-based sentiment analysis to categorize positive, negative, and neutral statements.
RESULTS: The Malaysian government employed all 5 Image Repair Theory strategies in their communications in both newspapers. The strategy most utilized was reducing offensiveness (75/120, 62.5%), followed by corrective action (30/120, 25.0%), evading responsibilities (10/120, 8.3%), denial (4/120, 3.3%), and mortification (1/120, 0.8%). This study also found multiple substrategies in government media statements including denial, shifting blame, provocation, defeasibility, accident, good intention, bolstering, minimization, differentiation, transcendence, attacking accuser, resolve problem, prevent recurrence, admit wrongdoing, and apologize. This study also found that 64.7% of public opinion was positive in response to media statements made by the Malaysian government and also revealed a significant positive association (P=.04) between image repair strategies utilized by the Malaysian government and public opinion.
CONCLUSIONS: Communication in the media may assist the government in fostering positive support from the public. Suitable image repair strategies could garner positive public responses and help build trust in times of crisis.