The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced (...) including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area. (shrink)

A board of directors consists of a set of key personnel that hold vital positions in a company. Based on the premise of the resource dependence theory, we explore the association between board diversity and innovation performance in Malaysia. The sample consists of 220 companies from the industrial product sector of the main market of Bursa Malaysia for the financial year 2013. Board diversity is represented by a comprehensive score that includes age, gender, ethnicity, nationality, education, tenure, area of experience (...) and directorship in other companies. Results of the regression analysis show that there is a positive association between board diversity and innovation performance. Our findings contribute to the policy involving the diversity of corporate boards by suggesting that policy, such as one of gender diversity in Malaysia, is expanded to include multi-dimensional aspects of board diversity that better represent the economic, legal and cultural environment of a country. (shrink)