Evaluation of the Drug Regulatory Systems in Hong Kong, Singapore, Taiwan, United States and European Union

This dissertation, "Evaluation of the Drug Regulatory Systems in Hong Kong, Singapore, Taiwan, United States and European Union" by Tsz-ki, Chan, 陳紫琪, was obtained from The University of Hong Kong (Pokfulam, Hong Kong) and is being sold pursuant to Creative Commons: Attribution 3.0 Hong Kong License. The content of this dissertation has not been altered in any way. We have altered the formatting in order to facilitate the ease of printing and reading of the dissertation. All rights not granted by the above license are retained by the author. Abstract: Background: Drugs have become an essential necessity in public health, people and the government has become willingly to spend more money on the country's healthcare system to restore health, save lives, preventing disease and epidemics. Drugs should be properly regulated throughout development, production, importation and subsequent distribution to ensure it is prescribed with safe, effective and of good quality standards. The structure of drug regulations today has evolved over time. During the process, the scope of legislative and regulatory power expanded in result of a series of disastrous events related to pharmaceutical products, the adoption of more restrictive legislative were put in place for stronger safeguard to the public. In comparison to Singapore, Taiwan, US and EU where the drug regulatory system is highly structured, flexible and innovative, Hong Kong (HK) has a relatively simple and stubborn drug regulatory system and drug approval is greatly dependent on the approval status of the advance countries. According to the current registration system in HK, a new drug usually takes about 18-24 months to obtain an approval, and this figure is far behind the standard of Singapore in which medicine could be registered in 60 days. It is vital to have speedy approval process with high standards in safety, efficacy and quality on all approved drugs. If drugs are approved in a rush manner, it will lead to serious adverse drug reactions (ADR), or even deaths in consumption of unsafe, and ineffective drugs. On the other hand, slow approval will make patients suffer and increase the mortality rate to due inaccessibility of appropriate medicines to sustain life and combat diseases. With reference to the initiatives and innovative regulatory frameworks in the abovementioned countries, the modification of the local drug regulatory system is strongly recommended. Aim: 1. To examine the regulatory frameworks between Singapore, Taiwan, US and EU which affect the evaluation timeline required for new drugs approval. 2. As the first study to examine the drug regulations in HK, the regulatory barriers for new drugs submission will be explored and whether the regulatory initiatives from the abovementioned countries may result in an improvement in the overall drug regulation system HK. Method: This dissertation is a literature review and it will employ concentration in the drug regulation systems in Singapore, Taiwan, US and EU with varying levels of pharmaceutical regulation capacities. Search engines including Google, MedLine, PubMed (database up to 2012) with key words search of "Department of Health (DoH), Food and Drug Administration (FDA), European Union (EU), Taiwan FDA, Health Sciences Authority, evaluation routes, drug registration requirement, review timeline, Centre for Drug Evaluation, Pharmaceutical Evaluation Reports, risk management systems, pharmacovigilance, drug legislation." Results: With an in-depth evaluation of the HK's guideline and supporting document required for new drug submission, it is highly recommended that unnecessary documents at new drug submission (NDA) should be elimination to facilitate the new drugs approval process. The regulatory frameworks between all studied countries vary significantly in which implementation of initiatives (e.g. multiple evaluation routes, in-house evaluation system) from